Trial Outcomes & Findings for Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection (NCT NCT02178592)

NCT ID: NCT02178592

Last Updated: 2021-01-12

Results Overview

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA \<50 copies/milliliter was assessed at Week 48 using the snapshot algorithm in the DTG arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA \>=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of investigational product \[IP\] prior to visit window) are also considered as non-responders, as well as participants with anti-retroviral (ART) substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 113 participants
• Primary outcome timeframe: Week 48
• Results posted on: 2021-01-12

Participant Flow

This study was conducted in 7 countries across 25 centers; Argentina (2), Brazil (4), Mexico (3), Peru (4), Russia (2), South Africa (8) and Thailand (2). Participants were randomized to receive either Dolutegravir (DTG) or Efavirenz (EFV) containing regimens.

A total of 263 participants were screened of which 150 were screen failures. A total of 113 participants were enrolled in this study.

Participant milestones

Measure	DTG 50 mg Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Randomized Phase (Up to Week 52) STARTED	69	44
Randomized Phase (Up to Week 52) COMPLETED	50	35
Randomized Phase (Up to Week 52) NOT COMPLETED	19	9
OLE Phase (Week 52 to Week 252) STARTED	47	19
OLE Phase (Week 52 to Week 252) COMPLETED	35	16
OLE Phase (Week 52 to Week 252) NOT COMPLETED	12	3

Reasons for withdrawal

Measure	DTG 50 mg Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Randomized Phase (Up to Week 52) Adverse Event	0	2
Randomized Phase (Up to Week 52) Lack of Efficacy	1	1
Randomized Phase (Up to Week 52) Protocol Violation	3	2
Randomized Phase (Up to Week 52) Withdrawal by Subject	3	1
Randomized Phase (Up to Week 52) Lost to Follow-up	11	3
Randomized Phase (Up to Week 52) Physician Decision	1	0
OLE Phase (Week 52 to Week 252) Adverse Event	1	0
OLE Phase (Week 52 to Week 252) Lack of Efficacy	0	1
OLE Phase (Week 52 to Week 252) Protocol Violation	2	0
OLE Phase (Week 52 to Week 252) Withdrawal by Subject	4	1
OLE Phase (Week 52 to Week 252) Reached Protocol defined stopping criteria	2	0
OLE Phase (Week 52 to Week 252) Lost to Follow-up	3	1

Baseline Characteristics

Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection

Baseline characteristics by cohort

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.	Total n=113 Participants Total of all reporting groups
Age, Continuous	34.6 Years STANDARD_DEVIATION 10.25 • n=5 Participants	33.1 Years STANDARD_DEVIATION 7.56 • n=7 Participants	34.0 Years STANDARD_DEVIATION 9.29 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	16 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	28 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	47 Participants n=5 Participants	28 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Intent-to-treat exposed (ITT-E) Population comprised of all randomly assigned participants who received at least one dose of IP.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter was assessed at Week 48 using the snapshot algorithm in the DTG arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA >=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of investigational product [IP] prior to visit window) are also considered as non-responders, as well as participants with anti-retroviral (ART) substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/Milliliter at Week 48 in DTG Arm Using the Modified United States (US) Food and Drug Administration (FDA) Snapshot Algorithm	75 Percentage of participants Interval 65.0 to 86.0	—

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter were assessed at Week 48 using the snapshot algorithm in the EFV arm. Response was assessed using a modified FDA Snapshot algorithm in which participants were not penalized for any single protocol allowed background therapy substitution even if occurs after the first trial visit. In this approach participants with HIV-1 RNA >=50 copies/milliliter are considered as non-responders. Participants without HIV-1 RNA data at Week 48 (due to missing data or discontinuation of IP prior to visit window) are also considered as non-responders, as well as participants with ART substitutions were not permitted. Study drug (i.e. DTG or EFV) was not allowed to be substituted.

Outcome measures

Measure	DTG 50 mg n=44 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 48 in EFV Arm Using the Modified Snapshot Algorithm	82 Percentage of participants Interval 70.0 to 93.0	—

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population

Plasma samples were collected for quantitative analysis of HIV-1 RNA. The percentage of participants with plasma HIV-1 RNA <50 copies/milliliter were assessed at Week 24 using the snapshot algorithm in the DTG and EFV arm. Response was assessed according to the Modified Snapshot algorithm. In this approach participants with HIV-1 RNA >=50 copies/milliliter were considered non-responders. Participants without HIV-1 RNA data at Week 24 (due to missing data or discontinuation of IP prior to visit window) were also considered as non-responders, as well as participants with ART substitutions were not permitted. Substitution of a background NRTI agent was permissible one time if it was due to reasons of drug toxicity.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/Milliliter at Week 24 in Both EFV and DTG Arms Using the Modified Snapshot Algorithm	81 Percentage of participants Interval 72.0 to 90.0	89 Percentage of participants Interval 79.0 to 98.0

SECONDARY outcome

Timeframe: Week 24 and Week 48

Population: ITT-E Population

Percentage of participants not meeting confirmed virologic withdrawal criteria nor discontinued due to treatment related reasons at the time of analysis at Week 24 (through Day 210) and Week 48 (through Day 350) has been presented by treatment group. The time to meeting confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons (i.e., discontinuation due to drug-related adverse event [AE], or due to protocol defined safety stopping criteria, or due to lack of efficacy) were calculated. Participants who met confirmed virologic withdrawal criteria or discontinuation due to treatment related reasons were considered as Failure. Participants who had not met confirmed virologic withdrawal criteria (per protocol) and were ongoing in the study, or who had discontinued for reasons other than those related to treatment, were censored. This would be the Treatment-Related Discontinuation = Failure (TRDF) data.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 Week 24	98.4 Percentage of participants Interval 89.1 to 99.8	95.2 Percentage of participants Interval 82.1 to 98.8
Percentage of Participants Without Confirmed Virologic Withdrawal and Without Discontinuation Due to Treatment-related Reasons at Week 24 and Week 48 Week 48	96.6 Percentage of participants Interval 87.0 to 99.1	92.7 Percentage of participants Interval 79.1 to 97.6

SECONDARY outcome

Timeframe: Baseline (Day 1), 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 samples were collected for assessment of lymphocyte subsets (CD4+ lymphocyte count) by flow cytometry at Baseline and Weeks 24, 48. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from Baseline was calculated subtracting the value at the specified time point from the Baseline value.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 Week 24, n=61,41	153.2 Cells per millimeter^3 Standard Deviation 125.09	127.1 Cells per millimeter^3 Standard Deviation 158.14
Change From Baseline in Cluster of Differentiation 4 (CD4+) Counts at Week 24 and Week 48 Week 48, n=49, 33	199.0 Cells per millimeter^3 Standard Deviation 146.22	194.5 Cells per millimeter^3 Standard Deviation 137.81

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Population comprised of all participants who received at least one dose of IP.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (>=5%) non-SAE over 52 weeks has been summarized.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase Common Non-SAE	38 Participants	33 Participants
Number of Participants With Serious Adverse Event (SAE) and Common (>=5%) Non-serious AE (Non-SAE) - Randomized Phase SAE	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 52 to Week 252

Population: Safety OLE Population comprised of all participants in Safety Population who entered the OLE phase.

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, all events of possible drug-induced liver injury with hyperbilirubinemia or any other situation according to medical or scientific judgment. Data for number of participants with SAE and common (>=5%) non-SAE from Week 52 to Week 252 has been summarized.

Outcome measures

Measure	DTG 50 mg n=47 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=19 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase Common Non-SAE	36 Participants	16 Participants
Number of Participants With SAE and Common (>=5%) Non-SAE - OLE Phase SAE	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Population

Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants who experienced maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using Division of Acquired Immune Deficiency Syndrome (DAIDS) toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase ALT, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Cholesterol, Grade 2	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Creatine kinase, Grade 1	3 Participants	4 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Creatine kinase, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Creatinine, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Glucose, Grade 2	3 Participants	5 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Glucose, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase LDL cholesterol calculation, Grade 1	0 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Phosphate, Grade 1	5 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Potassium, Grade 1	5 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Potassium, Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Sodium, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Sodium, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Alkaline phosphatase, Grade 1	7 Participants	11 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Alkaline phosphatase, Grade 2	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Alkaline phosphatase, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Alkaline phosphatase, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase ALT, Grade 1	10 Participants	9 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase ALT, Grade 2	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase ALT, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Albumin, Grade 1	2 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Albumin, Grade 2	8 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Albumin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Albumin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase AST, Grade 1	11 Participants	8 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase AST, Grade 2	4 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase AST, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase AST, Grade 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Bilirubin, Grade 1	3 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Bilirubin, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Bilirubin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Bilirubin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Carbon dioxide, Grade 1	14 Participants	8 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Carbon dioxide, Grade 2	4 Participants	4 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Carbon dioxide, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Carbon dioxide, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Cholesterol, Grade 1	5 Participants	6 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Cholesterol, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Creatine kinase, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Creatine kinase, Grade 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Creatinine, Grade 1	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Creatinine, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Creatinine, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Glucose, Grade 1	11 Participants	10 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Glucose, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase LDL cholesterol calculation, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase LDL cholesterol calculation, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase LDL cholesterol calculation, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Lipase, Grade 1	2 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Lipase, Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Lipase, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Lipase, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Phosphate, Grade 2	3 Participants	5 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Phosphate, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Phosphate, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Potassium, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Potassium, Grade 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Sodium, Grade 1	17 Participants	9 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities - Randomized Phase Sodium, Grade 2	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to Week 252

Population: Safety Population

Blood samples for assessment of clinical chemistry parameters were collected at indicated time points. Clinical chemistry assessments included ALT, albumin, alkaline phosphatase, AST, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, glucose, LDL cholesterol calculation, lipase, phosphate, potassium, and sodium. Data for number of participants with maximum post-Baseline emergent chemistry toxicities were summarized. Maximum post-Baseline emergent chemistry toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating) . Higher grade indicates more severity.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Sodium, Grade 2	3 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Sodium, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Sodium, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase ALT, Grade 2	3 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase ALT, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase ALT, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Albumin, Grade 1	2 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase AST, Grade 1	14 Participants	8 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase AST, Grade 2	6 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase AST, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Bilirubin, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Carbon dioxide, Grade 1	16 Participants	10 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Cholesterol, Grade 2	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Creatine kinase, Grade 4	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Creatinine, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Glucose, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase LDL cholesterol calculation, Grade 1	0 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Potassium, Grade 1	8 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Sodium, Grade 1	22 Participants	9 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase LDL cholesterol calculation, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Lipase, Grade 1	3 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Bilirubin, Grade 1	7 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Bilirubin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Bilirubin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Carbon dioxide, Grade 2	5 Participants	4 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Carbon dioxide, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Carbon dioxide, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Cholesterol, Grade 1	5 Participants	6 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Cholesterol, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Creatine kinase, Grade 1	7 Participants	4 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Creatine kinase, Grade 2	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Creatine kinase, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Creatinine, Grade 1	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Creatinine, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Creatinine, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Glucose, Grade 1	12 Participants	12 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Glucose, Grade 2	7 Participants	5 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Glucose, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase LDL cholesterol calculation, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase LDL cholesterol calculation, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Lipase, Grade 2	0 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Lipase, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Lipase, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Phosphate, Grade 1	5 Participants	5 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Phosphate, Grade 2	10 Participants	7 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Phosphate, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Phosphate, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Potassium, Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Potassium, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Potassium, Grade 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase ALT, Grade 1	12 Participants	10 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Albumin, Grade 2	8 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Albumin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Albumin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Alkaline phosphatase, Grade 1	8 Participants	12 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Alkaline phosphatase, Grade 2	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Alkaline phosphatase, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase Alkaline phosphatase, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Chemistry Toxicities- Randomized Phase + OLE Phase AST, Grade 4	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Population

Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Hemoglobin, Grade 1	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Hemoglobin, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Hemoglobin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Hemoglobin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Leukocytes, Grade 1	4 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Leukocytes, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Leukocytes, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Leukocytes, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Neutrophils, Grade 1	6 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Neutrophils, Grade 2	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Neutrophils, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Neutrophils, Grade 4	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Platelets, Grade 1	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Platelets, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Platelets, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities- Randomized Phase Platelets, Grade 4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 252

Population: Safety Population

Blood samples for assessment of hematology parameters were collected at indicated time points. Hematology assessments included hemoglobin, leukocytes, neutrophils and platelets. Data for number of participants who experienced maximum post-Baseline emergent hematology toxicities were summarized. Maximum post-Baseline emergent hematology toxicities were graded using DAIDS toxicity grading for HIV-infected participants as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (potentially life-threating). Higher grade indicates more severity.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Hemoglobin, Grade 1	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Hemoglobin, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Hemoglobin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Hemoglobin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Leukocytes, Grade 1	5 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Leukocytes, Grade 2	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Leukocytes, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Leukocytes, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Neutrophils, Grade 1	4 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Neutrophils, Grade 2	5 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Neutrophils, Grade 3	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Neutrophils, Grade 4	2 Participants	3 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Platelets, Grade 1	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Platelets, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Platelets, Grade 3	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline-emergent Hematology Toxicities - Randomized Phase + OLE Phase Platelets, Grade 4	0 Participants	0 Participants

SECONDARY outcome

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

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented as n=X in the category titles). Data for this outcome measure has been presented until Week 48 only (Randomized Phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase.

Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameters assessed during the lipid profile were total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, triglycerides. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Percent change from Baseline for a parameter was calculated as the observed value minus the Baseline value divided by Baseline value multiplied by 100. Data for fasting lipid parameters has been summarized.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 Cholesterol, Week 24, n=58, 40	6.314 Percent change Standard Deviation 20.7036	16.443 Percent change Standard Deviation 22.0445
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 Cholesterol, Week 48, n=47, 34	-0.375 Percent change Standard Deviation 21.4890	17.371 Percent change Standard Deviation 20.6312
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 HDL Cholesterol, Week 24, n=58, 40	39.002 Percent change Standard Deviation 53.5060	39.174 Percent change Standard Deviation 49.1087
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 HDL Cholesterol, Week 48, n=47, 34	24.987 Percent change Standard Deviation 48.2471	45.423 Percent change Standard Deviation 52.9949
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 LDL Cholesterol, Week 24, n=58, 40	4.315 Percent change Standard Deviation 31.7095	13.487 Percent change Standard Deviation 36.2511
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 LDL Cholesterol, Week 48, n=47, 34	-2.957 Percent change Standard Deviation 31.9910	9.132 Percent change Standard Deviation 41.1942
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 Triglycerides, Week 24, n=58, 40	-22.744 Percent change Standard Deviation 33.4148	16.934 Percent change Standard Deviation 118.7319
Percent Change From Baseline in the Fasting Lipid Profile at Week 24 and Week 48 Triglycerides, Week 48, n=47, 34	-18.402 Percent change Standard Deviation 39.0227	13.175 Percent change Standard Deviation 57.0389

SECONDARY outcome

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

Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented as n=X in the category titles). Data for this outcome measure has been presented until Week 48 only (Randomized Phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase.

Samples for lipid measurements were obtained in a fasted state at Baseline, Week 24 and Week 48. The parameter assessed during the lipid profile was total cholesterol/HDL ratio. Baseline was defined as the last pre-treatment value observed (typically from Day 1 visit). Change from baseline for a parameter was calculated as the observed value minus the Baseline value.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 Total cholesterol/HDL ratio, Week 24, n=58, 40	-16.292 Ratio of total cholesterol to HDL Standard Deviation 22.7982	36.562 Ratio of total cholesterol to HDL Standard Deviation 315.0478
Change From Baseline in the Fasting Lipid Profile for Total Cholesterol/HDL Ratio at Week 24 and Week 48 Total cholesterol/HDL ratio, Week 48, n=47, 34	-11.949 Ratio of total cholesterol to HDL Standard Deviation 27.5044	-11.051 Ratio of total cholesterol to HDL Standard Deviation 28.3183

SECONDARY outcome

Timeframe: Up to Week 52

Population: Safety Population

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE over 52 weeks has been summarized.

Outcome measures

Measure	DTG 50 mg n=69 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=44 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - Randomized Phase	0 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: Week 52 to Week 252

Population: Safety OLE Population

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Data for percentage of participants who permanently discontinued study treatment due to any AE from Week 52 to Week 252 has been summarized.

Outcome measures

Measure	DTG 50 mg n=47 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=19 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Percentage of Participants Who Permanently Discontinued Study Treatment Due to AEs - OLE Phase	4 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Week 12

Population: Safety Population. Only those participants with data available at the specified time points were analyzed. Data for this outcome measure has been presented until Week 12 only (Randomized phase) as per protocol. It was not planned for OLE Phase, hence data was not collected for OLE Phase.

Participants were monitored for signs and symptoms of TB-assoc. IRIS. Participants with IRIS symptoms in any AE or HIV assoc. conditions were classified by Endpoint Adjudication Committee in following four categories: met criteria for TB-assoc. IRIS, possibly met criteria for TB-assoc. IRIS, suspected TB-assoc. IRIS but not possible to adjudicate and No TB associated IRIS. They were further graded from Grades 1 to 4 using DAIDS. Higher grade indicates more severity. The preliminary requirements to meet TB-assoc. IRIS criteria were diagnosis of TB and initial response to TB treatment (stabilized or improved condition of participant in presence of TB treatment before starting ART). The clinical criteria was onset of IRIS signs and symptoms related to TB should occur within first 3 months of starting, restarting or changing ART regimen for treatment failure. Number of participants who sent to the adjudication committee and analyzed were presented.

Outcome measures

Measure	DTG 50 mg n=9 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=12 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Met criteria for TB-assoc. IRIS, Grade 1	1 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Met criteria for TB-assoc. IRIS, Grade 2	2 Participants	3 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Met criteria for TB-assoc. IRIS, Grade 3	1 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Met criteria for TB-assoc. IRIS, Grade 4	0 Participants	1 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Possibly met criteria for TB-assoc. IRIS, Grade 1	0 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Possibly met criteria for TB-assoc. IRIS, Grade 2	0 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Possibly met criteria for TB-assoc. IRIS, Grade 3	0 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Possibly met criteria for TB-assoc. IRIS, Grade 4	0 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Suspected TB-assoc. IRIS unable to adjudicate, Grade 1	0 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Suspected TB-assoc. IRIS unable to adjudicate, Grade 2	0 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Suspected TB-assoc. IRIS unable to adjudicate, Grade 3	0 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) Suspected TB-assoc. IRIS unable to adjudicate, Grade 4	0 Participants	0 Participants
Number of Participants With Tuberculosis (TB) Associated (Assoc.) Immune Reconstitution Inflammatory Syndrome (IRIS) No TB associated IRIS	5 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Viral Genotypic Population comprised of all participants in the ITT-E Population with available on-treatment genotypic data at the time confirmed virologic withdrawal was met.

Whole venous blood samples were obtained from each participant until Week 52 for potential viral genotypic and phenotypic analyses. Genotypic and phenotypic testing was conducted for participants meeting confirmed virologic withdrawal criteria, i.e., confirmed HIV-1 RNA >=400 copies/milliliter from Week 24 onwards. Genotypic and phenotypic analyses was carried out by Monogram Biosciences using, but not limited to, their Standard Phenosense and GenoSure testing methods for protease (PRO), reverse transcriptase (RT), and integrase assays. Data for number of participants with treatment-emergent genotypic resistance mutations have been presented for the RT region on codons G190G, K101K, K103K, K65K, V106V and Y181Y.

Outcome measures

Measure	DTG 50 mg n=2 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=1 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With Treatment-emergent Genotypic Resistance G190G (wild type)	2 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance G190G/A	0 Participants	1 Participants
Number of Participants With Treatment-emergent Genotypic Resistance K101K (wild type)	2 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance K101K/E	0 Participants	1 Participants
Number of Participants With Treatment-emergent Genotypic Resistance K103K (wild type)	2 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance K103K/N	0 Participants	1 Participants
Number of Participants With Treatment-emergent Genotypic Resistance K65K (wild type)	2 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance K65R	0 Participants	1 Participants
Number of Participants With Treatment-emergent Genotypic Resistance V106V (wild type)	2 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance V106M	0 Participants	1 Participants
Number of Participants With Treatment-emergent Genotypic Resistance Y181Y (wild type)	2 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance Y181Y/C	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 52

Population: Viral Phenotypic Population comprised of all participants in the ITT-E Population with available on-treatment phenotypic resistance data at the time confirmed virologic withdrawal criteria was met. Only participants available at the specified time points were analyzed (represented by n=X in the category titles).

Phenotypic susceptibility to all licensed antiretroviral drugs, including DTG and EFV were determined using PhenoSense HIV assays from Monogram Inc. Clinical cutoffs or biological cutoffs by PhenoSense were used to define the phenotypic susceptibility of background treatment and were interpreted as fold change > clinical lower cut-off or biologic cut-off as resistance, fold change <=clinical lower cut-off or biologic cut-off as sensitive, and fold change > clinical higher cut-off as resistance, fold change <=clinical higher cut-off and > clinical lower cut-off as partially sensitive, and fold change <=clinical lower cut-off as sensitive. Data has been presented for participants with treatment-emergent phenotypic resistance.

Outcome measures

Measure	DTG 50 mg n=2 Participants Participants in this arm received DTG 50 milligrams (mg) tablet with or without food twice-daily with 2 Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Tuberculosis (TB) treatment including isoniazid, rifampicin (RIF), pyrazinamide, and ethambutol provided at standard doses by the National TB Control Program (NTP) under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through the end of the Randomized Phase up to Week 52. Participants continued receiving DTG 50 mg once daily during the open-label extension phase (OLE) until DTG became locally approved and commercially available to all participating countries (occurred up to Week 252).	EFV 600 mg n=1 Participants Participants in this arm received EFV 600 mg tablet administered without food plus 2 NRTIs (TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions) through the end of the Randomized Phase up to Week 52. All participants receiving EFV then left the study and transitioned to locally-available EFV, except for participants randomized to EFV in South Africa who completed 2 years within the OLE phase and transitioned to locally available EFV regimens or withdrew from study prior to transitioning to locally-available EFV.
Number of Participants With Treatment-emergent Phenotypic Resistance Abacavir, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Dolutegravir, Sensitive, n=1,1	1 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Dolutegravir, Partially sensitive, n=1,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Dolutegravir, Resistance, n=1,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Elvitegravir, Sensitive, n=1,1	1 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Elvitegravir, Resistance, n=1,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Raltegravir, Sensitive, n=1,1	1 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Raltegravir, Resistance, n=1,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Delavirdine, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Delavirdine, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Efavirenz, Sensitive, n=2,1	2 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Efavirenz, Resistance, n=2,1	0 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Etravirine, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Etravirine, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Etravirine, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Nevirapine, Sensitive, n=2,1	2 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Nevirapine, Resistance, n=2,1	0 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Rilpivirine, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Rilpivirine, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Abacavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Abacavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Didanosine, Sensitive, n=2,1	2 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Didanosine, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Didanosine, Resistance, n=2,1	0 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Emtricitabine, Sensitive, n=2,1	2 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Emtricitabine, Resistance, n=2,1	0 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Lamivudine, Sensitive, n=2,1	2 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Lamivudine, Resistance, n=2,1	0 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Stavudine, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Stavudine, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Tenofovir, Sensitive, n=2,1	2 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Tenofovir, Partially sensitive, n=2,1	0 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Tenofovir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Zidovudine, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Zidovudine, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Atazanavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Atazanavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Darunavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Darunavir, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Darunavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Fosamprenavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Fosamprenavir, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Fosamprenavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Indinavir,Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Indinavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Lopinavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Lopinavir, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Lopinavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Nelfinavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Nelfinavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Ritonavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Ritonavir, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Ritonavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Saquinavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Saquinavir, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Saquinavir, Resistance, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Tipranavir, Sensitive, n=2,1	2 Participants	1 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Tipranavir, Partially sensitive, n=2,1	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Tipranavir, Resistance, n=2,1	0 Participants	0 Participants

Adverse Events

DTG 50 mg- Randomized Phase

Serious events: 5 serious events

Other events: 38 other events

Deaths: 0 deaths

EFV 600 mg- Randomized Phase

Serious events: 5 serious events

Other events: 33 other events

Deaths: 0 deaths

DTG 50 mg- OLE Phase

Serious events: 5 serious events

Other events: 36 other events

Deaths: 1 deaths

EFV 600 mg- OLE Phase

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	DTG 50 mg- Randomized Phase n=69 participants at risk In randomized phase, participants received DTG 50 mg tablet with or without food twice-daily with 2 NRTIs, TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through 52 weeks.	EFV 600 mg- Randomized Phase n=44 participants at risk In randomized phase, participants received EFV 600 mg tablet administered without food plus 2 NRTIs, TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions through 52 weeks.	DTG 50 mg- OLE Phase n=47 participants at risk In OLE Phase, participants received DTG 50 mg tablet until DTG became locally approved and commercially available.	EFV 600 mg- OLE Phase n=19 participants at risk In OLE Phase, participants received EFV 600 mg tablet.
Infections and infestations Cellulitis	1.4% 1/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Immune reconstitution inflammatory syndrome associated tuberculosis	1.4% 1/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Pneumonia	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.3% 1/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Tuberculosis gastrointestinal	1.4% 1/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.3% 1/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Injury, poisoning and procedural complications Skin abrasion	1.4% 1/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Immune system disorders Immune reconstitution inflammatory syndrome	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.3% 1/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.3% 1/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Psychiatric disorders Suicidal ideation	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.3% 1/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Renal and urinary disorders Acute kidney injury	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.3% 1/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.4% 1/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Psoas abscess	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Pregnancy, puerperium and perinatal conditions Foetal death	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Nervous system disorders Headache	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Nervous system disorders Hypocalcaemic seizure	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Nervous system disorders Seizure	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Investigations Blood creatine phosphokinase increased	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Pregnancy, puerperium and perinatal conditions Ruptured ectopic pregnancy	1.4% 1/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.

Other adverse events

Measure	DTG 50 mg- Randomized Phase n=69 participants at risk In randomized phase, participants received DTG 50 mg tablet with or without food twice-daily with 2 NRTIs, TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions until 2 weeks after TB therapy was completed and then received DTG 50 mg once daily (with the same NRTI backbone) through 52 weeks.	EFV 600 mg- Randomized Phase n=44 participants at risk In randomized phase, participants received EFV 600 mg tablet administered without food plus 2 NRTIs, TB treatment including isoniazid, RIF, pyrazinamide, and ethambutol provided at standard doses by the NTP under program conditions through 52 weeks.	DTG 50 mg- OLE Phase n=47 participants at risk In OLE Phase, participants received DTG 50 mg tablet until DTG became locally approved and commercially available.	EFV 600 mg- OLE Phase n=19 participants at risk In OLE Phase, participants received EFV 600 mg tablet.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Gastrointestinal disorders Anal fissure	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Gastrointestinal disorders Enteritis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Gastrointestinal disorders Haemorrhoids	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Gastrointestinal disorders Oesophagitis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Nervous system disorders Somnolence	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	10.5% 2/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	10.5% 2/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Psychiatric disorders Depression	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Upper respiratory tract infection	7.2% 5/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	18.2% 8/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	25.5% 12/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	26.3% 5/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Lower respiratory tract infection	13.0% 9/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.8% 3/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	8.5% 4/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	15.8% 3/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Pharyngitis	7.2% 5/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.8% 3/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Gastroenteritis	1.4% 1/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	11.4% 5/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	10.5% 2/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Herpes zoster	4.3% 3/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.8% 3/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Body tinea	5.8% 4/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Nervous system disorders Headache	13.0% 9/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	13.6% 6/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	10.6% 5/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	21.1% 4/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Nervous system disorders Dizziness	4.3% 3/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	13.6% 6/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Gastrointestinal disorders Diarrhoea	4.3% 3/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	22.7% 10/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	8.5% 4/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	15.8% 3/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Gastrointestinal disorders Vomiting	7.2% 5/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.8% 3/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Gastrointestinal disorders Nausea	5.8% 4/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.8% 3/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Musculoskeletal and connective tissue disorders Arthralgia	10.1% 7/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Musculoskeletal and connective tissue disorders Back pain	7.2% 5/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Skin and subcutaneous tissue disorders Rash	5.8% 4/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.3% 1/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Psychiatric disorders Insomnia	2.9% 2/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.8% 3/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Respiratory, thoracic and mediastinal disorders Cough	2.9% 2/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.8% 3/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	4.3% 2/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Reproductive system and breast disorders Gynaecomastia	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	9.1% 4/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Furuncle	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	10.5% 2/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Urinary tract infection	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	8.5% 4/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Bronchitis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Influenza	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Nasopharyngitis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	4.3% 2/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Acarodermatitis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Fungal skin infection	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Tonsillitis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Conjunctivitis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Cystitis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Pulmonary tuberculosis	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Tinea faciei	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Tuberculosis gastrointestinal	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Infections and infestations Varicella zoster virus infection	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Gastrointestinal disorders Peptic ulcer	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
General disorders Mass	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
General disorders Non-cardiac chest pain	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Renal and urinary disorders Dysuria	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	10.5% 2/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	8.5% 4/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Blood and lymphatic system disorders Neutropenia	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	4.3% 2/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	2.1% 1/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Investigations Blood creatinine increased	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.4% 3/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Investigations Blood pressure increased	5.8% 4/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	4.3% 2/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	5.3% 1/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.
Investigations Alanine aminotransferase increased	0.00% 0/69 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	6.8% 3/44 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/47 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.	0.00% 0/19 • Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase and from Week 52 to Week 252 for OLE Phase. Safety Population was used to assess SAEs and non-SAEs for Randomized Phase which comprised of all participants who received at least one dose of IP. Safety OLE Population was used to assess SAEs and non-SAEs for OLE Phase which comprised of all participants in Safety Population who entered the OLE phase. AEs were presented treatment-wise and phase-wise.

Additional Information

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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