<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02227238</url>
  </required_header>
  <id_info>
    <org_study_id>200304</org_study_id>
    <secondary_id>2014-001057-17</secondary_id>
    <nct_id>NCT02227238</nct_id>
  </id_info>
  <brief_title>Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment</brief_title>
  <official_title>A Phase 3b, Randomized, Open-label Study of the Antiviral Activity and Safety of Dolutegravir Compared to Lopinavir/Ritonavir Both Administered With Dual Nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1 Infected Adult Subjects With Treatment Failure on First Line Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ViiV Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>ViiV Healthcare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend&#xD;
      to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse&#xD;
      transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase inhibitors&#xD;
      (NRTIs) for first-line antiretroviral therapy (ART); however, there is a need for further&#xD;
      data on the best treatment options for people with HIV-1 who have virological failure with&#xD;
      this first-line regimen. The number of patients failing on their first-line regimen is&#xD;
      increasing thereby requiring a switch to second-line treatment to reduce accumulation of&#xD;
      drug-resistance mutations, disease progression, HIV transmission, and death. WHO guidelines&#xD;
      recommend second-line antiretroviral therapy for adults consisting of two NRTIs + a&#xD;
      ritonavir-boosted protease inhibitor (PI); atazanavir (ATV) plus ritonavir (RTV) or lopinavir&#xD;
      (LPV)/RTV are the preferred boosted PI options. This study is conducted to demonstrate&#xD;
      non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen&#xD;
      compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV +&#xD;
      two NRTIs, in HIV-1 infected patients failing first line therapy. This study comprises of a&#xD;
      Screening Phase (approximately 28 to 42 days), a Randomized Phase (Day 1 to Week 48 plus a&#xD;
      4-week treatment extension), and a Continuation Phase. Approximately 612 subjects will be&#xD;
      randomized 1:1 to receive DTG 50 milligram (mg) once daily or LPV/RTV (800/200 mg once daily&#xD;
      or 400/100 mg twice daily, in accordance with investigator decision and local label), each&#xD;
      added to an investigator selected background regimen of two NRTIs at least one of which needs&#xD;
      to be fully active based on viral resistance testing at Screening. Subjects randomized to the&#xD;
      LPV/RTV arm will either (i) continue receiving LPV/RTV and complete the study after the&#xD;
      4-week treatment extension at Week 52, or (ii) switch to the DTG arm prior to study&#xD;
      completion at Week 52 and continue to have access to DTG in the Continuation Phase. Subjects&#xD;
      randomized to receive DTG who successfully complete 52 weeks of treatment and subjects&#xD;
      originally randomized to receive LPV/RTV but switched to DTG prior to Week 52 will continue&#xD;
      to have access to DTG until it is either locally approved and commercial supplies are&#xD;
      available to patients or the patient no longer derives clinical benefit, or the patient meets&#xD;
      a protocol-defined reason for discontinuation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2014</start_date>
  <completion_date type="Actual">February 14, 2022</completion_date>
  <primary_completion_date type="Actual">August 2, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) &lt;50 Copies Per Milliliter (c/mL) at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Percentage of participants with plasma HIV 1 RNA &lt;50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Plasma HIV-1 RNA &lt;50 c/mL at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>Percentage of participants with plasma HIV 1 RNA &lt;50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Percentage values are rounded off.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Plasma HIV-1 RNA &lt;400 c/mL at Weeks 24 and 48</measure>
    <time_frame>Week 24 and Week 48</time_frame>
    <description>Percentage of participants with plasma HIV 1 RNA &lt;400 c/mL at Week 24 and 48 using the FDA snapshot algorithm were evaluated. Percentage values are rounded off.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48</measure>
    <time_frame>Week 24 and Week 48</time_frame>
    <description>Virologic or tolerability failure was defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy). Percentage of participants without virologic failure by Week 24 and Week 48 have been presented. Participants who did not met the protocol defined confirmed virologic withdrawal criteria and are ongoing in the study, or who had discontinued for non-treatment related reasons were censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Viral Suppression at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>Viral suppression was defined as HIV-1 RNA &lt;50 c/mL. Time to viral suppression was analyzed and median and interquartile range has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 24 and Week 48</time_frame>
    <description>Blood was collected and CD4+ cell count assessment was carried out at indicated time points to evaluate the immunological activity of DTG compared to LPV/RTV. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Disease Progression-Randomized + Continuation Phase</measure>
    <time_frame>Up to Week 348</time_frame>
    <description>Disease progression included HIV-associated conditions, acquired immune deficiency syndrome (AIDS) and death. Number of participants with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of participants, who met confirmed virologic withdrawal (CVW) criteria with paired Baseline and time of CVW resistance data with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Viral Genotypic Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met during Randomized Phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase</measure>
    <time_frame>Up to Week 295</time_frame>
    <description>Number of participants, who met confirmed virologic withdrawal criteria with paired Baseline and time of CVW resistance data, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Analysis was performed on Viral Genotypic Continuation Population which comprised all participants in the ITT-E- Continuation Population with available on-treatment genotypic resistance data in the Continuation Phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase</measure>
    <time_frame>Baseline (Day 1, Pre-dose) and up to Week 52</time_frame>
    <description>Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG, LPV/RTV was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to &gt;2 from Baseline is presented. Analysis was performed on viral phenotypic Population, which comprised of all participants in the ITT-E Population with available On-treatment phenotypic resistance data at the time confirmed virologic withdrawal criterion is met during Randomized Phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase</measure>
    <time_frame>Baseline (Day 1, Pre-dose) and up to Week 295</time_frame>
    <description>Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to &gt;2 from Baseline is presented. Analysis was performed on Viral Phenotypic Continuation Population which comprises all participants in the ITT-E- Continuation Population with available on-treatment phenotypic resistance data in the Continuation Phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-serious Adverse Events (AEs) With &gt;=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Adverse events which were not Serious were considered as Non-Serious adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-serious AEs With &gt;=2% Frequency Threshold and SAEs-Continuation Phase</measure>
    <time_frame>Up to Week 295</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Non-serious AEs With &gt;=2% Frequency Threshold and SAEs-Randomized + Continuation Phase</measure>
    <time_frame>Up to Week 348</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, chloride, carbon-di-oxide (CO2), potassium, phosphate, sodium, urea, cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Lipid parameters were evaluated in fasting condition. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, ALT, AST and creatine kinase. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Albumin Values</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameter including albumin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Creatinine and Bilirubin Values</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine and bilirubin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Lipase Values</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical chemistry parameter including lipase. Change from Baseline in lipase at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Chemistry Toxicities -Randomized Phase</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Chemistry Toxicities-Continuation Phase</measure>
    <time_frame>Up to Week 295</time_frame>
    <description>Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hematocrit Values</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameter including hematocrit. Change from Baseline in hematocrit values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hemoglobin Values</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameter including hemoglobin. Change from Baseline in hemoglobin values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Mean Corpuscular Volume (MCV)</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameter including MCV. Change from Baseline in MCV values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Erythrocyte Values</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and up to Week 52</time_frame>
    <description>Blood samples were collected from participants to evaluate clinical hematology parameter including erythrocyte. Change from Baseline in erythrocyte values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hematology Toxicities -Randomized Phase</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hematology Toxicities-Continuation Phase</measure>
    <time_frame>Up to Week 295</time_frame>
    <description>Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Number of participants who discontinued study treatment due to AEs or SAEs were summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Discontinued Treatment Due to AEs-Continuation Phase</measure>
    <time_frame>Up to Week 295</time_frame>
    <description>Number of participants who discontinued study treatment due to AEs were summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 24 and Week 48</time_frame>
    <description>Blood samples were collected from participants in fasting state to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Analysis was performed using multiple imputation with missing at random assumption. Only participants available at the time of evaluation were analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 24 and Week 48</time_frame>
    <description>Blood samples were collected from participants in fasting state to evaluate total cholesterol/HDL cholesterol ratio. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only participants available at the time of evaluation were analyzed. Analysis was performed using multiple imputation with missing at random assumption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Blood samples were collected from participants in fasting state at indicated time-points to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in fasting LDL cholesterol was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea</measure>
    <time_frame>Week 24 and Week 48</time_frame>
    <description>Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in drug-related diarrhea was summarized. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48</time_frame>
    <description>The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The scale ranges from 1= no discomfort to 7= very severe discomfort for each symptom cluster. Higher scores show greater severity of symptoms. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using Last Observation Carried Forward (LOCF) dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48</time_frame>
    <description>The HIVTSQ is a self-reported scales that measure overall satisfaction with treatment. The score ranges from 0-10. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8)</measure>
    <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 24 and Week 48</time_frame>
    <description>Treatment compliance was evaluated through MMAS-8. It is an eight-item self-reported measure of medication-taking behavior. The score ranges from 0-8 where scores of 8 indicate high or near perfect adherence, and scores of less than 6 indicate poor or inadequate adherence on the MMAS-8 scale. Number of participants showing low, medium and high adherence to treatment are presented. Low adherence is a score 0-5.75, medium adherence is a score of 6-7.75 and high adherence is a score of 8. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">627</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>DTG arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive one oral tablet of 50 mg DTG once daily plus two NRTIs selected by the investigator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LPV/RTV arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive four oral tablets of200/50 mg LPV/RTV once daily or two oral tablets of 200/50 mg LPV/RTV twice daily plus two NRTIs selected by the investigator</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DTG</intervention_name>
    <description>DTG is supplied as 50 mg tablets</description>
    <arm_group_label>DTG arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LPV/RTV</intervention_name>
    <description>LPV/RTV is supplied as the LPV/RTV oral tablet, which contains 200 mg of LPV and 50 mg of RTV</description>
    <arm_group_label>LPV/RTV arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Two NRTIs</intervention_name>
    <description>Investigators will choose a dual NRTI background regimen for each subject . In consultation with the medical monitor, 3TC may be added as a third NRTI to a dual-NRTI background regimen in subjects with chronic HBV infection and evidence of HIV resistance to 3TC</description>
    <arm_group_label>DTG arm</arm_group_label>
    <arm_group_label>LPV/RTV arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HIV-1 infected subjects &gt;=18 years of age.&#xD;
&#xD;
          -  A female subject may be eligible to enter and participate in the study if she:&#xD;
&#xD;
        is of non-childbearing potential defined as either post-menopausal (12 months of&#xD;
        spontaneous amenorrhea and &gt;=45 years of age) or physically incapable of becoming pregnant&#xD;
        with documented tubal ligation, hysterectomy, or bilateral oophorectomy or, is of&#xD;
        child-bearing potential, with a negative pregnancy test at both Screening and Day 1 and&#xD;
        agrees to use one of the protocol-defined methods of contraception to avoid pregnancy&#xD;
        throughout the study and for at least 2 weeks after discontinuation of all study&#xD;
        medication.&#xD;
&#xD;
          -  HIV-1 infection as documented by HIV-1 RNA &gt;=400 c/mL at Screening.&#xD;
&#xD;
          -  Subject has been on a first-line treatment regimen consisting of an NNRTI plus two&#xD;
             NRTIs for at least 6 months and is currently experiencing virologic failure to this&#xD;
             first-line regimen defined as two consecutive (&gt;=7 days apart) HIV-1 RNA results of&#xD;
             &gt;=400 c/mL.&#xD;
&#xD;
          -  Subjects must receive at least one fully active agent within the dual-NRTI background&#xD;
             regimen for second line treatment. Fully active is defined by the Screening genotypic&#xD;
             resistance report of the central laboratory (or a laboratory contracted by the central&#xD;
             laboratory) showing no evidence of full or of partial resistance for a given NRTI&#xD;
             which will be taken on study.&#xD;
&#xD;
          -  Subject is PI-naïve and Integrase inhibitor (INI)-naïve, defined as no prior or&#xD;
             current exposure to any PI or INI.&#xD;
&#xD;
          -  Subject or the subject's legal representative is willing and able to understand and&#xD;
             provide signed and dated written informed consent prior to screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are breastfeeding.&#xD;
&#xD;
          -  Any evidence of an active Centers for Disease Control and Prevention (CDC) Category C&#xD;
             disease Exceptions include cutaneous Kaposi's sarcoma not requiring systemic therapy&#xD;
             and historic or current CD4+ cell levels &lt;200 cells per cubic millimeter&#xD;
&#xD;
          -  Subjects with severe hepatic impairment (Class C) as determined by Child-Pugh&#xD;
             classification&#xD;
&#xD;
          -  Unstable liver disease (as defined by the presence of ascites, encephalopathy,&#xD;
             coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent&#xD;
             jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's&#xD;
             syndrome or asymptomatic gallstones).&#xD;
&#xD;
          -  Anticipated need for hepatitis C virus (HCV) therapy during the Randomized Phase of&#xD;
             the study.&#xD;
&#xD;
          -  History or presence of allergy or intolerance to the study drugs or their components&#xD;
             or drugs of their class.&#xD;
&#xD;
          -  Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or&#xD;
             resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial&#xD;
             neoplasia; other localized malignancies require agreement between the investigator and&#xD;
             the Study medical monitor for inclusion of the subject.&#xD;
&#xD;
          -  Subjects who in the investigator's judgment, poses a significant suicidality risk.&#xD;
             Recent history of suicidal behavior and/or suicidal ideation may be considered as&#xD;
             evidence of serious suicide risk.&#xD;
&#xD;
          -  Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.&#xD;
&#xD;
          -  Treatment with any of the following agents within 28 days of Screening: radiation&#xD;
             therapy, cytotoxic chemotherapeutic agents, systemically administered&#xD;
             immunomodulators.&#xD;
&#xD;
          -  Treatment with any agent, other than licensed ART as allowed above with documented&#xD;
             activity against HIV-1 in vitro/vivo within 28 days of first dose of IP. The exception&#xD;
             is use of entecavir, in appropriate clinical situations, for treatment of hepatitis B&#xD;
             [e.g. prior intolerance to Tenofovir (TDF), viral resistance to lamivudine (3TC) /&#xD;
             Emtricitabine (FTC)] after discussion and agreement between the investigator and the&#xD;
             medical monitor.&#xD;
&#xD;
          -  Exposure to an experimental drug or experimental vaccine within either 28 days, 5&#xD;
             half-lives of the test agent, or twice the duration of the biological effect of the&#xD;
             test agent, whichever is longer, prior to the first dose of IP.&#xD;
&#xD;
          -  Any evidence of primary viral resistance to PIs or INIs based on the presence of any&#xD;
             major resistance-associated mutation.&#xD;
&#xD;
          -  The subject's virus does not yield results using genotype at Screening (assay data is&#xD;
             essential for eligibility determination).&#xD;
&#xD;
          -  Any verified Grade 4 laboratory abnormality, with the exception of Grade 4&#xD;
             triglycerides. A single repeat test is allowed during the Screening period to verify a&#xD;
             result.&#xD;
&#xD;
          -  Any acute laboratory abnormality at Screening, which, in the opinion of the&#xD;
             Investigator, would preclude the subject's participation in the study of an&#xD;
             investigational compound.&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) &gt;=5 times the upper limit of normal (ULN) or ALT&#xD;
             &gt;=3xULN and bilirubin &gt;=1.5xULN (with &gt;35% direct bilirubin)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>ViiV Healthcare</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1405CKC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1202ABB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1141</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1221ADC</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autónoma de Buenos Aires</city>
        <zip>C1426ABP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Córdoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salvador</city>
        <state>Bahía</state>
        <zip>40110-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <zip>01246-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21045900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>São Paulo</city>
        <zip>04121-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Puente Alto - Santiago</city>
        <state>Región Metro De Santiago</state>
        <zip>8207257</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santiago</city>
        <state>Región Metro De Santiago</state>
        <zip>8330074</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santiago</city>
        <state>Región Metro De Santiago</state>
        <zip>8900088</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santiago</city>
        <zip>8360159</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <zip>100015</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <zip>201508</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bogota</city>
        <zip>111311</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bogota</city>
        <zip>5600520</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nairobi</city>
        <zip>00100</zip>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44280</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Distrito Federal</city>
        <zip>06470</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mexico City</city>
        <zip>03720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mexico</city>
        <zip>14000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Callao</city>
        <zip>Callao 02</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>1</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>32</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lima</city>
        <zip>Lima 31</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>021105</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>030303</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400348</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Constanta</city>
        <zip>900708</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Targu Mures</city>
        <zip>540394</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barnaul</city>
        <zip>656010</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620149</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kazan</city>
        <zip>420061</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kemerovo</city>
        <zip>650056</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krasnodar</city>
        <zip>350015</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>105275</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Smolensk</city>
        <zip>214006</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>190103</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toliyatti</city>
        <zip>445846</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Soweto</city>
        <state>Gauteng</state>
        <zip>2013</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bloemfontein</city>
        <zip>9301</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Durban</city>
        <zip>4001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Observatory, Cape Town</city>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Westdene</city>
        <zip>2092</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nonthaburi</city>
        <zip>11000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ratchatewi</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Odessa</city>
        <zip>65031</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21021</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zaporizhzhya</city>
        <zip>69006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Chile</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Kenya</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Thailand</country>
    <country>Ukraine</country>
  </location_countries>
  <reference>
    <citation>Aboud M, Kaplan R, Lombaard J, Zhang F, Hidalgo JA, Mamedova E, Losso MH, Chetchotisakd P, Brites C, Sievers J, Brown D, Hopking J, Underwood M, Nascimento MC, Punekar Y, Gartland M, Smith K. Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy in adults with HIV-1 infection in whom first-line therapy has failed (DAWNING): an open-label, non-inferiority, phase 3b trial. Lancet Infect Dis. 2019 Mar;19(3):253-264. doi: 10.1016/S1473-3099(19)30036-2. Epub 2019 Feb 4.</citation>
    <PMID>30732940</PMID>
  </reference>
  <reference>
    <citation>Underwood M, Horton J, Nangle K, Hopking J, Smith K, Aboud M, Wynne B, Sievers J, Stewart EL, Wang R. Integrase Inhibitor Resistance Mechanisms and Structural Characteristics in Antiretroviral Therapy-Experienced, Integrase Inhibitor-Naive Adults with HIV-1 Infection Treated with Dolutegravir plus Two Nucleoside Reverse Transcriptase Inhibitors in the DAWNING Study. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0164321. doi: 10.1128/AAC.01643-21. Epub 2021 Oct 25. Erratum In: Antimicrob Agents Chemother. 2023 Mar 16;67(3):e0032622.</citation>
    <PMID>34694877</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>July 25, 2018</results_first_submitted>
  <results_first_submitted_qc>April 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 12, 2019</results_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>integrase inhibitor</keyword>
  <keyword>non-inferiority</keyword>
  <keyword>dolutegravir</keyword>
  <keyword>lopinavir/ritonavir</keyword>
  <keyword>second-line treatment</keyword>
  <keyword>HIV-1</keyword>
  <keyword>antiretroviral therapy-experienced</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.</ipd_time_frame>
    <ipd_access_criteria>Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.</ipd_access_criteria>
    <ipd_url>https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02227238/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 31, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02227238/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study assessed antiviral activity and safety of dolutegravir (DTG) in human immunodeficiency virus-1 (HIV-1) infected participants with treatment failure on first line therapy. The study consisted of Randomized Phase followed by Continuation Phase.</recruitment_details>
      <pre_assignment_details>A total of 627 participants were randomized in 1:1 to receive DTG or lopinavir/ritonavir (LPV/RTV). Three participants in the LPV/RTV group were randomized but not treated. A total of 624 participants received at least one dose of study medication creating the intent to treat-exposed (ITT-E) Population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Participants Receiving DTG-Randomized Phase</title>
          <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
        </group>
        <group group_id="P2">
          <title>Participants Receiving LPV/RTV-Randomized Phase</title>
          <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
        </group>
        <group group_id="P3">
          <title>Participants Receiving DTG-Continuation Phase</title>
          <description>Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomized Phase (Up to Week 52)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="312"/>
                <participants group_id="P2" count="315"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ITT-E Population</title>
              <participants_list>
                <participants group_id="P1" count="312"/>
                <participants group_id="P2" count="312"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="275"/>
                <participants group_id="P2" count="245"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="70"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Reached stopping criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized, but did not receive treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Continuation Phase(From Weeks 52 to 295)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="274">274 participants from the Randomized entered in the Continuation Phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="225"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="49"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline Characteristic data are reported for members of the ITT-E Population which comprised of all participants who received at least one dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Participants Receiving DTG-Randomized Phase</title>
          <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
        </group>
        <group group_id="B2">
          <title>Participants Receiving LPV/RTV-Randomized Phase</title>
          <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="312"/>
            <count group_id="B2" value="312"/>
            <count group_id="B3" value="624"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.5" spread="9.13"/>
                    <measurement group_id="B2" value="38.7" spread="9.35"/>
                    <measurement group_id="B3" value="38.1" spread="9.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="219"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="196"/>
                    <measurement group_id="B2" value="209"/>
                    <measurement group_id="B3" value="405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race, customized</title>
              <category_list>
                <category>
                  <title>American Indian or Alaska native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian- Central/South Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian - East Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian - South East Asian Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White - Arabic/North African Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White - White/Caucasian/European Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="178"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed White Race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American Heritage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="112"/>
                    <measurement group_id="B3" value="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) &lt;50 Copies Per Milliliter (c/mL) at Week 48</title>
        <description>Percentage of participants with plasma HIV 1 RNA &lt;50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.</description>
        <time_frame>Week 48</time_frame>
        <population>ITT-E Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) &lt;50 Copies Per Milliliter (c/mL) at Week 48</title>
          <description>Percentage of participants with plasma HIV 1 RNA &lt;50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.</description>
          <population>ITT-E Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority of DTG plus 2 NRTI's was to be declared if the lower bound of 95% confidence interval (CI) for the difference in snapshot response rates (DTG - LPV/RTV) is greater than - 12%. This was also performed using the Per-Protocol (PP) Population. If both analyses show non-inferiority, the hypothesis of antiviral effect of DTG + 2 NRTI's was superior to LPV/RTV + 2 NRTIs was to be tested.</non_inferiority_desc>
            <p_value>&lt;.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Proportion difference</param_type>
            <param_value>13.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.3</ci_lower_limit>
            <ci_upper_limit>20.3</ci_upper_limit>
            <estimate_desc>Adjusted proportion difference, calculated as proportion on DTG minus that on LPV/RTV and based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline plasma HIV-1 RNA and number of fully active background NRTIs, has been presented.</estimate_desc>
            <other_analysis_desc>Superiority would be declared if the lower end of the confidence interval was above 0%</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Plasma HIV-1 RNA &lt;50 c/mL at Week 24</title>
        <description>Percentage of participants with plasma HIV 1 RNA &lt;50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Percentage values are rounded off.</description>
        <time_frame>Week 24</time_frame>
        <population>ITT-E Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Plasma HIV-1 RNA &lt;50 c/mL at Week 24</title>
          <description>Percentage of participants with plasma HIV 1 RNA &lt;50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Percentage values are rounded off.</description>
          <population>ITT-E Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Plasma HIV-1 RNA &lt;400 c/mL at Weeks 24 and 48</title>
        <description>Percentage of participants with plasma HIV 1 RNA &lt;400 c/mL at Week 24 and 48 using the FDA snapshot algorithm were evaluated. Percentage values are rounded off.</description>
        <time_frame>Week 24 and Week 48</time_frame>
        <population>ITT-E Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Plasma HIV-1 RNA &lt;400 c/mL at Weeks 24 and 48</title>
          <description>Percentage of participants with plasma HIV 1 RNA &lt;400 c/mL at Week 24 and 48 using the FDA snapshot algorithm were evaluated. Percentage values are rounded off.</description>
          <population>ITT-E Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48</title>
        <description>Virologic or tolerability failure was defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy). Percentage of participants without virologic failure by Week 24 and Week 48 have been presented. Participants who did not met the protocol defined confirmed virologic withdrawal criteria and are ongoing in the study, or who had discontinued for non-treatment related reasons were censored.</description>
        <time_frame>Week 24 and Week 48</time_frame>
        <population>ITT-E Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48</title>
          <description>Virologic or tolerability failure was defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy). Percentage of participants without virologic failure by Week 24 and Week 48 have been presented. Participants who did not met the protocol defined confirmed virologic withdrawal criteria and are ongoing in the study, or who had discontinued for non-treatment related reasons were censored.</description>
          <population>ITT-E Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6"/>
                    <measurement group_id="O2" value="91.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0"/>
                    <measurement group_id="O2" value="86.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Proportion difference</param_type>
            <param_value>5.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.2</ci_lower_limit>
            <ci_upper_limit>9.3</ci_upper_limit>
            <estimate_desc>Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 24 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Proportion difference</param_type>
            <param_value>9.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.3</ci_lower_limit>
            <ci_upper_limit>14.4</ci_upper_limit>
            <estimate_desc>Proportion difference, calculated as proportion on DTG minus proportion on LPV/RTV, at Week 48 has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Viral Suppression at Week 48</title>
        <description>Viral suppression was defined as HIV-1 RNA &lt;50 c/mL. Time to viral suppression was analyzed and median and interquartile range has been presented.</description>
        <time_frame>Week 48</time_frame>
        <population>ITT-E Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Viral Suppression at Week 48</title>
          <description>Viral suppression was defined as HIV-1 RNA &lt;50 c/mL. Time to viral suppression was analyzed and median and interquartile range has been presented.</description>
          <population>ITT-E Population</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.0" lower_limit="29.0" upper_limit="57.0"/>
                    <measurement group_id="O2" value="111.0" lower_limit="35.0" upper_limit="167.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48</title>
        <description>Blood was collected and CD4+ cell count assessment was carried out at indicated time points to evaluate the immunological activity of DTG compared to LPV/RTV. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 24 and Week 48</time_frame>
        <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).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48</title>
          <description>Blood was collected and CD4+ cell count assessment was carried out at indicated time points to evaluate the immunological activity of DTG compared to LPV/RTV. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value.</description>
          <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).</population>
          <units>Cells per cubic millimeter (Cells/mm^3)</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24; n= 291, 285</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                    <count group_id="O2" value="285"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.0" lower_limit="31.0" upper_limit="146.0"/>
                    <measurement group_id="O2" value="82.0" lower_limit="31.0" upper_limit="146.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n= 275, 251</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="275"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.0" lower_limit="63.0" upper_limit="204.0"/>
                    <measurement group_id="O2" value="118.0" lower_limit="66.0" upper_limit="191.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Disease Progression-Randomized + Continuation Phase</title>
        <description>Disease progression included HIV-associated conditions, acquired immune deficiency syndrome (AIDS) and death. Number of participants with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.</description>
        <time_frame>Up to Week 348</time_frame>
        <population>ITT-E Population</population>
        <group_list>
          <group group_id="O1">
            <title>DTG in Randomized Phase Followed by Continuation Phase</title>
            <description>Participants received 1 tablet of 50 mg of DTG once daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants who completed 52 weeks of treatment, continued to receive DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
          </group>
          <group group_id="O2">
            <title>LPV/RTV-Randomized Phase Followed by DTG in Continuation Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants switched to DTG by Week 52 continued to receive DTG in Continuation Phase until it was either locally approved and commercial supplies were available.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Disease Progression-Randomized + Continuation Phase</title>
          <description>Disease progression included HIV-associated conditions, acquired immune deficiency syndrome (AIDS) and death. Number of participants with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.</description>
          <population>ITT-E Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase</title>
        <description>Number of participants, who met confirmed virologic withdrawal (CVW) criteria with paired Baseline and time of CVW resistance data with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Viral Genotypic Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met during Randomized Phase.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>Viral genotypic Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase</title>
          <description>Number of participants, who met confirmed virologic withdrawal (CVW) criteria with paired Baseline and time of CVW resistance data with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Viral Genotypic Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met during Randomized Phase.</description>
          <population>Viral genotypic Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>INSTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase</title>
        <description>Number of participants, who met confirmed virologic withdrawal criteria with paired Baseline and time of CVW resistance data, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Analysis was performed on Viral Genotypic Continuation Population which comprised all participants in the ITT-E- Continuation Population with available on-treatment genotypic resistance data in the Continuation Phase.</description>
        <time_frame>Up to Week 295</time_frame>
        <population>Viral genotypic continuation Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Continuation Phase</title>
            <description>Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase</title>
          <description>Number of participants, who met confirmed virologic withdrawal criteria with paired Baseline and time of CVW resistance data, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Analysis was performed on Viral Genotypic Continuation Population which comprised all participants in the ITT-E- Continuation Population with available on-treatment genotypic resistance data in the Continuation Phase.</description>
          <population>Viral genotypic continuation Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>INSTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRTI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase</title>
        <description>Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG, LPV/RTV was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to &gt;2 from Baseline is presented. Analysis was performed on viral phenotypic Population, which comprised of all participants in the ITT-E Population with available On-treatment phenotypic resistance data at the time confirmed virologic withdrawal criterion is met during Randomized Phase.</description>
        <time_frame>Baseline (Day 1, Pre-dose) and up to Week 52</time_frame>
        <population>Viral Phenotypic Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase</title>
          <description>Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG, LPV/RTV was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to &gt;2 from Baseline is presented. Analysis was performed on viral phenotypic Population, which comprised of all participants in the ITT-E Population with available On-treatment phenotypic resistance data at the time confirmed virologic withdrawal criterion is met during Randomized Phase.</description>
          <population>Viral Phenotypic Population. Only those participants with data available at specified time point were analyzed (represented by n=X) in category titles.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DTG; &lt;1; n=11, 23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG; 1-&lt;2; n=11, 23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG; 2-&lt;4; n=11, 23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG; 4-&lt;8; n=11, 23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG; &gt;=8; n=11, 23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV/RTV; &lt;1; n=11, 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV/RTV; 1-&lt;2; n=11, 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV/RTV; 2-&lt;4; n=11, 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV/RTV; 4-&lt;8; n=11, 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LPV/RTV; &gt;=8; n=11, 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase</title>
        <description>Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to &gt;2 from Baseline is presented. Analysis was performed on Viral Phenotypic Continuation Population which comprises all participants in the ITT-E- Continuation Population with available on-treatment phenotypic resistance data in the Continuation Phase.</description>
        <time_frame>Baseline (Day 1, Pre-dose) and up to Week 295</time_frame>
        <population>Viral Phenotypic continuation Population. Only those participants with data available at specified time point were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG in Continuation Phase</title>
            <description>Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase</title>
          <description>Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to &gt;2 from Baseline is presented. Analysis was performed on Viral Phenotypic Continuation Population which comprises all participants in the ITT-E- Continuation Population with available on-treatment phenotypic resistance data in the Continuation Phase.</description>
          <population>Viral Phenotypic continuation Population. Only those participants with data available at specified time point were analyzed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DTG; &lt;1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG; 1-&lt;2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG; 2-&lt;4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG; 4-&lt;8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG; &gt;=8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-serious Adverse Events (AEs) With &gt;=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase</title>
        <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Adverse events which were not Serious were considered as Non-Serious adverse events.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-serious Adverse Events (AEs) With &gt;=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase</title>
          <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Adverse events which were not Serious were considered as Non-Serious adverse events.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                    <measurement group_id="O2" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-serious AEs With &gt;=2% Frequency Threshold and SAEs-Continuation Phase</title>
        <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.</description>
        <time_frame>Up to Week 295</time_frame>
        <population>Safety-Continuation Population comprised all participants in the Safety Population who received at least one dose of Investigational Product after entering the Continuation Phase.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Continuation Phase</title>
            <description>Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-serious AEs With &gt;=2% Frequency Threshold and SAEs-Continuation Phase</title>
          <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.</description>
          <population>Safety-Continuation Population comprised all participants in the Safety Population who received at least one dose of Investigational Product after entering the Continuation Phase.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Non-serious AEs With &gt;=2% Frequency Threshold and SAEs-Randomized + Continuation Phase</title>
        <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.</description>
        <time_frame>Up to Week 348</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>DTG- Randomized Phase Followed by Continuation Phase</title>
            <description>Participants received 1 tablet of 50 mg of DTG once daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants who completed 52 weeks of treatment, continued to receive DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
          </group>
          <group group_id="O2">
            <title>LPV/RTV- Randomized Phase Followed by DTG-Continuation Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants switched to DTG by Week 52 continued to receive DTG in Continuation Phase until it was either locally approved and commercial supplies were available.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Non-serious AEs With &gt;=2% Frequency Threshold and SAEs-Randomized + Continuation Phase</title>
          <description>An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any non-serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="218"/>
                    <measurement group_id="O2" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, chloride, carbon-di-oxide (CO2), potassium, phosphate, sodium, urea, cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Lipid parameters were evaluated in fasting condition. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, chloride, carbon-di-oxide (CO2), potassium, phosphate, sodium, urea, cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Lipid parameters were evaluated in fasting condition. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Millimoles per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Glucose; Week 4; n= 279, 277</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="279"/>
                    <count group_id="O2" value="277"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.789"/>
                    <measurement group_id="O2" value="0.01" spread="0.661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; Week 8; n= 273, 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="273"/>
                    <count group_id="O2" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="1.086"/>
                    <measurement group_id="O2" value="-0.00" spread="0.914"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; Week 16; n= 280, 275</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.740"/>
                    <measurement group_id="O2" value="-0.06" spread="1.060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; Week 24; n= 288, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="288"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="2.286"/>
                    <measurement group_id="O2" value="-0.04" spread="1.037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; Week 36; n= 270, 257</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="270"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="1.056"/>
                    <measurement group_id="O2" value="-0.01" spread="1.176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; Week 48; n= 269, 237</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="269"/>
                    <count group_id="O2" value="237"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="1.099"/>
                    <measurement group_id="O2" value="-0.01" spread="1.028"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose; Week 52; n= 258, 221</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="258"/>
                    <count group_id="O2" value="221"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="1.142"/>
                    <measurement group_id="O2" value="-0.01" spread="1.443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="2.692"/>
                    <measurement group_id="O2" value="-0.96" spread="2.751"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride; Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="2.752"/>
                    <measurement group_id="O2" value="-1.00" spread="2.833"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="2.709"/>
                    <measurement group_id="O2" value="-0.78" spread="2.773"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="2.887"/>
                    <measurement group_id="O2" value="-0.67" spread="2.818"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="2.569"/>
                    <measurement group_id="O2" value="-0.51" spread="2.880"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="2.663"/>
                    <measurement group_id="O2" value="-0.81" spread="2.441"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="3.111"/>
                    <measurement group_id="O2" value="-0.38" spread="2.739"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="2.754"/>
                    <measurement group_id="O2" value="-0.22" spread="2.650"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Week 8; n= 301, 297</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="297"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="2.695"/>
                    <measurement group_id="O2" value="-0.09" spread="2.564"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="2.978"/>
                    <measurement group_id="O2" value="0.04" spread="2.638"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="2.818"/>
                    <measurement group_id="O2" value="-0.08" spread="2.777"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="2.620"/>
                    <measurement group_id="O2" value="-0.12" spread="2.861"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="2.672"/>
                    <measurement group_id="O2" value="0.28" spread="2.867"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="2.736"/>
                    <measurement group_id="O2" value="0.12" spread="2.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.373"/>
                    <measurement group_id="O2" value="-0.02" spread="0.432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Week 8; n= 301, 297</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="297"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="0.350"/>
                    <measurement group_id="O2" value="0.00" spread="0.428"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.375"/>
                    <measurement group_id="O2" value="0.03" spread="0.443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.401"/>
                    <measurement group_id="O2" value="0.03" spread="0.433"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.363"/>
                    <measurement group_id="O2" value="-0.03" spread="0.417"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.369"/>
                    <measurement group_id="O2" value="0.05" spread="0.423"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.412"/>
                    <measurement group_id="O2" value="0.04" spread="0.416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.188"/>
                    <measurement group_id="O2" value="0.01" spread="0.206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.182"/>
                    <measurement group_id="O2" value="0.03" spread="0.187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.180"/>
                    <measurement group_id="O2" value="0.03" spread="0.193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.174"/>
                    <measurement group_id="O2" value="0.03" spread="0.200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="0.196"/>
                    <measurement group_id="O2" value="0.01" spread="0.217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.193"/>
                    <measurement group_id="O2" value="0.03" spread="0.209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.203"/>
                    <measurement group_id="O2" value="0.01" spread="0.197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.20" spread="2.393"/>
                    <measurement group_id="O2" value="-0.80" spread="2.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="2.420"/>
                    <measurement group_id="O2" value="-0.87" spread="2.569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="2.364"/>
                    <measurement group_id="O2" value="-0.58" spread="2.449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="2.472"/>
                    <measurement group_id="O2" value="-0.53" spread="2.446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="2.375"/>
                    <measurement group_id="O2" value="-0.51" spread="2.410"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="2.277"/>
                    <measurement group_id="O2" value="-0.62" spread="2.505"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="2.886"/>
                    <measurement group_id="O2" value="-0.37" spread="2.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="1.658"/>
                    <measurement group_id="O2" value="0.18" spread="1.253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="1.214"/>
                    <measurement group_id="O2" value="0.23" spread="1.205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="1.269"/>
                    <measurement group_id="O2" value="0.29" spread="1.344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="1.236"/>
                    <measurement group_id="O2" value="0.17" spread="1.308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="1.165"/>
                    <measurement group_id="O2" value="0.20" spread="1.284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="1.260"/>
                    <measurement group_id="O2" value="0.18" spread="1.241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" spread="1.482"/>
                    <measurement group_id="O2" value="0.32" spread="1.311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Week 4; n= 4, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.88" spread="1.081"/>
                    <measurement group_id="O2" value="1.22" spread="1.963"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Week 8; n= 7, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.37" spread="1.158"/>
                    <measurement group_id="O2" value="1.04" spread="1.577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Week 16; n= 270, 261</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="270"/>
                    <count group_id="O2" value="261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.878"/>
                    <measurement group_id="O2" value="0.31" spread="0.872"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Week 24; n= 280, 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.23" spread="0.760"/>
                    <measurement group_id="O2" value="0.29" spread="0.934"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Week 36; n= 283, 272</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.789"/>
                    <measurement group_id="O2" value="0.28" spread="0.901"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Week 48; n= 276, 272</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.808"/>
                    <measurement group_id="O2" value="0.38" spread="0.946"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Week 52; n= 7, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="0.593"/>
                    <measurement group_id="O2" value="-0.18" spread="0.850"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol; Week 4; n= 4, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.197"/>
                    <measurement group_id="O2" value="0.10" spread="0.191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol; Week 8; n= 7,10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.262"/>
                    <measurement group_id="O2" value="0.08" spread="0.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol; Week 16; n= 270, 261</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="270"/>
                    <count group_id="O2" value="261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.300"/>
                    <measurement group_id="O2" value="-0.00" spread="0.341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol; Week 24; n= 280, 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.319"/>
                    <measurement group_id="O2" value="0.00" spread="0.339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol; Week 36; n= 283, 272</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.319"/>
                    <measurement group_id="O2" value="0.00" spread="0.340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol; Week 48; n= 276, 272</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.298"/>
                    <measurement group_id="O2" value="0.03" spread="0.353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HDL cholesterol; Week 52; n= 7,6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.327"/>
                    <measurement group_id="O2" value="0.13" spread="0.327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol; Week 4; n= 4, 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="1.157"/>
                    <measurement group_id="O2" value="-0.17" spread="0.398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol; Week 8; n= 7, 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.09" spread="0.911"/>
                    <measurement group_id="O2" value="0.50" spread="0.720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol; Week 16; n= 259, 246</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="259"/>
                    <count group_id="O2" value="246"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.674"/>
                    <measurement group_id="O2" value="0.06" spread="0.644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol; Week 24; n= 272, 261</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="272"/>
                    <count group_id="O2" value="261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.601"/>
                    <measurement group_id="O2" value="0.05" spread="0.652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol; Week 36; n= 274, 261</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="274"/>
                    <count group_id="O2" value="261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.11" spread="0.606"/>
                    <measurement group_id="O2" value="0.05" spread="0.659"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol; Week 48; n= 269, 264</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="269"/>
                    <count group_id="O2" value="264"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.633"/>
                    <measurement group_id="O2" value="0.11" spread="0.682"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol; Week 52; n= 7, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.511"/>
                    <measurement group_id="O2" value="-0.25" spread="0.857"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides; Week 4; n= 4, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.89" spread="0.852"/>
                    <measurement group_id="O2" value="4.23" spread="5.773"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides; Week 8; n= 7, 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.57" spread="1.153"/>
                    <measurement group_id="O2" value="1.95" spread="5.131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides; Week 16; n= 270, 261</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="270"/>
                    <count group_id="O2" value="261"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="1.131"/>
                    <measurement group_id="O2" value="0.63" spread="1.289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides; Week 24; n= 280, 271</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="280"/>
                    <count group_id="O2" value="271"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.32" spread="0.997"/>
                    <measurement group_id="O2" value="0.67" spread="1.826"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides; Week 36; n= 283, 272</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.31" spread="1.289"/>
                    <measurement group_id="O2" value="0.61" spread="1.497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides; Week 48; n= 276, 272</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="272"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="1.120"/>
                    <measurement group_id="O2" value="0.57" spread="1.488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides; Week 52; n= 7, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.769"/>
                    <measurement group_id="O2" value="-0.15" spread="0.259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, ALT, AST and creatine kinase. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, ALT, AST and creatine kinase. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>International unit per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALP; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.24" spread="21.900"/>
                    <measurement group_id="O2" value="-14.94" spread="22.979"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.73" spread="26.135"/>
                    <measurement group_id="O2" value="-13.46" spread="29.998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.87" spread="31.452"/>
                    <measurement group_id="O2" value="-11.38" spread="26.190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.19" spread="27.800"/>
                    <measurement group_id="O2" value="-6.06" spread="50.943"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.53" spread="28.875"/>
                    <measurement group_id="O2" value="-7.85" spread="30.394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.10" spread="28.935"/>
                    <measurement group_id="O2" value="-6.87" spread="32.071"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.81" spread="29.317"/>
                    <measurement group_id="O2" value="-7.23" spread="31.046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.50" spread="17.285"/>
                    <measurement group_id="O2" value="-10.25" spread="17.639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.49" spread="19.222"/>
                    <measurement group_id="O2" value="-9.04" spread="25.556"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.32" spread="18.502"/>
                    <measurement group_id="O2" value="-8.59" spread="24.507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.87" spread="20.108"/>
                    <measurement group_id="O2" value="-9.20" spread="33.054"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.31" spread="25.356"/>
                    <measurement group_id="O2" value="-11.16" spread="22.196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="39.985"/>
                    <measurement group_id="O2" value="-6.47" spread="51.492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.04" spread="23.232"/>
                    <measurement group_id="O2" value="-10.63" spread="25.508"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.56" spread="17.463"/>
                    <measurement group_id="O2" value="-7.68" spread="13.654"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Week 8; n= 301, 297</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="297"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.89" spread="17.934"/>
                    <measurement group_id="O2" value="-6.64" spread="21.295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.70" spread="17.445"/>
                    <measurement group_id="O2" value="-6.49" spread="18.143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.83" spread="17.713"/>
                    <measurement group_id="O2" value="-6.45" spread="28.933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.76" spread="22.437"/>
                    <measurement group_id="O2" value="-8.36" spread="21.550"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.03" spread="28.194"/>
                    <measurement group_id="O2" value="-6.43" spread="27.155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.51" spread="22.645"/>
                    <measurement group_id="O2" value="-7.55" spread="28.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.85" spread="215.820"/>
                    <measurement group_id="O2" value="-15.59" spread="106.738"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.61" spread="312.940"/>
                    <measurement group_id="O2" value="-10.42" spread="128.109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.75" spread="180.905"/>
                    <measurement group_id="O2" value="11.62" spread="203.660"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.71" spread="312.173"/>
                    <measurement group_id="O2" value="-0.28" spread="186.927"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.34" spread="892.830"/>
                    <measurement group_id="O2" value="-5.08" spread="135.191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.50" spread="451.135"/>
                    <measurement group_id="O2" value="16.52" spread="295.891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.24" spread="228.026"/>
                    <measurement group_id="O2" value="54.97" spread="628.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Albumin Values</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameter including albumin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Albumin Values</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameter including albumin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Gram per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.39" spread="2.554"/>
                    <measurement group_id="O2" value="-0.51" spread="2.670"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="2.792"/>
                    <measurement group_id="O2" value="-0.67" spread="2.828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="3.148"/>
                    <measurement group_id="O2" value="-0.28" spread="3.062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="3.326"/>
                    <measurement group_id="O2" value="-0.06" spread="3.207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="3.479"/>
                    <measurement group_id="O2" value="-0.11" spread="3.091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.71" spread="3.250"/>
                    <measurement group_id="O2" value="0.11" spread="2.912"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" spread="3.605"/>
                    <measurement group_id="O2" value="-0.15" spread="3.142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Creatinine and Bilirubin Values</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine and bilirubin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Creatinine and Bilirubin Values</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine and bilirubin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Micromoles per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Creatinine; Week 4; n= 306, 302</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="302"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.68" spread="9.308"/>
                    <measurement group_id="O2" value="4.69" spread="8.575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Week 8; n= 301, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.81" spread="8.414"/>
                    <measurement group_id="O2" value="5.57" spread="9.214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.46" spread="9.065"/>
                    <measurement group_id="O2" value="5.19" spread="9.648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Week 24; n= 295, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.96" spread="10.248"/>
                    <measurement group_id="O2" value="5.75" spread="11.606"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Week 36; n= 289, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.08" spread="9.667"/>
                    <measurement group_id="O2" value="5.98" spread="14.737"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.92" spread="9.412"/>
                    <measurement group_id="O2" value="6.15" spread="13.373"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.22" spread="10.229"/>
                    <measurement group_id="O2" value="6.15" spread="12.268"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Week 4; n= 305, 301</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="301"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.74" spread="4.982"/>
                    <measurement group_id="O2" value="3.39" spread="3.997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Week 8; n= 301, 297</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="301"/>
                    <count group_id="O2" value="297"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="4.344"/>
                    <measurement group_id="O2" value="3.76" spread="5.291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Week 16; n= 294, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="294"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.79" spread="4.547"/>
                    <measurement group_id="O2" value="3.97" spread="4.957"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Week 24; n= 295, 285</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="285"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.28" spread="4.692"/>
                    <measurement group_id="O2" value="4.15" spread="5.422"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Week 36; n= 289, 275</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.26" spread="4.925"/>
                    <measurement group_id="O2" value="4.43" spread="5.447"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Week 48; n= 278, 246</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="246"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.19" spread="4.288"/>
                    <measurement group_id="O2" value="4.82" spread="5.552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Week 52; n= 276, 238</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="276"/>
                    <count group_id="O2" value="238"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.54" spread="5.231"/>
                    <measurement group_id="O2" value="4.26" spread="4.644"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Lipase Values</title>
        <description>Blood samples were collected from participants to evaluate clinical chemistry parameter including lipase. Change from Baseline in lipase at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Lipase Values</title>
          <description>Blood samples were collected from participants to evaluate clinical chemistry parameter including lipase. Change from Baseline in lipase at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Unit per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4; n= 303, 301</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="303"/>
                    <count group_id="O2" value="301"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.17" spread="11.082"/>
                    <measurement group_id="O2" value="1.52" spread="15.067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8; n= 299, 298</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="299"/>
                    <count group_id="O2" value="298"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="13.422"/>
                    <measurement group_id="O2" value="0.58" spread="10.558"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16; n= 292, 293</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="292"/>
                    <count group_id="O2" value="293"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" spread="17.174"/>
                    <measurement group_id="O2" value="0.94" spread="11.197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; n= 295, 284</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="295"/>
                    <count group_id="O2" value="284"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.19" spread="15.984"/>
                    <measurement group_id="O2" value="1.14" spread="13.770"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36; n= 287, 275</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="15.089"/>
                    <measurement group_id="O2" value="0.11" spread="11.570"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n= 278, 247</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="278"/>
                    <count group_id="O2" value="247"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" spread="14.673"/>
                    <measurement group_id="O2" value="1.68" spread="12.783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52; n= 275, 237</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="275"/>
                    <count group_id="O2" value="237"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.18" spread="22.215"/>
                    <measurement group_id="O2" value="1.59" spread="11.117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Chemistry Toxicities -Randomized Phase</title>
        <description>Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Chemistry Toxicities -Randomized Phase</title>
          <description>Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV, received DTG and were included in DTG group for Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serum glucose; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum glucose; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum glucose; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum glucose; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol calculation; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol calculation; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol calculation; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol calculation; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol direct; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol direct; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol direct; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol direct; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Triglycerides; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Triglycerides; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Triglycerides; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Triglycerides; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Chemistry Toxicities-Continuation Phase</title>
        <description>Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.</description>
        <time_frame>Up to Week 295</time_frame>
        <population>Safety Continuation Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG in Continuation Phase</title>
            <description>Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Chemistry Toxicities-Continuation Phase</title>
          <description>Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.</description>
          <population>Safety Continuation Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serum glucose; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum glucose; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum glucose; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum glucose; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine kinase; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol calculation; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol calculation; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol calculation; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol calculation; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol direct; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol direct; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol direct; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LDL cholesterol direct; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cholesterol; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Triglycerides; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Triglycerides; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Triglycerides; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum Triglycerides; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>10^9 cells/liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophil; Week 4; n= 289, 291</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.029"/>
                    <measurement group_id="O2" value="0.00" spread="0.016"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophil; Week 8; n= 296, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.017"/>
                    <measurement group_id="O2" value="0.00" spread="0.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophil; Week 16; n= 286, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.017"/>
                    <measurement group_id="O2" value="0.00" spread="0.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophil; Week 24; n= 290, 281</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.017"/>
                    <measurement group_id="O2" value="0.00" spread="0.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophil; Week 36; n= 283, 275</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.021"/>
                    <measurement group_id="O2" value="0.00" spread="0.018"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophil; Week 48; n= 266, 242</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="266"/>
                    <count group_id="O2" value="242"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.021"/>
                    <measurement group_id="O2" value="0.01" spread="0.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophil; Week 52; n= 265, 229</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.018"/>
                    <measurement group_id="O2" value="0.01" spread="0.022"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophil; Week 4; n= 290, 291</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.182"/>
                    <measurement group_id="O2" value="0.02" spread="0.287"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophil; Week 8; n= 296, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03" spread="0.281"/>
                    <measurement group_id="O2" value="0.01" spread="0.175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophil; Week 16; n= 286, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.240"/>
                    <measurement group_id="O2" value="0.01" spread="0.201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophil; Week 24; n= 290, 281</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.188"/>
                    <measurement group_id="O2" value="0.01" spread="0.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophil; Week 36; n= 283, 275</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.214"/>
                    <measurement group_id="O2" value="0.02" spread="0.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophil; Week 48; n= 266, 242</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="266"/>
                    <count group_id="O2" value="242"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.04" spread="0.267"/>
                    <measurement group_id="O2" value="0.01" spread="0.210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophil; Week 52; n= 265, 229</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.188"/>
                    <measurement group_id="O2" value="0.01" spread="0.217"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte; Week 4; n= 289, 291</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.519"/>
                    <measurement group_id="O2" value="0.10" spread="0.549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte; Week 8; n= 296, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.592"/>
                    <measurement group_id="O2" value="0.29" spread="0.651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte; Week 16; n= 286, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="0.611"/>
                    <measurement group_id="O2" value="0.29" spread="0.668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte; Week 24; n= 290, 281</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="0.589"/>
                    <measurement group_id="O2" value="0.34" spread="0.625"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte; Week 36; n= 283, 275</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.595"/>
                    <measurement group_id="O2" value="0.35" spread="0.646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte; Week 48; n= 266, 242</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="266"/>
                    <count group_id="O2" value="242"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.648"/>
                    <measurement group_id="O2" value="0.37" spread="0.697"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte; Week 52; n= 265, 229</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.716"/>
                    <measurement group_id="O2" value="0.39" spread="0.720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte; Week 4; n= 289, 291</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.201"/>
                    <measurement group_id="O2" value="0.00" spread="0.167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte; Week 8; n= 296, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.159"/>
                    <measurement group_id="O2" value="0.02" spread="0.174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte; Week 16; n= 286, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.00" spread="0.140"/>
                    <measurement group_id="O2" value="0.01" spread="0.154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte; Week 24; n= 290, 281</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.139"/>
                    <measurement group_id="O2" value="0.01" spread="0.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte; Week 36; n= 283, 275</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.151"/>
                    <measurement group_id="O2" value="0.02" spread="0.175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte; Week 48; n= 266, 242</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="266"/>
                    <count group_id="O2" value="242"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.157"/>
                    <measurement group_id="O2" value="0.03" spread="0.190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocyte; Week 52; n= 265, 229</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.173"/>
                    <measurement group_id="O2" value="0.02" spread="0.205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil; Week 4; n= 289, 291</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="291"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="1.914"/>
                    <measurement group_id="O2" value="0.23" spread="1.407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil; Week 8; n= 296, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="1.491"/>
                    <measurement group_id="O2" value="0.23" spread="1.678"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil; Week 16; n= 286, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.31" spread="1.462"/>
                    <measurement group_id="O2" value="0.29" spread="1.481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil; Week 24; n= 290, 281</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="281"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.42" spread="1.694"/>
                    <measurement group_id="O2" value="0.34" spread="1.315"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil; Week 36; n= 283, 275</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="1.605"/>
                    <measurement group_id="O2" value="0.37" spread="1.661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil; Week 48; n= 266, 242</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="266"/>
                    <count group_id="O2" value="242"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="1.491"/>
                    <measurement group_id="O2" value="0.50" spread="1.449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophil; Week 52; n= 265, 229</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="229"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="1.691"/>
                    <measurement group_id="O2" value="0.44" spread="1.604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet; Week 4; n= 291, 293</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                    <count group_id="O2" value="293"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.81" spread="63.368"/>
                    <measurement group_id="O2" value="23.64" spread="53.514"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet; Week 8; n= 293, 293</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="293"/>
                    <count group_id="O2" value="293"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.95" spread="62.969"/>
                    <measurement group_id="O2" value="26.17" spread="58.634"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet; Week 16; n= 287, 286</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="287"/>
                    <count group_id="O2" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.77" spread="66.974"/>
                    <measurement group_id="O2" value="28.03" spread="61.780"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet; Week 24; n= 290, 282</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="282"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.79" spread="63.702"/>
                    <measurement group_id="O2" value="27.32" spread="65.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet; Week 36; n= 283, 274</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="283"/>
                    <count group_id="O2" value="274"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.02" spread="69.570"/>
                    <measurement group_id="O2" value="21.41" spread="64.787"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet; Week 48; n= 265, 246</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="265"/>
                    <count group_id="O2" value="246"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.72" spread="66.983"/>
                    <measurement group_id="O2" value="30.20" spread="63.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet; Week 52; n= 267, 232</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="267"/>
                    <count group_id="O2" value="232"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.98" spread="66.402"/>
                    <measurement group_id="O2" value="32.60" spread="71.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocyte; Week 4; n= 289, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" spread="2.105"/>
                    <measurement group_id="O2" value="0.37" spread="1.607"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocyte; Week 8; n= 296, 292</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="292"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="1.676"/>
                    <measurement group_id="O2" value="0.54" spread="1.879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocyte; Week 16; n= 290, 288</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="288"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="1.622"/>
                    <measurement group_id="O2" value="0.60" spread="1.746"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocyte; Week 24; n= 291, 284</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                    <count group_id="O2" value="284"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" spread="1.826"/>
                    <measurement group_id="O2" value="0.70" spread="1.545"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocyte; Week 36; n= 285, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="285"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91" spread="1.777"/>
                    <measurement group_id="O2" value="0.76" spread="1.913"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocyte; Week 48; n= 267, 245</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="267"/>
                    <count group_id="O2" value="245"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91" spread="1.777"/>
                    <measurement group_id="O2" value="0.90" spread="1.718"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocyte; Week 52; 268, 231</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="231"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" spread="1.908"/>
                    <measurement group_id="O2" value="0.86" spread="1.819"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hematocrit Values</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameter including hematocrit. Change from Baseline in hematocrit values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematocrit Values</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameter including hematocrit. Change from Baseline in hematocrit values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Proportion of red blood cells in blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4; n= 296, 296</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.00" spread="0.032"/>
                    <measurement group_id="O2" value="-0.01" spread="0.029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8; n= 297, 294</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.039"/>
                    <measurement group_id="O2" value="-0.01" spread="0.037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16; n= 290, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.044"/>
                    <measurement group_id="O2" value="-0.01" spread="0.042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; n= 291, 285</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                    <count group_id="O2" value="285"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.037"/>
                    <measurement group_id="O2" value="-0.00" spread="0.039"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36; n= 286, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.038"/>
                    <measurement group_id="O2" value="-0.00" spread="0.039"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n= 268, 248</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="248"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.038"/>
                    <measurement group_id="O2" value="-0.00" spread="0.041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52; n= 269, 233</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="269"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.040"/>
                    <measurement group_id="O2" value="-0.00" spread="0.041"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hemoglobin Values</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameter including hemoglobin. Change from Baseline in hemoglobin values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin Values</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameter including hemoglobin. Change from Baseline in hemoglobin values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Gram per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4; n= 296, 296</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="9.858"/>
                    <measurement group_id="O2" value="-4.23" spread="8.994"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8; n= 297, 294</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="11.725"/>
                    <measurement group_id="O2" value="-4.41" spread="11.340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16; n= 290, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.39" spread="12.905"/>
                    <measurement group_id="O2" value="-2.10" spread="12.904"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; n= 291, 285</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                    <count group_id="O2" value="285"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.05" spread="10.881"/>
                    <measurement group_id="O2" value="-0.46" spread="12.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36; n= 286, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.18" spread="11.968"/>
                    <measurement group_id="O2" value="0.34" spread="12.628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n= 268, 248</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="248"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.05" spread="12.138"/>
                    <measurement group_id="O2" value="0.90" spread="13.486"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52; n= 269, 233</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="269"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.68" spread="12.457"/>
                    <measurement group_id="O2" value="1.07" spread="13.361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Mean Corpuscular Volume (MCV)</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameter including MCV. Change from Baseline in MCV values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Mean Corpuscular Volume (MCV)</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameter including MCV. Change from Baseline in MCV values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>Femtoliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4; n= 296, 296</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="3.820"/>
                    <measurement group_id="O2" value="0.46" spread="3.799"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8; n= 297, 294</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.72" spread="7.659"/>
                    <measurement group_id="O2" value="1.78" spread="7.266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16; n= 290, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.91" spread="13.827"/>
                    <measurement group_id="O2" value="3.83" spread="13.600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; n= 291, 285</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                    <count group_id="O2" value="285"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.86" spread="15.279"/>
                    <measurement group_id="O2" value="4.39" spread="15.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36; n= 286, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.33" spread="15.450"/>
                    <measurement group_id="O2" value="4.62" spread="15.413"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n= 268, 248</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="248"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.14" spread="15.637"/>
                    <measurement group_id="O2" value="4.79" spread="15.463"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52; n= 269, 233</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="269"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.36" spread="15.496"/>
                    <measurement group_id="O2" value="4.72" spread="15.697"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Erythrocyte Values</title>
        <description>Blood samples were collected from participants to evaluate clinical hematology parameter including erythrocyte. Change from Baseline in erythrocyte values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and up to Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Erythrocyte Values</title>
          <description>Blood samples were collected from participants to evaluate clinical hematology parameter including erythrocyte. Change from Baseline in erythrocyte values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).</population>
          <units>10^12 cells/liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4; n= 296, 296</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="296"/>
                    <count group_id="O2" value="296"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.385"/>
                    <measurement group_id="O2" value="-0.16" spread="0.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8; n= 297, 294</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="297"/>
                    <count group_id="O2" value="294"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.07" spread="0.558"/>
                    <measurement group_id="O2" value="-0.23" spread="0.529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16; n= 290, 289</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="290"/>
                    <count group_id="O2" value="289"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.808"/>
                    <measurement group_id="O2" value="-0.21" spread="0.754"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; n= 291, 285</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="291"/>
                    <count group_id="O2" value="285"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.08" spread="0.768"/>
                    <measurement group_id="O2" value="-0.20" spread="0.747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36; n= 286, 276</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                    <count group_id="O2" value="276"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.792"/>
                    <measurement group_id="O2" value="-0.18" spread="0.749"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n= 268, 248</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="268"/>
                    <count group_id="O2" value="248"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.798"/>
                    <measurement group_id="O2" value="-0.18" spread="0.750"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52; n= 269, 233</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="269"/>
                    <count group_id="O2" value="233"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="0.788"/>
                    <measurement group_id="O2" value="-0.17" spread="0.761"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hematology Toxicities -Randomized Phase</title>
        <description>Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hematology Toxicities -Randomized Phase</title>
          <description>Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hematology Toxicities-Continuation Phase</title>
        <description>Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.</description>
        <time_frame>Up to Week 295</time_frame>
        <population>Safety-Continuation Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG in Continuation Phase</title>
            <description>Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hematology Toxicities-Continuation Phase</title>
          <description>Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.</description>
          <population>Safety-Continuation Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets; Grade 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase</title>
        <description>Number of participants who discontinued study treatment due to AEs or SAEs were summarized.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase</title>
          <description>Number of participants who discontinued study treatment due to AEs or SAEs were summarized.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Discontinued Treatment Due to AEs-Continuation Phase</title>
        <description>Number of participants who discontinued study treatment due to AEs were summarized.</description>
        <time_frame>Up to Week 295</time_frame>
        <population>Safety-Continuation Population</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG in Continuation Phase</title>
            <description>Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Treatment Due to AEs-Continuation Phase</title>
          <description>Number of participants who discontinued study treatment due to AEs were summarized.</description>
          <population>Safety-Continuation Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48</title>
        <description>Blood samples were collected from participants in fasting state to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Analysis was performed using multiple imputation with missing at random assumption. Only participants available at the time of evaluation were analyzed.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 24 and Week 48</time_frame>
        <population>Safety Population. Only those participants with data available at specified time points were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48</title>
          <description>Blood samples were collected from participants in fasting state to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Analysis was performed using multiple imputation with missing at random assumption. Only participants available at the time of evaluation were analyzed.</description>
          <population>Safety Population. Only those participants with data available at specified time points were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
          <units>Millimoles per liter</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="303"/>
                <count group_id="O2" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.121" spread="0.0356"/>
                    <measurement group_id="O2" value="0.050" spread="0.0378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.012" spread="0.0387"/>
                    <measurement group_id="O2" value="0.135" spread="0.0416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0010</p_value>
            <method>Multiple imputation</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.171</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.272</ci_lower_limit>
            <ci_upper_limit>-0.069</ci_upper_limit>
            <estimate_desc>Mean difference at Week 24 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0100</p_value>
            <method>'Multiple imputation</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.147</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.259</ci_lower_limit>
            <ci_upper_limit>-0.035</ci_upper_limit>
            <estimate_desc>Mean difference at Week 48 was calculated using multiple imputation using missing at random, adjusting for Baseline LDL cholesterol, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio</title>
        <description>Blood samples were collected from participants in fasting state to evaluate total cholesterol/HDL cholesterol ratio. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only participants available at the time of evaluation were analyzed. Analysis was performed using multiple imputation with missing at random assumption.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 24 and Week 48</time_frame>
        <population>Safety Population. Only those participants with data available at specified time point were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio</title>
          <description>Blood samples were collected from participants in fasting state to evaluate total cholesterol/HDL cholesterol ratio. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only participants available at the time of evaluation were analyzed. Analysis was performed using multiple imputation with missing at random assumption.</description>
          <population>Safety Population. Only those participants with data available at specified time point were analyzed. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
          <units>Ratio</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="306"/>
                <count group_id="O2" value="295"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.237" spread="0.0662"/>
                    <measurement group_id="O2" value="0.305" spread="0.0683"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.084" spread="0.0693"/>
                    <measurement group_id="O2" value="0.275" spread="0.0729"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Multiple imputation</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.542</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.729</ci_lower_limit>
            <ci_upper_limit>-0.356</ci_upper_limit>
            <estimate_desc>Estimates at Week 24 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0004</p_value>
            <method>Multiple imputation</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>-0.358</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.555</ci_lower_limit>
            <ci_upper_limit>-0.161</ci_upper_limit>
            <estimate_desc>Estimates at Week 48 are calculated using multiple imputation using missing at random, adjusting for Baseline total cholesterol/HDL ratio, Baseline plasma HIV-1 RNA, Baseline number of Fully Active NRTIs in the background regimen and Age.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol</title>
        <description>Blood samples were collected from participants in fasting state at indicated time-points to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in fasting LDL cholesterol was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol</title>
          <description>Blood samples were collected from participants in fasting state at indicated time-points to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in fasting LDL cholesterol was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea</title>
        <description>Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in drug-related diarrhea was summarized. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.</description>
        <time_frame>Week 24 and Week 48</time_frame>
        <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea</title>
          <description>Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in drug-related diarrhea was summarized. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.</description>
          <population>Safety Population. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="314"/>
                <count group_id="O2" value="310"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score</title>
        <description>The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The scale ranges from 1= no discomfort to 7= very severe discomfort for each symptom cluster. Higher scores show greater severity of symptoms. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using Last Observation Carried Forward (LOCF) dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48</time_frame>
        <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).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score</title>
          <description>The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The scale ranges from 1= no discomfort to 7= very severe discomfort for each symptom cluster. Higher scores show greater severity of symptoms. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using Last Observation Carried Forward (LOCF) dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
          <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).</population>
          <units>Scores on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diarrhea Syndrome Score; Week 4; n= 303, 305</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="303"/>
                    <count group_id="O2" value="305"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.33" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea Syndrome Score; Week 24; n= 305, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.33" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea Syndrome Score; Week 48; n= 305, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.33" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indigestion Syndrome Score; Week 4; n=305, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.25" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indigestion Syndrome Score; Week 24; n= 306, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.25" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-0.25" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indigestion Syndrome Score; Week 48; n= 306, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.50" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-0.25" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation Score; Week 4; n= 305, 305</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="305"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation Score; Week 24; n= 306, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation Score; Week 48; n= 306, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain Score; Week 4; n= 305, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.33" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain Score; Week 24; n= 306, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.33" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="-0.33" upper_limit="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain Score; Week 48; n= 306, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.67" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflux Score; Week 4; n= 305, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflux Score; Week 24; n= 306, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reflux Score; Week 48; n= 306, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="0.00" upper_limit="0.00"/>
                    <measurement group_id="O2" value="0.00" lower_limit="0.00" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score</title>
        <description>The HIVTSQ is a self-reported scales that measure overall satisfaction with treatment. The score ranges from 0-10. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48</time_frame>
        <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).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score</title>
          <description>The HIVTSQ is a self-reported scales that measure overall satisfaction with treatment. The score ranges from 0-10. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
          <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).</population>
          <units>Scores on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4; n= 304, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="304"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="0.0" upper_limit="11.5"/>
                    <measurement group_id="O2" value="2.0" lower_limit="0.0" upper_limit="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; n= 305, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="0.0" upper_limit="13.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="0.0" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; n= 305, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="305"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="0.0" upper_limit="14.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="0.0" upper_limit="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8)</title>
        <description>Treatment compliance was evaluated through MMAS-8. It is an eight-item self-reported measure of medication-taking behavior. The score ranges from 0-8 where scores of 8 indicate high or near perfect adherence, and scores of less than 6 indicate poor or inadequate adherence on the MMAS-8 scale. Number of participants showing low, medium and high adherence to treatment are presented. Low adherence is a score 0-5.75, medium adherence is a score of 6-7.75 and high adherence is a score of 8. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
        <time_frame>Baseline (Day 1, Pre-dose), Week 4, Week 24 and Week 48</time_frame>
        <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).</population>
        <group_list>
          <group group_id="O1">
            <title>Participants Receiving DTG-Randomized Phase</title>
            <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
          </group>
          <group group_id="O2">
            <title>Participants Receiving LPV/RTV-Randomized Phase</title>
            <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8)</title>
          <description>Treatment compliance was evaluated through MMAS-8. It is an eight-item self-reported measure of medication-taking behavior. The score ranges from 0-8 where scores of 8 indicate high or near perfect adherence, and scores of less than 6 indicate poor or inadequate adherence on the MMAS-8 scale. Number of participants showing low, medium and high adherence to treatment are presented. Low adherence is a score 0-5.75, medium adherence is a score of 6-7.75 and high adherence is a score of 8. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.</description>
          <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).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="312"/>
                <count group_id="O2" value="312"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (Day 1, Pre-dose); low; n= 309, 312</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Day 1, Pre-dose); medium; n= 309, 312</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (Day 1, Pre-dose); high; n= 309, 312</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="312"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4; low; n= 306, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4; medium; n= 306, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4; high n= 306, 306</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="306"/>
                    <count group_id="O2" value="306"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208"/>
                    <measurement group_id="O2" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; low; n= 307, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="307"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; medium; n= 307, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="307"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24; high; n= 307,307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="307"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="199"/>
                    <measurement group_id="O2" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; low; n= 307, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="307"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; medium; n= 307, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="307"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48; high; n= 307, 307</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="307"/>
                    <count group_id="O2" value="307"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205"/>
                    <measurement group_id="O2" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 52 for Randomized Phase; up to Week 295 for Continuation Phase and up to Week 348 for Randomized Phase+Continuation Phase.</time_frame>
      <desc>All-cause mortality, SAEs and non-SAEs were reported for the Safety Population for the Randomized Phase and Randomized + Continuation Phase. Two participants who were randomized to receive LPV/RTV received DTG and were included in DTG group for Safety Population. Safety-Continuation Population was used for the Continuation Phase.</desc>
      <group_list>
        <group group_id="E1">
          <title>Participants Receiving DTG-Randomized Phase</title>
          <description>Participants received 1 tablet of 50 milligrams (mg) of DTG once daily along with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) via oral route for 52 weeks during Randomized Phase.</description>
        </group>
        <group group_id="E2">
          <title>Participants Receiving LPV/RTV-Randomized Phase</title>
          <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase.</description>
        </group>
        <group group_id="E3">
          <title>Participants Receiving DTG-Continuation Phase</title>
          <description>Participants received DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
        </group>
        <group group_id="E4">
          <title>DTG in Randomized Phase Followed by Continuation Phase</title>
          <description>Participants received 1 tablet of 50 mg of DTG once daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants who completed 52 weeks of treatment, continued to receive DTG in the Continuation Phase until it was either locally approved or commercial supplies were available.</description>
        </group>
        <group group_id="E5">
          <title>LPV/RTV-Randomized Phase Followed by DTG in Continuation Phase</title>
          <description>Participants received 4 tablets containing 200/50 mg of LPV/RTV once daily or 2 tablets containing 200/50 mg of LPV/RTV twice daily along with 2 NRTIs via oral route for 52 weeks during Randomized Phase. Participants switched to DTG by Week 52 continued to receive DTG in Continuation Phase until it was either locally approved and commercial supplies were available.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="310"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="274"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="314"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="314"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="310"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="274"/>
                <counts group_id="E4" subjects_affected="47" subjects_at_risk="314"/>
                <counts group_id="E5" subjects_affected="20" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Gastrointestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Immune reconstitution inflammatory syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="314"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="314"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cerebral toxoplasmosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Bone tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cholecystitis infective</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus chorioretinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Epstein-Barr virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Extrapulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Immune reconstitution inflammatory syndrome associated tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Helicobacter gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Intestinal tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Leptospirosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Meningitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Meningitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Secondary syphilis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Tuberculosis gastrointestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Exposure to toxic agent</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="274"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Burns first degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Benign ovarian tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cerebellopontine angle tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hodgkin's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Ovarian epithelial cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Penile cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="274"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="274"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="155" subjects_at_risk="314"/>
                <counts group_id="E2" subjects_affected="202" subjects_at_risk="310"/>
                <counts group_id="E3" subjects_affected="150" subjects_at_risk="274"/>
                <counts group_id="E4" subjects_affected="218" subjects_at_risk="314"/>
                <counts group_id="E5" subjects_affected="213" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="314"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="314"/>
                <counts group_id="E5" events="14" subjects_affected="13" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="35" subjects_affected="28" subjects_at_risk="314"/>
                <counts group_id="E2" events="134" subjects_affected="105" subjects_at_risk="310"/>
                <counts group_id="E3" events="25" subjects_affected="19" subjects_at_risk="274"/>
                <counts group_id="E4" events="54" subjects_affected="38" subjects_at_risk="314"/>
                <counts group_id="E5" events="134" subjects_affected="105" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="314"/>
                <counts group_id="E2" events="33" subjects_affected="30" subjects_at_risk="310"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="274"/>
                <counts group_id="E4" events="16" subjects_affected="14" subjects_at_risk="314"/>
                <counts group_id="E5" events="33" subjects_affected="30" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="314"/>
                <counts group_id="E2" events="24" subjects_affected="21" subjects_at_risk="310"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="274"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="314"/>
                <counts group_id="E5" events="24" subjects_affected="21" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="314"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="310"/>
                <counts group_id="E3" events="12" subjects_affected="9" subjects_at_risk="274"/>
                <counts group_id="E4" events="22" subjects_affected="19" subjects_at_risk="314"/>
                <counts group_id="E5" events="13" subjects_affected="12" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="314"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="310"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="274"/>
                <counts group_id="E4" events="17" subjects_affected="16" subjects_at_risk="314"/>
                <counts group_id="E5" events="9" subjects_affected="8" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="314"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="314"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="274"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="274"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="314"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="9" subjects_affected="8" subjects_at_risk="314"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="11" subjects_affected="11" subjects_at_risk="314"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="274"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="59" subjects_affected="45" subjects_at_risk="314"/>
                <counts group_id="E2" events="52" subjects_affected="43" subjects_at_risk="310"/>
                <counts group_id="E3" events="122" subjects_affected="65" subjects_at_risk="274"/>
                <counts group_id="E4" events="178" subjects_affected="83" subjects_at_risk="314"/>
                <counts group_id="E5" events="52" subjects_affected="43" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="20" subjects_affected="13" subjects_at_risk="314"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="310"/>
                <counts group_id="E3" events="28" subjects_affected="16" subjects_at_risk="274"/>
                <counts group_id="E4" events="48" subjects_affected="22" subjects_at_risk="314"/>
                <counts group_id="E5" events="17" subjects_affected="14" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="314"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="310"/>
                <counts group_id="E3" events="11" subjects_affected="10" subjects_at_risk="274"/>
                <counts group_id="E4" events="19" subjects_affected="17" subjects_at_risk="314"/>
                <counts group_id="E5" events="13" subjects_affected="12" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="310"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="274"/>
                <counts group_id="E4" events="22" subjects_affected="18" subjects_at_risk="314"/>
                <counts group_id="E5" events="10" subjects_affected="9" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="314"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Syphilis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="310"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="274"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="314"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="314"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="310"/>
                <counts group_id="E3" events="15" subjects_affected="12" subjects_at_risk="274"/>
                <counts group_id="E4" events="25" subjects_affected="18" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="314"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="310"/>
                <counts group_id="E3" events="11" subjects_affected="8" subjects_at_risk="274"/>
                <counts group_id="E4" events="14" subjects_affected="10" subjects_at_risk="314"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="314"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="314"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="274"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="314"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="274"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="314"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="274"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="14" subjects_affected="10" subjects_at_risk="274"/>
                <counts group_id="E4" events="15" subjects_affected="11" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="274"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="13" subjects_affected="10" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="310"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="274"/>
                <counts group_id="E4" events="16" subjects_affected="14" subjects_at_risk="314"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="14" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="314"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="310"/>
                <counts group_id="E3" events="14" subjects_affected="12" subjects_at_risk="274"/>
                <counts group_id="E4" events="25" subjects_affected="20" subjects_at_risk="314"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="20" subjects_affected="19" subjects_at_risk="274"/>
                <counts group_id="E4" events="27" subjects_affected="24" subjects_at_risk="314"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="274"/>
                <counts group_id="E4" events="14" subjects_affected="12" subjects_at_risk="314"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="314"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="9" subjects_affected="8" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="24" subjects_affected="24" subjects_at_risk="314"/>
                <counts group_id="E2" events="17" subjects_affected="16" subjects_at_risk="310"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="274"/>
                <counts group_id="E4" events="39" subjects_affected="37" subjects_at_risk="314"/>
                <counts group_id="E5" events="17" subjects_affected="16" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="314"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="11" subjects_affected="9" subjects_at_risk="314"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="314"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="310"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="274"/>
                <counts group_id="E4" events="15" subjects_affected="14" subjects_at_risk="314"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="314"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="310"/>
                <counts group_id="E3" events="18" subjects_affected="16" subjects_at_risk="274"/>
                <counts group_id="E4" events="34" subjects_affected="27" subjects_at_risk="314"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="314"/>
                <counts group_id="E2" events="13" subjects_affected="10" subjects_at_risk="310"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="274"/>
                <counts group_id="E4" events="19" subjects_affected="17" subjects_at_risk="314"/>
                <counts group_id="E5" events="13" subjects_affected="10" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="314"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="314"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="274"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="310"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="274"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="314"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="314"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" events="14" subjects_affected="10" subjects_at_risk="274"/>
                <counts group_id="E4" events="19" subjects_affected="15" subjects_at_risk="314"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="310"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>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.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>ViiV Healthcare</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02227238
org study id: 200304
secondary id: 2014-001057-17
nct id: NCT02227238
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
For treatment of human immunodeficiency virus type 1(HIV-1), publicly funded programmes tend
      to follow World Health Organization (WHO) guidelines to use a non-nucleoside reverse
      transcriptase inhibitor (NNRTI) combined with two nucleoside reverse transcriptase inhibitors
      (NRTIs) for first-line antiretroviral therapy (ART); however, there is a need for further
      data on the best treatment options for people with HIV-1 who have virological failure with
      this first-line regimen. The number of patients failing on their first-line regimen is
      increasing thereby requiring a switch to second-line treatment to reduce accumulation of
      drug-resistance mutations, disease progression, HIV transmission, and death. WHO guidelines
      recommend second-line antiretroviral therapy for adults consisting of two NRTIs + a
      ritonavir-boosted protease inhibitor (PI); atazanavir (ATV) plus ritonavir (RTV) or lopinavir
      (LPV)/RTV are the preferred boosted PI options. This study is conducted to demonstrate
      non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen
      compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV +
      two NRTIs, in HIV-1 infected patients failing first line therapy. This study comprises of a
      Screening Phase (approximately 28 to 42 days), a Randomized Phase (Day 1 to Week 48 plus a
      4-week treatment extension), and a Continuation Phase. Approximately 612 subjects will be
      randomized 1:1 to receive DTG 50 milligram (mg) once daily or LPV/RTV (800/200 mg once daily
      or 400/100 mg twice daily, in accordance with investigator decision and local label), each
      added to an investigator selected background regimen of two NRTIs at least one of which needs
      to be fully active based on viral resistance testing at Screening. Subjects randomized to the
      LPV/RTV arm will either (i) continue receiving LPV/RTV and complete the study after the
      4-week treatment extension at Week 52, or (ii) switch to the DTG arm prior to study
      completion at Week 52 and continue to have access to DTG in the Continuation Phase. Subjects
      randomized to receive DTG who successfully complete 52 weeks of treatment and subjects
      originally randomized to receive LPV/RTV but switched to DTG prior to Week 52 will continue
      to have access to DTG until it is either locally approved and commercial supplies are
      available to patients or the patient no longer derives clinical benefit, or the patient meets
      a protocol-defined reason for discontinuation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies Per Milliliter (c/mL) at Week 48
time frame: Week 48
description: Percentage of participants with plasma HIV 1 RNA <50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.
measure: Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24
time frame: Week 24
description: Percentage of participants with plasma HIV 1 RNA <50 c/mL at Week 24 using the FDA snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Percentage values are rounded off.
measure: Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Weeks 24 and 48
time frame: Week 24 and Week 48
description: Percentage of participants with plasma HIV 1 RNA <400 c/mL at Week 24 and 48 using the FDA snapshot algorithm were evaluated. Percentage values are rounded off.
measure: Percentage of Participants Without Virologic or Tolerability Failure at Week 24 and Week 48
time frame: Week 24 and Week 48
description: Virologic or tolerability failure was defined as treatment-related discontinuation (meeting confirmed virologic withdrawal criteria, treatment-related adverse event, safety stopping criteria, and lack of efficacy). Percentage of participants without virologic failure by Week 24 and Week 48 have been presented. Participants who did not met the protocol defined confirmed virologic withdrawal criteria and are ongoing in the study, or who had discontinued for non-treatment related reasons were censored.
measure: Time to Viral Suppression at Week 48
time frame: Week 48
description: Viral suppression was defined as HIV-1 RNA <50 c/mL. Time to viral suppression was analyzed and median and interquartile range has been presented.
measure: Change From Baseline in Helper-inducer T-lymphocyte Having Surface Antigen Cluster of Differentiation (CD4+) Cell Count at Weeks 24 and 48
time frame: Baseline (Day 1, Pre-dose), Week 24 and Week 48
description: Blood was collected and CD4+ cell count assessment was carried out at indicated time points to evaluate the immunological activity of DTG compared to LPV/RTV. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value.
measure: Number of Participants With Disease Progression-Randomized + Continuation Phase
time frame: Up to Week 348
description: Disease progression included HIV-associated conditions, acquired immune deficiency syndrome (AIDS) and death. Number of participants with disease progression to Centers for Disease Control and Prevention (CDC) class C or death have been presented.
measure: Number of Participants With Treatment-emergent Genotypic Resistance-Randomized Phase
time frame: Up to Week 52
description: Number of participants, who met confirmed virologic withdrawal (CVW) criteria with paired Baseline and time of CVW resistance data with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Viral Genotypic Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met during Randomized Phase.
measure: Number of Participants With Treatment-emergent Genotypic Resistance-Continuation Phase
time frame: Up to Week 295
description: Number of participants, who met confirmed virologic withdrawal criteria with paired Baseline and time of CVW resistance data, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI), NRTI, Protease inhibitor (PI) were summarized. Analysis was performed on Viral Genotypic Continuation Population which comprised all participants in the ITT-E- Continuation Population with available on-treatment genotypic resistance data in the Continuation Phase.
measure: Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Randomized Phase
time frame: Baseline (Day 1, Pre-dose) and up to Week 52
description: Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG, LPV/RTV was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to >2 from Baseline is presented. Analysis was performed on viral phenotypic Population, which comprised of all participants in the ITT-E Population with available On-treatment phenotypic resistance data at the time confirmed virologic withdrawal criterion is met during Randomized Phase.
measure: Number of Participants With Fold Change in Treatment-emergent Phenotypic Resistance From Baseline-Continuation Phase
time frame: Baseline (Day 1, Pre-dose) and up to Week 295
description: Number of participants with fold change in treatment-emergent phenotypic resistance from Baseline to DTG was counted to assess the development of viral resistance. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Change in grade 0 to >2 from Baseline is presented. Analysis was performed on Viral Phenotypic Continuation Population which comprises all participants in the ITT-E- Continuation Population with available on-treatment phenotypic resistance data in the Continuation Phase.
measure: Number of Participants With Non-serious Adverse Events (AEs) With >=2% Frequency Threshold and Serious Adverse Events (SAEs)-Randomized Phase
time frame: Up to Week 52
description: An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Safety Population was used which comprised of all participants who received at least one dose of study treatment. Adverse events which were not Serious were considered as Non-Serious adverse events.
measure: Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Continuation Phase
time frame: Up to Week 295
description: An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.
measure: Number of Participants With Non-serious AEs With >=2% Frequency Threshold and SAEs-Randomized + Continuation Phase
time frame: Up to Week 348
description: An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, other situations as per medical or scientific judgment and is associated with liver injury or impaired liver function. Adverse events which were not Serious were considered as non-serious AEs.
measure: Change From Baseline in Glucose, Chloride, Carbon-di-oxide (CO2), Potassium, Phosphate, Sodium, Urea, Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol and Triglycerides
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
description: Blood samples were collected from participants to evaluate clinical chemistry parameters including glucose, chloride, carbon-di-oxide (CO2), potassium, phosphate, sodium, urea, cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Lipid parameters were evaluated in fasting condition. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase Values
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
description: Blood samples were collected from participants to evaluate clinical chemistry parameters including ALP, ALT, AST and creatine kinase. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Change From Baseline in Albumin Values
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
description: Blood samples were collected from participants to evaluate clinical chemistry parameter including albumin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Change From Baseline in Creatinine and Bilirubin Values
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
description: Blood samples were collected from participants to evaluate clinical chemistry parameters including creatinine and bilirubin. Change from Baseline in clinical chemistry parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Change From Baseline in Lipase Values
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
description: Blood samples were collected from participants to evaluate clinical chemistry parameter including lipase. Change from Baseline in lipase at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Number of Participants With Clinical Chemistry Toxicities -Randomized Phase
time frame: Up to Week 52
description: Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.
measure: Number of Participants With Clinical Chemistry Toxicities-Continuation Phase
time frame: Up to Week 295
description: Number of participants with clinical chemistry toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Lipids and glucose parameters were summarized on fasting data. Data has been reported for clinical chemistry parameters including serum glucose, ALT, Albumin, ALP, AST, Bilirubin, CO2, Creatine kinase, LDL cholesterol calculation, LDL cholesterol direct, Lipase, Phosphate, Potassium, Sodium, Cholesterol, Creatinine and Serum Triglycerides.
measure: Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
description: Blood samples were collected from participants to evaluate clinical hematology parameters including basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Change from Baseline in clinical hematology parameters at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Change From Baseline in Hematocrit Values
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52
description: Blood samples were collected from participants to evaluate clinical hematology parameter including hematocrit. Change from Baseline in hematocrit values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Change From Baseline in Hemoglobin Values
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and Week 52
description: Blood samples were collected from participants to evaluate clinical hematology parameter including hemoglobin. Change from Baseline in hemoglobin values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Change From Baseline in Mean Corpuscular Volume (MCV)
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and and Week 52
description: Blood samples were collected from participants to evaluate clinical hematology parameter including MCV. Change from Baseline in MCV values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Change From Baseline in Erythrocyte Values
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 8, Week 16, Week 24, Week 36, Week 48 and up to Week 52
description: Blood samples were collected from participants to evaluate clinical hematology parameter including erythrocyte. Change from Baseline in erythrocyte values at Weeks 4, 8, 16, 24, 36, 48, 52 are presented. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value.
measure: Number of Participants With Hematology Toxicities -Randomized Phase
time frame: Up to Week 52
description: Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.
measure: Number of Participants With Hematology Toxicities-Continuation Phase
time frame: Up to Week 295
description: Number of participants with hematology toxicities has been presented. Toxicities were based on the Division of AIDS (DAIDS) grading system. Grade 1=Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for hematology parameters including Hemoglobin, Leukocytes, Neutrophils and Platelets.
measure: Number of Participants Who Discontinued Treatment Due to AEs-Randomized Phase
time frame: Up to Week 52
description: Number of participants who discontinued study treatment due to AEs or SAEs were summarized.
measure: Number of Participants Who Discontinued Treatment Due to AEs-Continuation Phase
time frame: Up to Week 295
description: Number of participants who discontinued study treatment due to AEs were summarized.
measure: Change From Baseline in Fasting LDL Cholesterol at Week 24 and Week 48
time frame: Baseline (Day 1, Pre-dose), Week 24 and Week 48
description: Blood samples were collected from participants in fasting state to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Analysis was performed using multiple imputation with missing at random assumption. Only participants available at the time of evaluation were analyzed.
measure: Change From Baseline in Fasting Total Cholesterol/HDL Cholesterol Ratio
time frame: Baseline (Day 1, Pre-dose), Week 24 and Week 48
description: Blood samples were collected from participants in fasting state to evaluate total cholesterol/HDL cholesterol ratio. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Only participants available at the time of evaluation were analyzed. Analysis was performed using multiple imputation with missing at random assumption.
measure: Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol
time frame: Up to Week 48
description: Blood samples were collected from participants in fasting state at indicated time-points to evaluate LDL cholesterol. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in fasting LDL cholesterol was summarized. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.
measure: Number of Participants With Maximum Post-Baseline Emergent Grade 2 or Greater Drug-related Diarrhea
time frame: Week 24 and Week 48
description: Number of participants who experienced maximum grade 2 or greater toxicity post-Baseline in drug-related diarrhea was summarized. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. Participants were graded using the Division of AIDS Table for Grading Severity of Adult and Pediatric Adverse Events. Grade 1=mild; grade 2=moderate; grade 3=severe; grade 4=potentially life-threatening. Higher the grade, more severe the symptoms.
measure: Change From Baseline in Gastrointestinal Symptom Rating Scale (GSRS) Score
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48
description: The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea and Constipation. The scale ranges from 1= no discomfort to 7= very severe discomfort for each symptom cluster. Higher scores show greater severity of symptoms. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using Last Observation Carried Forward (LOCF) dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.
measure: Change From Baseline in Treatment Satisfaction, Using the HIV-Treatment Satisfaction Questionnaire (HIVTSQ) Score
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 24, Week 48
description: The HIVTSQ is a self-reported scales that measure overall satisfaction with treatment. The score ranges from 0-10. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Baseline was defined as the latest pre-dose assessment value. Change from Baseline was calculated as post-Baseline visit values minus Baseline value. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.
measure: Number of Participants Showing Adherence With Treatment, Using the Morisky 8-Item Medication Adherence Scale (MMAS-8)
time frame: Baseline (Day 1, Pre-dose), Week 4, Week 24 and Week 48
description: Treatment compliance was evaluated through MMAS-8. It is an eight-item self-reported measure of medication-taking behavior. The score ranges from 0-8 where scores of 8 indicate high or near perfect adherence, and scores of less than 6 indicate poor or inadequate adherence on the MMAS-8 scale. Number of participants showing low, medium and high adherence to treatment are presented. Low adherence is a score 0-5.75, medium adherence is a score of 6-7.75 and high adherence is a score of 8. The analysis was performed using LOCF dataset. In the LOCF dataset, missing values were carried forward from the previous, non-missing available on-treatment assessment.
arm group label: DTG arm
arm group type: Experimental
description: Subjects will receive one oral tablet of 50 mg DTG once daily plus two NRTIs selected by the investigator
arm group label: LPV/RTV arm
arm group type: Active Comparator
description: Subjects will receive four oral tablets of200/50 mg LPV/RTV once daily or two oral tablets of 200/50 mg LPV/RTV twice daily plus two NRTIs selected by the investigator
intervention type: Drug
intervention name: DTG
description: DTG is supplied as 50 mg tablets
arm group label: DTG arm
intervention type: Drug
intervention name: LPV/RTV
description: LPV/RTV is supplied as the LPV/RTV oral tablet, which contains 200 mg of LPV and 50 mg of RTV
arm group label: LPV/RTV arm
intervention type: Drug
intervention name: Two NRTIs
description: Investigators will choose a dual NRTI background regimen for each subject . In consultation with the medical monitor, 3TC may be added as a third NRTI to a dual-NRTI background regimen in subjects with chronic HBV infection and evidence of HIV resistance to 3TC
arm group label: DTG arm
arm group label: LPV/RTV arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: ViiV Healthcare
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country: Argentina
country: Brazil
country: Chile
country: China
country: Colombia
country: Kenya
country: Mexico
country: Peru
country: Romania
country: Russian Federation
country: South Africa
country: Thailand
country: Ukraine
citation: Aboud M, Kaplan R, Lombaard J, Zhang F, Hidalgo JA, Mamedova E, Losso MH, Chetchotisakd P, Brites C, Sievers J, Brown D, Hopking J, Underwood M, Nascimento MC, Punekar Y, Gartland M, Smith K. Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy in adults with HIV-1 infection in whom first-line therapy has failed (DAWNING): an open-label, non-inferiority, phase 3b trial. Lancet Infect Dis. 2019 Mar;19(3):253-264. doi: 10.1016/S1473-3099(19)30036-2. Epub 2019 Feb 4.
PMID: 30732940
citation: Underwood M, Horton J, Nangle K, Hopking J, Smith K, Aboud M, Wynne B, Sievers J, Stewart EL, Wang R. Integrase Inhibitor Resistance Mechanisms and Structural Characteristics in Antiretroviral Therapy-Experienced, Integrase Inhibitor-Naive Adults with HIV-1 Infection Treated with Dolutegravir plus Two Nucleoside Reverse Transcriptase Inhibitors in the DAWNING Study. Antimicrob Agents Chemother. 2022 Jan 18;66(1):e0164321. doi: 10.1128/AAC.01643-21. Epub 2021 Oct 25. Erratum In: Antimicrob Agents Chemother. 2023 Mar 16;67(3):e0032622.
PMID: 34694877
responsible party type: Sponsor
mesh term: HIV Infections
sharing ipd: Yes
ipd description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
ipd access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
ipd url: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/
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