<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/NCT03760458</url>
  </required_header>
  <id_info>
    <org_study_id>IMPAACT 2019</org_study_id>
    <secondary_id>38504</secondary_id>
    <nct_id>NCT03760458</nct_id>
  </id_info>
  <brief_title>The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age</brief_title>
  <official_title>Phase I/II Study of the Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>International Maternal Pediatric Adolescent AIDS Clinical Trials Group</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>ViiV Healthcare</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of&#xD;
      abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living&#xD;
      with HIV less than 12 years of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study examined the pharmacokinetics (PK), safety, and tolerability of fixed-dose&#xD;
      combination abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) dispersible and immediate&#xD;
      release tablets in children living with HIV less than 12 years of age.&#xD;
&#xD;
      Children were enrolled into one of five ABC/DTG/3TC dosing groups based on their weight. The&#xD;
      first 5-7 children within each weight-band underwent intensive PK assessments 5-10 days after&#xD;
      starting ABC/DTG/3TC to confirm dose selection. Children remained on their initial dose of&#xD;
      ABC/DTG/3TC through Week 4. After Week 4, ABC/DTG/3TC dosing was adjusted based on PK results&#xD;
      at the individual or weight-band level, and/or an individual child's growth and weight gain&#xD;
      over time.&#xD;
&#xD;
      Follow-up study visits for all participants occurred at Weeks 1, 4, 12, 24, 36, and 48. If&#xD;
      participants had a known M184 resistance mutation, they had additional study visits at Weeks&#xD;
      8, 16, and 20. Study visits included physical examination, study drug adherence and&#xD;
      tolerability questionnaires, blood collection, and intensive PK sampling. Following the Week&#xD;
      48 study visit, some children were allowed to continue follow-up through up to 144 weeks if&#xD;
      alternative post-study drug supply was not yet available.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 14, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC</measure>
    <time_frame>Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.</time_frame>
    <description>Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC</measure>
    <time_frame>Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.</time_frame>
    <description>Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC</measure>
    <time_frame>Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.</time_frame>
    <description>Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Had at Least One Adverse Event Through Week 24</measure>
    <time_frame>Measured from treatment initiation through Week 24</time_frame>
    <description>Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24</measure>
    <time_frame>Measured from treatment initiation through Week 24</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24</measure>
    <time_frame>Measured from treatment initiation through Week 24</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24</measure>
    <time_frame>Measured from treatment initiation through Week 24</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24</measure>
    <time_frame>Measured from treatment initiation through Week 24</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24</measure>
    <time_frame>Measured from treatment initiation through Week 24</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC</measure>
    <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
    <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC</measure>
    <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
    <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC</measure>
    <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
    <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC</measure>
    <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
    <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC</measure>
    <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
    <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC</measure>
    <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
    <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC</measure>
    <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
    <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With at Least One Adverse Event Through Week 48</measure>
    <time_frame>Measured from treatment initiation through Week 48</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48</measure>
    <time_frame>Measured from treatment initiation through Week 48</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48</measure>
    <time_frame>Measured from treatment initiation through Week 48</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48</measure>
    <time_frame>Measured from treatment initiation through Week 48</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48</measure>
    <time_frame>Measured from treatment initiation through Week 48</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48</measure>
    <time_frame>Measured from treatment initiation through Week 48</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Adverse Event Through Week 60</measure>
    <time_frame>Measured from treatment initiation through Week 60</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60</measure>
    <time_frame>Measured from treatment initiation through Week 60</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60</measure>
    <time_frame>Measured from treatment initiation through Week 60</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60</measure>
    <time_frame>Measured from treatment initiation through Week 60</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60</measure>
    <time_frame>Measured from treatment initiation through Week 60</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60</measure>
    <time_frame>Measured from treatment initiation through Week 60</time_frame>
    <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced Virologic Failure Through Week 48</measure>
    <time_frame>Measured from treatment initiation through Week 48</time_frame>
    <description>Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced Virologic Failure Through Week 60</measure>
    <time_frame>Measured from treatment initiation through Week 60</time_frame>
    <description>Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median (Q1, Q3) CD4+ Cell Count</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median (Q1, Q3) CD4+ Percentage</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median (Q1,Q3) Change From Baseline in Total Cholesterol</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median (Q1,Q3) Change From Baseline in HDL</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median (Q1,Q3) Change From Baseline in LDL</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median (Q1,Q3) Change From Baseline in Triglycerides</measure>
    <time_frame>Baseline, Weeks 24 and 48</time_frame>
    <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Percent Adherence to Study Drug</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Number of Missed Doses of Study Drug</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Reason for Missed Doses of Study Drug</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to</measure>
    <time_frame>Weeks 4, 24, and 48</time_frame>
    <description>Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Ease of Giving Study Drug</measure>
    <time_frame>Weeks 4, 12, 24, and 48</time_frame>
    <description>Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Response of Child's Face When Taking Study Drug</measure>
    <time_frame>Weeks 4, 12, 24, and 48</time_frame>
    <description>Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Response of Child's Face When Taking Favorite Food</measure>
    <time_frame>Weeks 4, 12, 24, and 48</time_frame>
    <description>Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Time for Study Drug Tablets to Dissolve</measure>
    <time_frame>Weeks 4, 12, 24, and 48</time_frame>
    <description>Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve</measure>
    <time_frame>Weeks 4, 12, 24, and 48</time_frame>
    <description>Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiretroviral (ARV) Resistance Mutations</measure>
    <time_frame>Entry and confirmation of virologic failure</time_frame>
    <description>ARV resistance mutations at time of virologic failure and at entry for children with virologic failure.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>HIV Infections</condition>
  <arm_group>
    <arm_group_label>Weight Band #1 (6 to less than 10 kg at study entry)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight Band #2 (10 to less than 14 kg at study entry)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight Band #3 (14 to less than 20 kg at study entry)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight Band #4 (20 to less than 25 kg at study entry)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weight Band #5 (25 kg or greater at study entry)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets</intervention_name>
    <description>Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
    <arm_group_label>Weight Band #1 (6 to less than 10 kg at study entry)</arm_group_label>
    <arm_group_label>Weight Band #2 (10 to less than 14 kg at study entry)</arm_group_label>
    <arm_group_label>Weight Band #3 (14 to less than 20 kg at study entry)</arm_group_label>
    <arm_group_label>Weight Band #4 (20 to less than 25 kg at study entry)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)</intervention_name>
    <description>Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
    <arm_group_label>Weight Band #5 (25 kg or greater at study entry)</arm_group_label>
    <other_name>Triumeq</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Weight 6 kg to less than 40 kg at entry&#xD;
&#xD;
          -  Antiretroviral therapy (ART)-naïve at entry or has been taking a stable ART regimen&#xD;
             for at least six consecutive months at entry&#xD;
&#xD;
               -  Note: For ART-naïve children, receipt of antiretroviral (ARV) prophylaxis prior&#xD;
                  to diagnosis of HIV infection is permitted. For these children, ascertainment of&#xD;
                  this criterion may be based on parent or guardian report only, but available&#xD;
                  medical records should also be reviewed in relation to this criterion.&#xD;
&#xD;
               -  Note: For ART-experienced children (on a stable ART regimen), dose and&#xD;
                  formulation changes (e.g., for growth) within the six months prior to entry are&#xD;
                  permitted. For these children, ascertainment of this criterion must be based on&#xD;
                  medical records.&#xD;
&#xD;
          -  For ART-experienced children (on a stable ART regimen), has had a suppressed HIV viral&#xD;
             load (HIV-1 RNA less than 200 copies/mL) for at least six consecutive months prior to&#xD;
             entry&#xD;
&#xD;
               -  Note: To fulfill this criterion, at least two documented HIV-1 RNA results less&#xD;
                  than 200 copies/mL must be available, one based on a specimen collected at least&#xD;
                  six months prior to entry and one based on a specimen collected within 30 days&#xD;
                  prior to entry.&#xD;
&#xD;
               -  Note: Any documented HIV-1 RNA result greater than or equal to 200 copies/mL&#xD;
                  based on a specimen collected within six months prior to entry is exclusionary&#xD;
                  (see exclusion criterion below).&#xD;
&#xD;
          -  At screening, has normal, Grade 1, or Grade 2 laboratory test results for all of the&#xD;
             following, based on testing of specimens collected within 30 days prior to entry and&#xD;
             grading per the Division of AIDS Table for Grading the Severity of Adult and Pediatric&#xD;
             Adverse Events (refer to the study protocol for guidance on severity grading):&#xD;
&#xD;
               -  Hemoglobin (greater than or equal to 8.5 g/dL or greater than or equal to 5.25&#xD;
                  mmol/L)&#xD;
&#xD;
               -  Absolute neutrophil count (greater than or equal to 600 cells/mm^3 or greater&#xD;
                  than or equal to 0.600 x 10^9 cells/L)&#xD;
&#xD;
               -  Platelet count (greater than or equal to 50,000 cells/mm^3 or greater than or&#xD;
                  equal to 50.00 x 10^9 cells/L)&#xD;
&#xD;
               -  Estimated glomerular filtration rate (eGFR; bedside Schwartz formula; greater&#xD;
                  than or equal to 60 ml/min/1.73 m^2)&#xD;
&#xD;
               -  Alanine transaminase (ALT) (less than 5.0 x ULN)&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) (less than 5.0 x ULN)&#xD;
&#xD;
               -  Total bilirubin (less than 2.6 x ULN)&#xD;
&#xD;
               -  Direct bilirubin (less than or equal to ULN)&#xD;
&#xD;
               -  Note: Laboratory tests may be repeated during the screening period (i.e., within&#xD;
                  30 days prior to entry), with the latest results used for eligibility&#xD;
                  determination.&#xD;
&#xD;
               -  Note: For treatment-experienced children on an atazanavir-containing ART regimen,&#xD;
                  Grade 3 or higher total bilirubin is permitted.&#xD;
&#xD;
          -  At screening, has a negative test result for hepatitis B surface antigen based on&#xD;
             testing of a specimen collected within 30 days prior to entry&#xD;
&#xD;
          -  Confirmed HIV-1-infection based on documented testing of two samples collected at&#xD;
             different time points:&#xD;
&#xD;
               -  Sample #1 may be tested using any of the following:&#xD;
&#xD;
                    -  Two rapid antibody tests from different manufacturers or based on different&#xD;
                       principles and epitopes&#xD;
&#xD;
                    -  One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR&#xD;
                       chemiluminescence assay&#xD;
&#xD;
                    -  One HIV DNA polymerase chain reaction (PCR)*&#xD;
&#xD;
                    -  One quantitative HIV RNA PCR (above the limit of detection of the assay)*&#xD;
&#xD;
                    -  One qualitative HIV RNA PCR*&#xD;
&#xD;
                    -  One HIV total nucleic acid test*&#xD;
&#xD;
               -  Sample #2 may be tested using any of the following:&#xD;
&#xD;
                    -  Rapid antibody test. If this option is used in combination with two rapid&#xD;
                       tests for Sample #1, at least one of the three rapid tests must be United&#xD;
                       States Food and Drug Administration (FDA)-approved, and the third rapid test&#xD;
                       must be from a third manufacturer or based on a third principle or epitope.&#xD;
&#xD;
                    -  One enzyme immunoassay OR Western Blot OR immunofluorescence assay OR&#xD;
                       chemiluminescence assay&#xD;
&#xD;
                    -  One HIV DNA PCR*&#xD;
&#xD;
                    -  One quantitative HIV RNA PCR (above the limit of detection of the assay)*&#xD;
&#xD;
                    -  One qualitative HIV RNA PCR*&#xD;
&#xD;
                    -  One HIV total nucleic acid test*&#xD;
&#xD;
               -  For participants who are less than two years of age, or who are two years of age&#xD;
                  and older with any exposure to breast milk in the past 28 days, HIV-1 infection&#xD;
                  must be confirmed using the tests indicated above with an asterisk (*) for Sample&#xD;
                  #1 and Sample #2.&#xD;
&#xD;
               -  Whole blood, plasma, or serum samples must be tested. If both samples are tested&#xD;
                  using antibody tests, at least one of the samples must be tested in a laboratory&#xD;
                  that operates according to Good Clinical Laboratory Practice guidelines and&#xD;
                  participates in an appropriate external quality assurance program. If nucleic&#xD;
                  acid testing is used, at least one test must be performed in a Clinical&#xD;
                  Laboratory Improvement Amendments (CLIA) certified (for US sites) or Virology&#xD;
                  Quality Assurance (VQA) certified (for non-US sites) laboratory. For tests&#xD;
                  performed in other settings, adequate source documentation including the date of&#xD;
                  specimen collection, date of testing, test performed, and test result must be&#xD;
                  available. FDA approved testing methods should be used when possible.&#xD;
&#xD;
          -  HLA-B*5701-negative based on documented testing at any time prior to entry&#xD;
&#xD;
               -  Note: Documented testing is required even if the potential participant has&#xD;
                  received ABC prior to study entry.&#xD;
&#xD;
          -  For females of reproductive potential (defined as having experienced menarche), not&#xD;
             pregnant based on testing performed at screening&#xD;
&#xD;
          -  For females of reproductive potential who are engaging in sexual activity that could&#xD;
             lead to pregnancy, willing to use two methods of contraception while receiving study&#xD;
             drug, based on participant and parent or guardian report at entry&#xD;
&#xD;
               -  One of the two methods must be highly effective; highly effective methods include&#xD;
                  surgical sterilization (i.e., hysterectomy, bilateral oophorectomy, tubal&#xD;
                  ligation, or salpingectomy) and the following:&#xD;
&#xD;
                    -  Contraceptive intrauterine device or intrauterine system&#xD;
&#xD;
                    -  Subdermal contraceptive implant&#xD;
&#xD;
                    -  Progestogen injections&#xD;
&#xD;
                    -  Combined estrogen and progestogen oral contraceptive pills&#xD;
&#xD;
                    -  Percutaneous contraceptive patch&#xD;
&#xD;
                    -  Contraceptive vaginal ring&#xD;
&#xD;
               -  The highly effective method must be initiated prior to study entry. The second&#xD;
                  method should ideally be a barrier method. Male or female condom use is&#xD;
                  recommended with all other methods of contraception for dual protection against&#xD;
                  pregnancy and to avoid transmission of HIV and other sexually transmitted&#xD;
                  infections.&#xD;
&#xD;
          -  Based on parent or guardian report at entry, child is expected to be available for 48&#xD;
             weeks of follow-up&#xD;
&#xD;
          -  Parent or legal guardian is willing and able to provide written informed consent for&#xD;
             child's study participation and, when applicable per local institutional review&#xD;
             board/ethics committee (IRB/EC) policies and procedures, child is willing and able to&#xD;
             provide written informed assent for study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented resistance to ABC, DTG, or 3TC&#xD;
&#xD;
               -  Note: Testing to rule out resistance is not required, and the M184V resistance&#xD;
                  mutation is not exclusionary.&#xD;
&#xD;
          -  For ART-experienced children (on a stable ART regimen), documented HIV-1 RNA result&#xD;
             greater than or equal to 200 copies/mL based on a specimen collected within six months&#xD;
             prior to entry&#xD;
&#xD;
          -  History of any of the following as determined by the site investigator based on&#xD;
             participant/parent/guardian report and available medical records:&#xD;
&#xD;
               -  Malignancy (ever)&#xD;
&#xD;
               -  Hypersensitivity reaction to ABC (ever)&#xD;
&#xD;
               -  Receipt of any prohibited medication (refer to the study protocol for more&#xD;
                  information) within 30 days prior to study entry&#xD;
&#xD;
               -  Receipt of systemic interferon or any chronic systemic immunosuppressant&#xD;
                  medication within 30 days prior to study entry&#xD;
&#xD;
               -  Note: Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg/kg)&#xD;
                  taken for replacement or short course therapy are permitted. Intranasal or&#xD;
                  inhaled steroid use is also permitted.&#xD;
&#xD;
          -  Has any of the following as determined by the site investigator based on&#xD;
             participant/parent/guardian report and available medical records&#xD;
&#xD;
               -  Current clinical evidence of pancreatitis&#xD;
&#xD;
               -  Currently-active tuberculosis (TB) and/or currently receiving&#xD;
                  rifampicin-containing TB treatment&#xD;
&#xD;
               -  Currently-active AIDS-defining (WHO Clinical Stage 4) opportunistic infection&#xD;
&#xD;
          -  Has any documented or suspected clinically significant medical condition or any other&#xD;
             condition that, in the opinion of the site investigator, would make participation in&#xD;
             the study unsafe, complicate interpretation of study outcome data, or otherwise&#xD;
             interfere with achieving the study objectives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia Flynn, MD</last_name>
    <role>Study Chair</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helena Rabie, MBChB, MMED, FCPaed</last_name>
    <role>Study Chair</role>
    <affiliation>University of Stellenbosch</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jennifer Kiser, PharmD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>David Geffen School of Medicine at UCLA NICHD CRS</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-1752</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. of Colorado Denver NICHD CRS</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush Univ. Cook County Hosp. Chicago NICHD CRS</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lurie Children's Hospital of Chicago (LCH) CRS</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60614-3393</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital CRS</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105-3678</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaborone CRS</name>
      <address>
        <city>Gaborone</city>
        <country>Botswana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Molepolole CRS</name>
      <address>
        <city>Gaborone</city>
        <country>Botswana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soweto IMPAACT CRS</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>1862</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wits RHI Shandukani Research Centre CRS</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umlazi CRS</name>
      <address>
        <city>Umlazi</city>
        <state>Kwa Zulu Natal</state>
        <zip>4066</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Famcru Crs</name>
      <address>
        <city>Tygerberg</city>
        <state>Western Cape Province</state>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siriraj Hospital, Mahidol University NICHD CRS</name>
      <address>
        <city>Bangkok</city>
        <state>Bangkoknoi</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiangrai Prachanukroh Hospital NICHD CRS</name>
      <address>
        <city>Changklan, Muang</city>
        <state>Chiang Mai</state>
        <zip>50100</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Botswana</country>
    <country>South Africa</country>
    <country>Thailand</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables</url>
    <description>The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1 (July 2017)</description>
  </link>
  <link>
    <url>http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids</url>
    <description>Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010</description>
  </link>
  <link>
    <url>https://www.fda.gov/files/drugs/published/Human-Immunodeficiency-Virus-1-Infection--Developing-Antiretroviral-Drugs-for-Treatment.pdf</url>
    <description>FDA Snapshot Algorithm</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>December 9, 2022</results_first_submitted>
  <results_first_submitted_qc>January 18, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 13, 2023</results_first_posted>
  <last_update_submitted>May 30, 2023</last_update_submitted>
  <last_update_submitted_qc>May 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>HIV Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lamivudine</mesh_term>
    <mesh_term>Abacavir</mesh_term>
    <mesh_term>Dideoxynucleosides</mesh_term>
    <mesh_term>Dolutegravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie results in the publication, after deidentification.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.</ipd_time_frame>
    <ipd_access_criteria>With whom?&#xD;
Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.&#xD;
For what types of analyses?&#xD;
To achieve aims in the proposal approved by the IMPAACT Network.&#xD;
By what mechanism will data be made available?&#xD;
Researchers may submit a request for access to data using the IMPAACT &quot;Data Request&quot; form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.</ipd_access_criteria>
  </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>August 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03760458/Prot_000.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>December 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03760458/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Accrual occurred between September 2020 and June 2021 in Botswana, South Africa, Thailand, and the United States at 14 different medical clinic sites.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
          <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="P2">
          <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
          <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="P3">
          <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
          <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="P4">
          <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
          <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="P5">
          <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
          <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Main Study (Through Week 48)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Extended Follow-up (Weeks 48 Through 60)</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="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
              </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="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="3"/>
              </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="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled participants</population>
      <group_list>
        <group group_id="B1">
          <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
          <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="B2">
          <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
          <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="B3">
          <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
          <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="B4">
          <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
          <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="B5">
          <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
          <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
        </group>
        <group group_id="B6">
          <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="9"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="11"/>
            <count group_id="B6" value="57"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.35" lower_limit="0.98" upper_limit="2.02"/>
                    <measurement group_id="B2" value="3.56" lower_limit="1.51" upper_limit="4.51"/>
                    <measurement group_id="B3" value="6.44" lower_limit="3.88" upper_limit="9.58"/>
                    <measurement group_id="B4" value="8.41" lower_limit="6.38" upper_limit="8.91"/>
                    <measurement group_id="B5" value="9.74" lower_limit="8.68" upper_limit="11.28"/>
                    <measurement group_id="B6" value="6.38" lower_limit="0.98" upper_limit="11.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;6 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 to &lt;12 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="29"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Botswana</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Africa</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thailand</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kilograms</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.2" lower_limit="8.5" upper_limit="9.5"/>
                    <measurement group_id="B2" value="12.9" lower_limit="12.5" upper_limit="13.7"/>
                    <measurement group_id="B3" value="17.0" lower_limit="15.9" upper_limit="18.8"/>
                    <measurement group_id="B4" value="21.5" lower_limit="21.0" upper_limit="23.3"/>
                    <measurement group_id="B5" value="28.5" lower_limit="26.0" upper_limit="35.6"/>
                    <measurement group_id="B6" value="17.0" lower_limit="12.8" upper_limit="22.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-study Antiretroviral (ART) experience</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ART-experienced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ART-naive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Known M184V mutation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>HIV-1 RNA</title>
          <description>Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;200 copies/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="11"/>
                    <measurement group_id="B6" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥200 copies/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4+ Cell Count</title>
          <population>CD4 was not collected at baseline for one participant in Weight Band #2.</population>
          <units>cells/mm^3</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2321" lower_limit="1390" upper_limit="3514"/>
                    <measurement group_id="B2" value="1452" lower_limit="1161" upper_limit="2615"/>
                    <measurement group_id="B3" value="886" lower_limit="761" upper_limit="1412"/>
                    <measurement group_id="B4" value="1155" lower_limit="801" upper_limit="1251"/>
                    <measurement group_id="B5" value="915" lower_limit="753" upper_limit="1450"/>
                    <measurement group_id="B6" value="1201" lower_limit="880" upper_limit="1535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CD4+ Percentage</title>
          <population>CD4/Lymphocytes was not collected at baseline for one participant in Weight Band #2.</population>
          <units>percentage of CD4+ in total lymphocytes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="11"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.0" lower_limit="32.3" upper_limit="49.1"/>
                    <measurement group_id="B2" value="33.9" lower_limit="31.6" upper_limit="45.6"/>
                    <measurement group_id="B3" value="32.9" lower_limit="31.6" upper_limit="39.2"/>
                    <measurement group_id="B4" value="32.6" lower_limit="26.2" upper_limit="43.0"/>
                    <measurement group_id="B5" value="37.7" lower_limit="35.6" upper_limit="43.0"/>
                    <measurement group_id="B6" value="35.1" lower_limit="31.9" upper_limit="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Cholesterol</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.01" lower_limit="3.19" upper_limit="4.82"/>
                    <measurement group_id="B2" value="4.61" lower_limit="3.39" upper_limit="5.11"/>
                    <measurement group_id="B3" value="4.51" lower_limit="3.70" upper_limit="5.20"/>
                    <measurement group_id="B4" value="5.19" lower_limit="3.86" upper_limit="5.90"/>
                    <measurement group_id="B5" value="4.27" lower_limit="3.25" upper_limit="5.72"/>
                    <measurement group_id="B6" value="4.51" lower_limit="3.57" upper_limit="5.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>High-Density Lipoprotein (HDL) Cholesterol</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.98" lower_limit="0.96" upper_limit="1.18"/>
                    <measurement group_id="B2" value="1.53" lower_limit="1.29" upper_limit="1.63"/>
                    <measurement group_id="B3" value="1.38" lower_limit="1.24" upper_limit="1.79"/>
                    <measurement group_id="B4" value="1.67" lower_limit="1.14" upper_limit="2.00"/>
                    <measurement group_id="B5" value="1.34" lower_limit="1.13" upper_limit="1.53"/>
                    <measurement group_id="B6" value="1.37" lower_limit="1.1914" upper_limit="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Low-Density Lipoprotein (LDL) Cholesterol</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.52" lower_limit="1.92" upper_limit="3.20"/>
                    <measurement group_id="B2" value="2.25" lower_limit="2.00" upper_limit="3.01"/>
                    <measurement group_id="B3" value="2.50" lower_limit="1.94" upper_limit="3.03"/>
                    <measurement group_id="B4" value="3.04" lower_limit="2.31" upper_limit="3.55"/>
                    <measurement group_id="B5" value="2.36" lower_limit="1.79" upper_limit="3.09"/>
                    <measurement group_id="B6" value="2.52" lower_limit="1.93" upper_limit="3.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Triglycerides</title>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="15"/>
                    <count group_id="B4" value="10"/>
                    <count group_id="B5" value="11"/>
                    <count group_id="B6" value="57"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.71" lower_limit="1.04" upper_limit="2.00"/>
                    <measurement group_id="B2" value="1.20" lower_limit="0.94" upper_limit="1.75"/>
                    <measurement group_id="B3" value="1.23" lower_limit="0.90" upper_limit="1.57"/>
                    <measurement group_id="B4" value="1.08" lower_limit="0.81" upper_limit="1.32"/>
                    <measurement group_id="B5" value="1.76" lower_limit="0.75" upper_limit="2.88"/>
                    <measurement group_id="B6" value="1.20" lower_limit="0.90" upper_limit="1.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC</title>
        <description>Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
        <time_frame>Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.</time_frame>
        <population>Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC</title>
          <description>Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
          <population>Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.</population>
          <units>h*ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abacavir (ABC)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.7" spread="33.8"/>
                    <measurement group_id="O2" value="19.8" spread="50.6"/>
                    <measurement group_id="O3" value="15.1" spread="40.3"/>
                    <measurement group_id="O4" value="17.4" spread="19.4"/>
                    <measurement group_id="O5" value="25.7" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dolutegravir (DTG)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.9" spread="33.7"/>
                    <measurement group_id="O2" value="91.0" spread="36.5"/>
                    <measurement group_id="O3" value="71.4" spread="23.5"/>
                    <measurement group_id="O4" value="84.4" spread="26.3"/>
                    <measurement group_id="O5" value="71.8" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lamivudine (3TC)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="46.0"/>
                    <measurement group_id="O2" value="14.2" spread="23.9"/>
                    <measurement group_id="O3" value="13.0" spread="15.6"/>
                    <measurement group_id="O4" value="14.5" spread="16.6"/>
                    <measurement group_id="O5" value="21.7" spread="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC</title>
        <description>Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
        <time_frame>Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.</time_frame>
        <population>Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC</title>
          <description>Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
          <population>Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.30" spread="20.5"/>
                    <measurement group_id="O2" value="8.36" spread="43.7"/>
                    <measurement group_id="O3" value="6.26" spread="31.0"/>
                    <measurement group_id="O4" value="6.65" spread="27.7"/>
                    <measurement group_id="O5" value="9.04" spread="21.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.40" spread="28.0"/>
                    <measurement group_id="O2" value="8.85" spread="21.3"/>
                    <measurement group_id="O3" value="7.04" spread="17.0"/>
                    <measurement group_id="O4" value="7.29" spread="16.7"/>
                    <measurement group_id="O5" value="6.25" spread="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" spread="39.8"/>
                    <measurement group_id="O2" value="3.55" spread="18.7"/>
                    <measurement group_id="O3" value="2.92" spread="23.0"/>
                    <measurement group_id="O4" value="2.99" spread="31.9"/>
                    <measurement group_id="O5" value="4.15" spread="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC</title>
        <description>Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
        <time_frame>Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.</time_frame>
        <population>Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC</title>
          <description>Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.</description>
          <population>Participants receiving treatment at timepoint who received treatment for their enrollment weight band through the intensive PK collection, and through either the Week 4 visit or the occurrence of an adverse event prior to the Week 4 visit that 1) was grade 3 or higher and assessed as related to study drug, or 2) resulted in premature discontinuation of study drug.</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.003" spread="127.6"/>
                    <measurement group_id="O2" value="0.005" spread="127.4"/>
                    <measurement group_id="O3" value="0.003" spread="107.5"/>
                    <measurement group_id="O4" value="0.004" spread="84.9"/>
                    <measurement group_id="O5" value="0.011" spread="228.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.91" spread="67.6"/>
                    <measurement group_id="O2" value="1.22" spread="77.5"/>
                    <measurement group_id="O3" value="0.79" spread="44.2"/>
                    <measurement group_id="O4" value="1.35" spread="95.5"/>
                    <measurement group_id="O5" value="0.98" spread="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.055" spread="39.5"/>
                    <measurement group_id="O2" value="0.046" spread="48.3"/>
                    <measurement group_id="O3" value="0.058" spread="36.7"/>
                    <measurement group_id="O4" value="0.060" spread="18.3"/>
                    <measurement group_id="O5" value="0.084" spread="35.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had at Least One Adverse Event Through Week 24</title>
        <description>Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
        <time_frame>Measured from treatment initiation through Week 24</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Adverse Event Through Week 24</title>
          <description>Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="63.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="90.9" lower_limit="58.7" upper_limit="99.8"/>
                    <measurement group_id="O3" value="100.0" lower_limit="78.2" upper_limit="100.0"/>
                    <measurement group_id="O4" value="80.0" lower_limit="44.4" upper_limit="97.5"/>
                    <measurement group_id="O5" value="80.0" lower_limit="44.4" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 24</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 24</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).</description>
        <time_frame>Measured from treatment initiation through Week 24</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
        <time_frame>Measured from treatment initiation through Week 24</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 24</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC</title>
        <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
        <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
        <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC</title>
          <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
          <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
          <units>ug*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.30" lower_limit="12" upper_limit="25.1"/>
                    <measurement group_id="O2" value="18.90" lower_limit="14.7" upper_limit="24.2"/>
                    <measurement group_id="O3" value="17.20" lower_limit="14.8" upper_limit="20"/>
                    <measurement group_id="O4" value="19.50" lower_limit="16.6" upper_limit="22.9"/>
                    <measurement group_id="O5" value="26.10" lower_limit="22.5" upper_limit="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.20" lower_limit="65.6" upper_limit="103"/>
                    <measurement group_id="O2" value="86.90" lower_limit="75.3" upper_limit="100"/>
                    <measurement group_id="O3" value="71.50" lower_limit="62.1" upper_limit="82.2"/>
                    <measurement group_id="O4" value="81.60" lower_limit="70.8" upper_limit="94.2"/>
                    <measurement group_id="O5" value="72.60" lower_limit="64.9" upper_limit="81.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.97" lower_limit="7.12" upper_limit="14"/>
                    <measurement group_id="O2" value="14.90" lower_limit="10.6" upper_limit="20.9"/>
                    <measurement group_id="O3" value="13.60" lower_limit="11.6" upper_limit="15.8"/>
                    <measurement group_id="O4" value="13.10" lower_limit="11.2" upper_limit="15.2"/>
                    <measurement group_id="O5" value="20.30" lower_limit="16.9" upper_limit="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC</title>
        <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
        <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
        <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC</title>
          <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
          <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" lower_limit="0.002" upper_limit="0.021"/>
                    <measurement group_id="O2" value="0.02" lower_limit="0.007" upper_limit="0.042"/>
                    <measurement group_id="O3" value="0.01" lower_limit="0.008" upper_limit="0.021"/>
                    <measurement group_id="O4" value="0.01" lower_limit="0.004" upper_limit="0.015"/>
                    <measurement group_id="O5" value="0.02" lower_limit="0.010" upper_limit="0.038"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" lower_limit="0.67" upper_limit="1.74"/>
                    <measurement group_id="O2" value="1.35" lower_limit="1.01" upper_limit="1.82"/>
                    <measurement group_id="O3" value="0.71" lower_limit="0.478" upper_limit="1.05"/>
                    <measurement group_id="O4" value="1.09" lower_limit="0.761" upper_limit="1.56"/>
                    <measurement group_id="O5" value="1.01" lower_limit="0.772" upper_limit="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" lower_limit="0.003" upper_limit="0.015"/>
                    <measurement group_id="O2" value="0.03" lower_limit="0.01" upper_limit="0.085"/>
                    <measurement group_id="O3" value="0.02" lower_limit="0.006" upper_limit="0.04"/>
                    <measurement group_id="O4" value="0.01" lower_limit="0.003" upper_limit="0.028"/>
                    <measurement group_id="O5" value="0.02" lower_limit="0.008" upper_limit="0.074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC</title>
        <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
        <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
        <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC</title>
          <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
          <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included.</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" lower_limit="0.003" upper_limit="0.018"/>
                    <measurement group_id="O2" value="0.02" lower_limit="0.007" upper_limit="0.042"/>
                    <measurement group_id="O3" value="0.01" lower_limit="0.007" upper_limit="0.024"/>
                    <measurement group_id="O4" value="0.01" lower_limit="0.004" upper_limit="0.018"/>
                    <measurement group_id="O5" value="0.02" lower_limit="0.010" upper_limit="0.040"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" lower_limit="0.67" upper_limit="1.74"/>
                    <measurement group_id="O2" value="1.35" lower_limit="1.01" upper_limit="1.82"/>
                    <measurement group_id="O3" value="0.71" lower_limit="0.48" upper_limit="1.05"/>
                    <measurement group_id="O4" value="1.09" lower_limit="0.76" upper_limit="1.56"/>
                    <measurement group_id="O5" value="1.01" lower_limit="0.77" upper_limit="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" lower_limit="0.004" upper_limit="0.047"/>
                    <measurement group_id="O2" value="0.02" lower_limit="0.005" upper_limit="0.053"/>
                    <measurement group_id="O3" value="0.01" lower_limit="0.005" upper_limit="0.021"/>
                    <measurement group_id="O4" value="0.02" lower_limit="0.007" upper_limit="0.043"/>
                    <measurement group_id="O5" value="0.03" lower_limit="0.008" upper_limit="0.081"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC</title>
        <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
        <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
        <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC</title>
          <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
          <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
          <units>ug/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.04" lower_limit="4.29" upper_limit="8.51"/>
                    <measurement group_id="O2" value="7.42" lower_limit="5.75" upper_limit="9.57"/>
                    <measurement group_id="O3" value="7.07" lower_limit="5.73" upper_limit="8.73"/>
                    <measurement group_id="O4" value="8.04" lower_limit="6.27" upper_limit="10.3"/>
                    <measurement group_id="O5" value="9.60" lower_limit="8.03" upper_limit="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.79" lower_limit="5.92" upper_limit="7.8"/>
                    <measurement group_id="O2" value="6.63" lower_limit="5.96" upper_limit="7.37"/>
                    <measurement group_id="O3" value="6.36" lower_limit="5.9" upper_limit="6.85"/>
                    <measurement group_id="O4" value="6.59" lower_limit="6.13" upper_limit="7.09"/>
                    <measurement group_id="O5" value="5.43" lower_limit="4.91" upper_limit="6.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.29" lower_limit="1.82" upper_limit="2.88"/>
                    <measurement group_id="O2" value="2.64" lower_limit="2.12" upper_limit="3.29"/>
                    <measurement group_id="O3" value="2.98" lower_limit="2.65" upper_limit="3.35"/>
                    <measurement group_id="O4" value="2.65" lower_limit="2.16" upper_limit="3.25"/>
                    <measurement group_id="O5" value="3.59" lower_limit="2.89" upper_limit="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC</title>
        <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
        <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
        <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC</title>
          <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
          <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O3" value="1.00" lower_limit="1.00" upper_limit="2.00"/>
                    <measurement group_id="O4" value="1.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O5" value="1.00" lower_limit="1.00" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="2.00" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O3" value="2.00" lower_limit="2.00" upper_limit="4.00"/>
                    <measurement group_id="O4" value="2.50" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="3.00" lower_limit="2.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="2.00" lower_limit="1.00" upper_limit="8.00"/>
                    <measurement group_id="O3" value="2.00" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O4" value="2.00" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="2.00" lower_limit="2.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC</title>
        <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
        <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
        <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC</title>
          <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
          <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
          <units>L/hour</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.40" lower_limit="7.16" upper_limit="15.1"/>
                    <measurement group_id="O2" value="12.70" lower_limit="9.92" upper_limit="16.3"/>
                    <measurement group_id="O3" value="17.40" lower_limit="15" upper_limit="20.2"/>
                    <measurement group_id="O4" value="18.40" lower_limit="15.7" upper_limit="21.7"/>
                    <measurement group_id="O5" value="23.00" lower_limit="19.8" upper_limit="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" lower_limit="0.15" upper_limit="0.23"/>
                    <measurement group_id="O2" value="0.23" lower_limit="0.20" upper_limit="0.27"/>
                    <measurement group_id="O3" value="0.35" lower_limit="0.30" upper_limit="0.40"/>
                    <measurement group_id="O4" value="0.37" lower_limit="0.32" upper_limit="0.42"/>
                    <measurement group_id="O5" value="0.69" lower_limit="0.62" upper_limit="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.03" lower_limit="6.45" upper_limit="12.6"/>
                    <measurement group_id="O2" value="8.04" lower_limit="5.74" upper_limit="11.3"/>
                    <measurement group_id="O3" value="11.00" lower_limit="9.46" upper_limit="12.9"/>
                    <measurement group_id="O4" value="13.80" lower_limit="11.8" upper_limit="16"/>
                    <measurement group_id="O5" value="14.80" lower_limit="12.3" upper_limit="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC</title>
        <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
        <time_frame>Measured from Week 1 through Week 48 over 24 hours post-dose</time_frame>
        <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC</title>
          <description>Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.</description>
          <population>All participants with intensive or sparse PK results at the recommended doses according to their enrollment weight band. Two participants who discontinued the study in the first week were not included</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ABC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.21" lower_limit="2.54" upper_limit="4.07"/>
                    <measurement group_id="O2" value="3.43" lower_limit="2.71" upper_limit="4.34"/>
                    <measurement group_id="O3" value="3.72" lower_limit="3.19" upper_limit="4.33"/>
                    <measurement group_id="O4" value="3.32" lower_limit="2.75" upper_limit="4.01"/>
                    <measurement group_id="O5" value="3.30" lower_limit="2.75" upper_limit="3.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DTG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.34" lower_limit="6.68" upper_limit="10.4"/>
                    <measurement group_id="O2" value="9.42" lower_limit="7.91" upper_limit="11.2"/>
                    <measurement group_id="O3" value="6.75" lower_limit="5.82" upper_limit="7.83"/>
                    <measurement group_id="O4" value="8.34" lower_limit="6.72" upper_limit="10.4"/>
                    <measurement group_id="O5" value="8.14" lower_limit="7" upper_limit="9.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3TC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.38" lower_limit="2.54" upper_limit="4.48"/>
                    <measurement group_id="O2" value="3.23" lower_limit="2.5" upper_limit="4.16"/>
                    <measurement group_id="O3" value="2.97" lower_limit="2.52" upper_limit="3.49"/>
                    <measurement group_id="O4" value="3.46" lower_limit="2.64" upper_limit="4.52"/>
                    <measurement group_id="O5" value="3.51" lower_limit="2.64" upper_limit="4.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With at Least One Adverse Event Through Week 48</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
        <time_frame>Measured from treatment initiation through Week 48</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With at Least One Adverse Event Through Week 48</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="63.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="90.9" lower_limit="58.7" upper_limit="99.8"/>
                    <measurement group_id="O3" value="100.0" lower_limit="78.2" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="69.2" upper_limit="100.0"/>
                    <measurement group_id="O5" value="90.0" lower_limit="55.5" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 48</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="20.0" lower_limit="2.5" upper_limit="55.6"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 48</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
        <time_frame>Measured from treatment initiation through Week 48</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
        <time_frame>Measured from treatment initiation through Week 48</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 48</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Adverse Event Through Week 60</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
        <time_frame>Measured from treatment initiation through Week 60</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Adverse Event Through Week 60</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="63.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="90.9" lower_limit="58.7" upper_limit="99.8"/>
                    <measurement group_id="O3" value="100.0" lower_limit="78.2" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="69.2" upper_limit="100.0"/>
                    <measurement group_id="O5" value="90.0" lower_limit="55.5" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 60</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="20.0" lower_limit="2.5" upper_limit="55.6"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 60</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
        <time_frame>Measured from treatment initiation through Week 60</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
        <time_frame>Measured from treatment initiation through Week 60</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60</title>
        <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
        <time_frame>Measured from treatment initiation through Week 60</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60</title>
          <description>AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O4" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experienced Virologic Failure Through Week 48</title>
        <description>Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.</description>
        <time_frame>Measured from treatment initiation through Week 48</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced Virologic Failure Through Week 48</title>
          <description>Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ART-experienced</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ART-naive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experienced Virologic Failure Through Week 60</title>
        <description>Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.</description>
        <time_frame>Measured from treatment initiation through Week 60</time_frame>
        <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced Virologic Failure Through Week 60</title>
          <description>Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.</description>
          <population>All participants who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ART-experienced</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ART-naive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL</title>
        <description>Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24. One participant in Weight Band #4 discontinued study treatment between Weeks 24 and 48, so this participant was excluded from analysis at Week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL</title>
          <description>Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
          <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24. One participant in Weight Band #4 discontinued study treatment between Weeks 24 and 48, so this participant was excluded from analysis at Week 48.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.5"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                    <measurement group_id="O3" value="100.0"/>
                    <measurement group_id="O4" value="100.0"/>
                    <measurement group_id="O5" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm</title>
        <description>Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm</title>
          <description>Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
          <population>All participants who received at least one dose of study treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="29.9" upper_limit="92.5"/>
                    <measurement group_id="O2" value="100.0" lower_limit="73.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="78.2" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="69.2" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="71.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" lower_limit="40.0" upper_limit="97.2"/>
                    <measurement group_id="O2" value="91.7" lower_limit="61.5" upper_limit="99.8"/>
                    <measurement group_id="O3" value="100.0" lower_limit="78.2" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="69.2" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="71.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" lower_limit="51.8" upper_limit="99.7"/>
                    <measurement group_id="O2" value="91.7" lower_limit="61.5" upper_limit="99.8"/>
                    <measurement group_id="O3" value="100.0" lower_limit="78.2" upper_limit="100.0"/>
                    <measurement group_id="O4" value="90.0" lower_limit="55.5" upper_limit="99.7"/>
                    <measurement group_id="O5" value="100.0" lower_limit="71.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm</title>
        <description>Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm</title>
          <description>Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.</description>
          <population>All participants who received at least one dose of study treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4" lower_limit="13.7" upper_limit="78.8"/>
                    <measurement group_id="O2" value="91.7" lower_limit="61.5" upper_limit="99.8"/>
                    <measurement group_id="O3" value="86.7" lower_limit="59.5" upper_limit="98.3"/>
                    <measurement group_id="O4" value="80.0" lower_limit="44.4" upper_limit="97.5"/>
                    <measurement group_id="O5" value="100.0" lower_limit="71.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" lower_limit="40.0" upper_limit="97.2"/>
                    <measurement group_id="O2" value="83.3" lower_limit="51.6" upper_limit="97.9"/>
                    <measurement group_id="O3" value="93.3" lower_limit="68.1" upper_limit="99.8"/>
                    <measurement group_id="O4" value="100.0" lower_limit="69.2" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="71.5" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" lower_limit="40.0" upper_limit="97.2"/>
                    <measurement group_id="O2" value="66.7" lower_limit="34.9" upper_limit="90.1"/>
                    <measurement group_id="O3" value="86.7" lower_limit="59.5" upper_limit="98.3"/>
                    <measurement group_id="O4" value="70.0" lower_limit="34.8" upper_limit="93.3"/>
                    <measurement group_id="O5" value="90.9" lower_limit="58.7" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median (Q1, Q3) CD4+ Cell Count</title>
        <description>Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Median (Q1, Q3) CD4+ Cell Count</title>
          <description>Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.</description>
          <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3528" lower_limit="1458" upper_limit="4457"/>
                    <measurement group_id="O2" value="1385" lower_limit="1020" upper_limit="1761"/>
                    <measurement group_id="O3" value="812" lower_limit="716" upper_limit="1164"/>
                    <measurement group_id="O4" value="992" lower_limit="930" upper_limit="1408"/>
                    <measurement group_id="O5" value="841" lower_limit="627" upper_limit="1238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2208" lower_limit="1302" upper_limit="2939"/>
                    <measurement group_id="O2" value="1184" lower_limit="987" upper_limit="1810"/>
                    <measurement group_id="O3" value="894" lower_limit="689" upper_limit="1250"/>
                    <measurement group_id="O4" value="944" lower_limit="774" upper_limit="1047"/>
                    <measurement group_id="O5" value="920" lower_limit="675" upper_limit="1188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1853" lower_limit="1287" upper_limit="2700"/>
                    <measurement group_id="O2" value="1235" lower_limit="889" upper_limit="1591"/>
                    <measurement group_id="O3" value="930" lower_limit="791" upper_limit="1274"/>
                    <measurement group_id="O4" value="942" lower_limit="765" upper_limit="1194"/>
                    <measurement group_id="O5" value="777" lower_limit="681" upper_limit="825"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median (Q1, Q3) CD4+ Percentage</title>
        <description>Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Median (Q1, Q3) CD4+ Percentage</title>
          <description>Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.</description>
          <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>percentage of CD4+ in total lymphocytes</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.6" lower_limit="31.4" upper_limit="43.6"/>
                    <measurement group_id="O2" value="33.9" lower_limit="30.2" upper_limit="39.5"/>
                    <measurement group_id="O3" value="32.4" lower_limit="27.8" upper_limit="39.7"/>
                    <measurement group_id="O4" value="34.4" lower_limit="30.0" upper_limit="41.0"/>
                    <measurement group_id="O5" value="39.5" lower_limit="38.2" upper_limit="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.6" lower_limit="29.3" upper_limit="40.3"/>
                    <measurement group_id="O2" value="35.2" lower_limit="27.3" upper_limit="40.0"/>
                    <measurement group_id="O3" value="33.5" lower_limit="25.9" upper_limit="40.1"/>
                    <measurement group_id="O4" value="37.7" lower_limit="27.0" upper_limit="42.0"/>
                    <measurement group_id="O5" value="38.6" lower_limit="36.0" upper_limit="44.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8" lower_limit="29.5" upper_limit="42.6"/>
                    <measurement group_id="O2" value="34.1" lower_limit="26.7" upper_limit="39.9"/>
                    <measurement group_id="O3" value="30.5" lower_limit="29.3" upper_limit="41.0"/>
                    <measurement group_id="O4" value="33.5" lower_limit="28.5" upper_limit="37.0"/>
                    <measurement group_id="O5" value="37.6" lower_limit="34.0" upper_limit="41.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median (Q1,Q3) Change From Baseline in Total Cholesterol</title>
        <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
        <time_frame>Baseline, Weeks 24 and 48</time_frame>
        <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Median (Q1,Q3) Change From Baseline in Total Cholesterol</title>
          <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
          <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>mmol/L</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.31" lower_limit="-0.84" upper_limit="0.68"/>
                    <measurement group_id="O2" value="-0.70" lower_limit="-1.40" upper_limit="0.49"/>
                    <measurement group_id="O3" value="-0.67" lower_limit="-0.94" upper_limit="0.16"/>
                    <measurement group_id="O4" value="-0.32" lower_limit="-0.65" upper_limit="0.34"/>
                    <measurement group_id="O5" value="-0.18" lower_limit="-0.67" upper_limit="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" lower_limit="-0.84" upper_limit="0.67"/>
                    <measurement group_id="O2" value="-0.50" lower_limit="-1.30" upper_limit="0.01"/>
                    <measurement group_id="O3" value="-0.68" lower_limit="-1.10" upper_limit="-0.39"/>
                    <measurement group_id="O4" value="-0.25" lower_limit="-0.73" upper_limit="0.23"/>
                    <measurement group_id="O5" value="-0.09" lower_limit="-0.39" upper_limit="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median (Q1,Q3) Change From Baseline in HDL</title>
        <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
        <time_frame>Baseline, Weeks 24 and 48</time_frame>
        <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Median (Q1,Q3) Change From Baseline in HDL</title>
          <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
          <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>mmol/L</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" lower_limit="-0.21" upper_limit="0.24"/>
                    <measurement group_id="O2" value="-0.06" lower_limit="-0.40" upper_limit="0.10"/>
                    <measurement group_id="O3" value="-0.19" lower_limit="-0.30" upper_limit="0.00"/>
                    <measurement group_id="O4" value="-0.15" lower_limit="-0.40" upper_limit="0.20"/>
                    <measurement group_id="O5" value="-0.06" lower_limit="-0.18" upper_limit="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" lower_limit="-0.26" upper_limit="0.18"/>
                    <measurement group_id="O2" value="-0.20" lower_limit="-0.30" upper_limit="0.10"/>
                    <measurement group_id="O3" value="-0.24" lower_limit="-0.37" upper_limit="-0.08"/>
                    <measurement group_id="O4" value="-0.19" lower_limit="-0.50" upper_limit="0.33"/>
                    <measurement group_id="O5" value="0.05" lower_limit="-0.01" upper_limit="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median (Q1,Q3) Change From Baseline in LDL</title>
        <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
        <time_frame>Baseline, Weeks 24 and 48</time_frame>
        <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Median (Q1,Q3) Change From Baseline in LDL</title>
          <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
          <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>mmol/L</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" lower_limit="-0.78" upper_limit="0.52"/>
                    <measurement group_id="O2" value="-0.20" lower_limit="-0.70" upper_limit="0.31"/>
                    <measurement group_id="O3" value="-0.26" lower_limit="-0.70" upper_limit="0.11"/>
                    <measurement group_id="O4" value="-0.22" lower_limit="-0.60" upper_limit="0.25"/>
                    <measurement group_id="O5" value="-0.21" lower_limit="-0.73" upper_limit="-0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" lower_limit="-0.52" upper_limit="1.14"/>
                    <measurement group_id="O2" value="-0.13" lower_limit="-1.20" upper_limit="0.42"/>
                    <measurement group_id="O3" value="-0.30" lower_limit="-0.60" upper_limit="0.10"/>
                    <measurement group_id="O4" value="0.00" lower_limit="-0.18" upper_limit="0.13"/>
                    <measurement group_id="O5" value="0.03" lower_limit="-0.41" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median (Q1,Q3) Change From Baseline in Triglycerides</title>
        <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
        <time_frame>Baseline, Weeks 24 and 48</time_frame>
        <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Median (Q1,Q3) Change From Baseline in Triglycerides</title>
          <description>Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.</description>
          <population>All participants taking treatment at timepoint who started treatment for their enrollment weight band and whose dose may have been increased to a higher weight band due to weight gain, who either completed treatment through Week 24 or discontinued treatment due to toxicity prior to Week 24.</population>
          <units>mmol/L</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.51" lower_limit="-1.28" upper_limit="0.06"/>
                    <measurement group_id="O2" value="-0.51" lower_limit="-0.80" upper_limit="-0.13"/>
                    <measurement group_id="O3" value="-0.17" lower_limit="-0.58" upper_limit="0.32"/>
                    <measurement group_id="O4" value="-0.20" lower_limit="-0.38" upper_limit="0.16"/>
                    <measurement group_id="O5" value="-0.24" lower_limit="-0.73" upper_limit="0.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" lower_limit="-0.97" upper_limit="0.07"/>
                    <measurement group_id="O2" value="-0.32" lower_limit="-0.90" upper_limit="0.30"/>
                    <measurement group_id="O3" value="-0.21" lower_limit="-0.60" upper_limit="0.20"/>
                    <measurement group_id="O4" value="0.00" lower_limit="-0.31" upper_limit="0.10"/>
                    <measurement group_id="O5" value="-0.27" lower_limit="-1.27" upper_limit="-0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Percent Adherence to Study Drug</title>
        <description>Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Percent Adherence to Study Drug</title>
          <description>Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
          <units>percentage of study drug taken</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="97.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="95.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="95.0" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="90.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="90.0" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="95.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="60.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="90.0" upper_limit="100.0"/>
                    <measurement group_id="O3" value="100.0" lower_limit="85.0" upper_limit="100.0"/>
                    <measurement group_id="O4" value="100.0" lower_limit="100.0" upper_limit="100.0"/>
                    <measurement group_id="O5" value="100.0" lower_limit="99.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Number of Missed Doses of Study Drug</title>
        <description>Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Number of Missed Doses of Study Drug</title>
          <description>Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
          <units>missed doses</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="5"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="5"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Reason for Missed Doses of Study Drug</title>
        <description>Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48. All other instances of missing data were due to participants with no missed doses not responding to this question specifying the reason.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Reason for Missed Doses of Study Drug</title>
          <description>Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48. All other instances of missing data were due to participants with no missed doses not responding to this question specifying the reason.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Both parents were admitted in the hospital</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caregiver too sick</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caregiver was too busy to give the medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Change in daily routine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Forgot to administer medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mom was in a hurry and forgot to give child medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Tried to spit it out because of taste (away from caregiver)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No missed doses</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</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 group_id="O3" value="14"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Both parents were admitted in the hospital</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caregiver too sick</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caregiver was too busy to give the medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Change in daily routine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Forgot to administer medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mom was in a hurry and forgot to give child medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Tried to spit it out because of taste (away from caregiver)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No missed doses</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Both parents were admitted in the hospital</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caregiver too sick</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caregiver was too busy to give the medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Change in daily routine</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Forgot to administer medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mom was in a hurry and forgot to give child medication</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Tried to spit it out because of taste (away from caregiver)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No missed doses</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to</title>
        <description>Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to</title>
          <description>Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poor</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to</title>
        <description>Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
        <time_frame>Weeks 4, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to</title>
          <description>Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Usually</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Usually</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Almost always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Usually</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Ease of Giving Study Drug</title>
        <description>Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses.</description>
        <time_frame>Weeks 4, 12, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Ease of Giving Study Drug</title>
          <description>Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses.</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>The child takes by themselves easily</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The child takes easily with help</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The child takes with help but you need to threaten, bribe, or promise a reward</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>You need to hold and force the child</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>The child takes by themselves easily</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The child takes easily with help</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The child takes with help but you need to threaten, bribe, or promise a reward</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>You need to hold and force the child</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>The child takes by themselves easily</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The child takes easily with help</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The child takes with help but you need to threaten, bribe, or promise a reward</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>You need to hold and force the child</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>The child takes by themselves easily</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The child takes easily with help</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>The child takes with help but you need to threaten, bribe, or promise a reward</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>You need to hold and force the child</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Response of Child's Face When Taking Study Drug</title>
        <description>Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses.</description>
        <time_frame>Weeks 4, 12, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Response of Child's Face When Taking Study Drug</title>
          <description>Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses.</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Average</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Average</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Average</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Average</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Response of Child's Face When Taking Favorite Food</title>
        <description>Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses.</description>
        <time_frame>Weeks 4, 12, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Response of Child's Face When Taking Favorite Food</title>
          <description>Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses.</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 discontinued treatment following the Week 24 visit and was not included in analysis at Week 48.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Average</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Average</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Average</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Average</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very bad</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Time for Study Drug Tablets to Dissolve</title>
        <description>Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses</description>
        <time_frame>Weeks 4, 12, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 prematurely discontinued treatment and was not included in analysis at Week 48. Weight Band #5 dosing was not in tablet form, so this question did not apply to Weight Band #5 or to Weight Band #4 participants following dose escalation.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Time for Study Drug Tablets to Dissolve</title>
          <description>Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 prematurely discontinued treatment and was not included in analysis at Week 48. Weight Band #5 dosing was not in tablet form, so this question did not apply to Weight Band #5 or to Weight Band #4 participants following dose escalation.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than 1 minute</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 to less than 3 minutes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 to 5 minutes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than 1 minute</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 to less than 3 minutes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 to 5 minutes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than 1 minute</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 to less than 3 minutes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 to 5 minutes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than 1 minute</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 to less than 3 minutes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 to 5 minutes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve</title>
        <description>Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses</description>
        <time_frame>Weeks 4, 12, 24, and 48</time_frame>
        <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 prematurely discontinued treatment and was not included in analysis at Week 48. Weight Band #5 dosing was not in tablet form, so this question did not apply to Weight Band #5 or to Weight Band #4 participants following dose escalation.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve</title>
          <description>Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses</description>
          <population>All participants taking treatment at timepoint who received at least one dose of study treatment. One participant in Weight Band #4 prematurely discontinued treatment and was not included in analysis at Week 48. Weight Band #5 dosing was not in tablet form, so this question did not apply to Weight Band #5 or to Weight Band #4 participants following dose escalation.</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="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>It is acceptable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>It is too many</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>It is too few</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>It is acceptable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>It is too many</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>It is too few</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>It is acceptable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>It is too many</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>It is too few</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>It is acceptable</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>It is too many</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>It is too few</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antiretroviral (ARV) Resistance Mutations</title>
        <description>ARV resistance mutations at time of virologic failure and at entry for children with virologic failure.</description>
        <time_frame>Entry and confirmation of virologic failure</time_frame>
        <population>Participants experiencing confirmed virologic failure. Due to assay limitations, mutation results could not be obtained from the specimen collected at the virologic failure confirmation visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
            <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O2">
            <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
            <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O3">
            <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
            <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O4">
            <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
            <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food</description>
          </group>
          <group group_id="O5">
            <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
            <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.&#xD;
Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release): Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food</description>
          </group>
        </group_list>
        <measure>
          <title>Antiretroviral (ARV) Resistance Mutations</title>
          <description>ARV resistance mutations at time of virologic failure and at entry for children with virologic failure.</description>
          <population>Participants experiencing confirmed virologic failure. Due to assay limitations, mutation results could not be obtained from the specimen collected at the virologic failure confirmation visit.</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="1"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Entry Visit: Integrase K14R</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase A21T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase V31I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase V72I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase L74I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase T112V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase V113I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase T125A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase V126L</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase G134N</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase I135V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase K136R</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase V165I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase A196P</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase V236I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase V281M</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Integrase S283G</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease L10V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease I13V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease G16E</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease E35D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease M36I</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease R41K</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease K43R</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease H69K</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease I72V</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Protease L89M</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase E6D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase K11T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase K20R</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase V35T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase T39K</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase K43E</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase Q102K</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase K122E</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase D123S</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Entry Visit: Reverse Transcriptase C162S</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
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          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From study entry to study completion (at Week 48 or 60) or premature study discontinuation</time_frame>
      <desc>All adverse events (i.e., all grade 1 or higher) identified after enrollment were collected and entered into adverse event electronic case report forms (eCRFs). For any event involving a hypersensitivity reaction to ABC, additional data was also collected and entered into other designated eCRFs&#xD;
The definition of the term adverse event provided in Version 2.0 of the DAIDS EAE Manual was used in this study</desc>
      <group_list>
        <group group_id="E1">
          <title>Weight Band #1 (6 to Less Than 10 kg at Study Entry)</title>
          <description>Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-&lt;10 kg; as their weight increased, they received higher doses consistent with their new weight band.</description>
        </group>
        <group group_id="E2">
          <title>Weight Band #2 (10 to Less Than 14 kg at Study Entry)</title>
          <description>Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-&lt;14 kg; as their weight increased, they received higher doses consistent with their new weight band.</description>
        </group>
        <group group_id="E3">
          <title>Weight Band #3 (14 to Less Than 20 kg at Study Entry)</title>
          <description>Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-&lt;20 kg; as their weight increased, they received higher doses consistent with their new weight band.</description>
        </group>
        <group group_id="E4">
          <title>Weight Band #4 (20 to Less Than 25 kg at Study Entry)</title>
          <description>Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-&lt;25 kg; as their weight increased, they received higher doses consistent with their new weight band.</description>
        </group>
        <group group_id="E5">
          <title>Weight Band #5 (25 kg or Greater at Study Entry)</title>
          <description>Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 25.0</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="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 25.0</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="8" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Secondary thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Otorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival pallor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Hepatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tinea capitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tinea faciei</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Adverse event following immunisation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood pressure systolic increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal loss of weight</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Underweight</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Nightmare</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Childhood asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Nasal flaring</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rhonchi</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tonsillar exudate</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Tonsillar inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Perioral dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Skin plaque</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="11"/>
              </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>In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>IMPAACT Clinicaltrials.gov Coordinator</name_or_title>
      <organization>Family Health International (FHI 360)</organization>
      <phone>(919) 405-1429</phone>
      <email>IMPAACT.ctgov@fstrf.org</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/NCT03760458
org study id: IMPAACT 2019
secondary id: 38504
nct id: NCT03760458
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of
      abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living
      with HIV less than 12 years of age.
This study examined the pharmacokinetics (PK), safety, and tolerability of fixed-dose
      combination abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) dispersible and immediate
      release tablets in children living with HIV less than 12 years of age.

      Children were enrolled into one of five ABC/DTG/3TC dosing groups based on their weight. The
      first 5-7 children within each weight-band underwent intensive PK assessments 5-10 days after
      starting ABC/DTG/3TC to confirm dose selection. Children remained on their initial dose of
      ABC/DTG/3TC through Week 4. After Week 4, ABC/DTG/3TC dosing was adjusted based on PK results
      at the individual or weight-band level, and/or an individual child's growth and weight gain
      over time.

      Follow-up study visits for all participants occurred at Weeks 1, 4, 12, 24, 36, and 48. If
      participants had a known M184 resistance mutation, they had additional study visits at Weeks
      8, 16, and 20. Study visits included physical examination, study drug adherence and
      tolerability questionnaires, blood collection, and intensive PK sampling. Following the Week
      48 study visit, some children were allowed to continue follow-up through up to 144 weeks if
      alternative post-study drug supply was not yet available.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Geometric Mean Area Under the Plasma Concentration-time Curve Over 24 Hours (AUC0-24h) for ABC, DTG, and 3TC
time frame: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
description: Based on analysis of intensive pharmacokinetic (PK) samples. The geometric mean AUC0-24h for each Weight Band was compared to the lower and upper reference values (in ug*h/mL) for DTG (35.1, 134), ABC (6.3, 50.4), and 3TC (6.3, 26.5). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.
measure: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
time frame: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
description: Based on analysis of intensive PK samples. Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.
measure: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
time frame: Week 1; Blood samples were drawn at pre-dose and 1, 2, 3, 4, 6, 8, and 24 hours post dosing.
description: Based on analysis of intensive PK samples. The geometric mean C24h for each Weight Band was compared to the lower and upper reference values (in ug/mL) for DTG (0.67, 2.97). Steady state was measured at Week 1, but was re-collected later for two participants due to a specimen handling error for the Week 1 specimens.
measure: Percentage of Participants Who Had at Least One Adverse Event Through Week 24
time frame: Measured from treatment initiation through Week 24
description: Adverse event (AE) grading was based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1, dated July 2017. AEs of any grade were reported.
measure: Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 24
time frame: Measured from treatment initiation through Week 24
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 24
time frame: Measured from treatment initiation through Week 24
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 24
time frame: Measured from treatment initiation through Week 24
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
measure: Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 24
time frame: Measured from treatment initiation through Week 24
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.
measure: Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 24
time frame: Measured from treatment initiation through Week 24
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Population PK: Geometric Mean AUC0-24h for ABC, DTG, and 3TC
time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
description: Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
measure: Population PK: Geometric Mean Concentration at Time 0 (Pre-dose) (C0h) for ABC, DTG, and 3TC
time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
description: Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
measure: Population PK: Geometric Mean Concentration at 24 Hours Post-dose (C24h) for ABC, DTG, and 3TC
time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
description: Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
measure: Population PK: Geometric Mean Maximum Plasma Concentration (Cmax) for ABC, DTG, and 3TC
time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
description: Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
measure: Population PK: Geometric Mean Time to Maximum Concentration (Tmax) for ABC, DTG, and 3TC
time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
description: Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
measure: Population PK: Geometric Mean Apparent Oral Clearance (CL/F) for ABC, DTG, and 3TC
time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
description: Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
measure: Population PK: Geometric Mean Half-life (t1/2) for ABC, DTG, and 3TC
time frame: Measured from Week 1 through Week 48 over 24 hours post-dose
description: Population PK: Geometric Mean Area Under the Plasma Concentration-time Curve for ABC, DTG, and 3TC derived from population PK model. Population apparent oral clearance and apparent volume of distribution were determined with non-linear mixed effects modeling. DTG and 3TC were fit to a 1-compartment model and ABC was fit to 2-compartment model. Weight was a covariate on clearance and volume for all drugs and enzyme maturation as a covariate on apparent oral clearance for DTG. The posthoc parameter of AUC0-24 was estimated using non-compartmental analysis of simulated steady-state concentration-time profiles and stratified by weight band.
measure: Percentage of Participants With at Least One Adverse Event Through Week 48
time frame: Measured from treatment initiation through Week 48
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.
measure: Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 48
time frame: Measured from treatment initiation through Week 48
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 48
time frame: Measured from treatment initiation through Week 48
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 48
time frame: Measured from treatment initiation through Week 48
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.
measure: Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 48
time frame: Measured from treatment initiation through Week 48
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.
measure: Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 48
time frame: Measured from treatment initiation through Week 48
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Percentage of Participants Who Had at Least One Adverse Event Through Week 60
time frame: Measured from treatment initiation through Week 60
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported.
measure: Percentage of Participants Who Had at Least One Grade 3 or Grade 4 Adverse Event Assessed as Related to Study Drug Through Week 60
time frame: Measured from treatment initiation through Week 60
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Percentage of Participants Who Had a Grade 5 Adverse Event Assessed as Related to Study Drug Through Week 60
time frame: Measured from treatment initiation through Week 60
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Percentage of Participants Who Had at Least One Life-threatening Adverse Event Assessed as Related to Study Drug Through Week 60
time frame: Measured from treatment initiation through Week 60
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Life-threatening was defined according to Version 2.0 of the DAIDS EAE Manual.
measure: Percentage of Participants Who Had at Least One Serious Adverse Event Assessed as Related to Study Drug Through Week 60
time frame: Measured from treatment initiation through Week 60
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator. Seriousness was defined according to Version 2.0 of the DAIDS EAE Manual.
measure: Percentage of Participants Who Had at Least One Adverse Event Assessed as Related to Study Drug That Led to Permanent Discontinuation of Study Drug Through Week 60
time frame: Measured from treatment initiation through Week 60
description: AE grading was based on DAIDS AE Grading Table, Corrected Version 2.1, dated July 2017. AEs of any grade were reported. The relationship to study drug was assessed by the site investigator.
measure: Percentage of Participants Who Experienced Virologic Failure Through Week 48
time frame: Measured from treatment initiation through Week 48
description: Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.
measure: Percentage of Participants Who Experienced Virologic Failure Through Week 60
time frame: Measured from treatment initiation through Week 60
description: Percentage of participants who experienced virologic failure based on the following definition: ART-experienced participants who had two subsequent viral loads greater or equal to 200 copies/mL at any time, or for ART-naive participants, two subsequent viral loads greater to or equal to 200 copies/mL at 24 weeks or after. The results are presented by ART experienced, ART naïve, and overall.
measure: Percentage of Participants With HIV-1 RNA Less Than 200 Copies/mL
time frame: Weeks 4, 24, and 48
description: Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.
measure: Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 200 Copies/mL Using FDA Snapshot Algorithm
time frame: Weeks 4, 24, and 48
description: Percentage of participants with virologic success of HIV-1 RNA less than 200 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.
measure: Percentage of Participants With Virologic Success of HIV-1 RNA Less Than 50 Copies/mL Using FDA Snapshot Algorithm
time frame: Weeks 4, 24, and 48
description: Percentage of participants with virologic success of HIV-1 RNA less than 50 copies/mL using FDA snapshot algorithm at Weeks 4, 24, and 48. Viral loads less than the lower limit of quantification were imputed as one less than the lower limit.
measure: Median (Q1, Q3) CD4+ Cell Count
time frame: Weeks 4, 24, and 48
description: Per protocol, CD4 + cell counts were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.
measure: Median (Q1, Q3) CD4+ Percentage
time frame: Weeks 4, 24, and 48
description: Per protocol, CD4+ cell count percentages were not required at Week 60. CD4 results were therefore analyzed through Week 48. For participants who discontinued study drug prior to the other timepoints due to safety or virologic failure, results imputed using the baseline value.
measure: Median (Q1,Q3) Change From Baseline in Total Cholesterol
time frame: Baseline, Weeks 24 and 48
description: Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.
measure: Median (Q1,Q3) Change From Baseline in HDL
time frame: Baseline, Weeks 24 and 48
description: Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.
measure: Median (Q1,Q3) Change From Baseline in LDL
time frame: Baseline, Weeks 24 and 48
description: Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.
measure: Median (Q1,Q3) Change From Baseline in Triglycerides
time frame: Baseline, Weeks 24 and 48
description: Baseline is defined as the latest pre-dose assessment with a non-missing value. Where time was not collected, assessments on the day of treatment initiation are assumed to be taken prior to first dose. Missing results for participants who discontinued study treatment prior to the specified timepoint due to safety or virologic failure were imputed using the baseline value. Per protocol, there was no expectation of evaluating lipids in a fasting state for this study. A relative few participants were identified as having been in a fasted state at a given study visit, but the majority did not fast for this evaluation.
measure: Parent/Guardian-reported Percent Adherence to Study Drug
time frame: Weeks 4, 24, and 48
description: Parent/guardian-reported percent adherence to study drug in the 30 days prior to the study visit according to adherence questionnaire responses.
measure: Parent/Guardian-reported Number of Missed Doses of Study Drug
time frame: Weeks 4, 24, and 48
description: Parent/guardian-reported number of missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.
measure: Parent/Guardian-reported Reason for Missed Doses of Study Drug
time frame: Weeks 4, 24, and 48
description: Parent/guardian-reported reason for missed doses of study drug in the 30 days prior to the study visit according to adherence questionnaire responses.
measure: Parent/Guardian-reported Response of How Well the Person Usually Responsible Administered the Study Drug in the Way They Were Supposed to
time frame: Weeks 4, 24, and 48
description: Parent/guardian-reported response of how well the person usually responsible administered the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.
measure: Parent/Guardian-reported Response of How Often the Child Received the Study Drug in the Way They Were Supposed to
time frame: Weeks 4, 24, and 48
description: Parent/guardian-reported response of how often the child received the study drug in the way they were supposed to in the 30 days prior to the study visit according to adherence questionnaire responses.
measure: Parent/Guardian-reported Ease of Giving Study Drug
time frame: Weeks 4, 12, 24, and 48
description: Parent/guardian-reported ease of giving study drug according to palatability questionnaire responses.
measure: Parent/Guardian-reported Response of Child's Face When Taking Study Drug
time frame: Weeks 4, 12, 24, and 48
description: Parent/guardian-reported response of child's face when taking study drug according to palatability questionnaire responses.
measure: Parent/Guardian-reported Response of Child's Face When Taking Favorite Food
time frame: Weeks 4, 12, 24, and 48
description: Parent/guardian-reported response of child's face when taking favorite food according to palatability questionnaire responses.
measure: Parent/Guardian-reported Time for Study Drug Tablets to Dissolve
time frame: Weeks 4, 12, 24, and 48
description: Parent/guardian-reported time for study drug tablets to dissolve according to acceptability questionnaire responses
measure: Parent/Guardian-reported Satisfaction With the Number of Study Drug Tablets to Dissolve
time frame: Weeks 4, 12, 24, and 48
description: Parent/guardian-reported satisfaction with the number of study drug tablets to dissolve according to acceptability questionnaire responses
measure: Antiretroviral (ARV) Resistance Mutations
time frame: Entry and confirmation of virologic failure
description: ARV resistance mutations at time of virologic failure and at entry for children with virologic failure.
arm group label: Weight Band #1 (6 to less than 10 kg at study entry)
arm group type: Experimental
description: Children weighing 6 to less than 10 kg at study entry. These children received 3 dispersible tablets of ABC/DTG/3TC daily while weighing 6-<10 kg; as their weight increased, they received higher doses consistent with their new weight band.
arm group label: Weight Band #2 (10 to less than 14 kg at study entry)
arm group type: Experimental
description: Children weighing 10 to less than 14 kg at study entry. These children received 4 dispersible tablets of ABC/DTG/3TC daily while weighing 10-<14 kg; as their weight increased, they received higher doses consistent with their new weight band.
arm group label: Weight Band #3 (14 to less than 20 kg at study entry)
arm group type: Experimental
description: Children weighing 14 to less than 20 kg at study entry. These children received 5 dispersible tablets of ABC/DTG/3TC daily while weighing 14-<20 kg; as their weight increased, they received higher doses consistent with their new weight band.
arm group label: Weight Band #4 (20 to less than 25 kg at study entry)
arm group type: Experimental
description: Children weighing 20 to less than 25 kg at study entry. These children received 6 dispersible tablets of ABC/DTG/3TC daily while weighing 20-<25 kg; as their weight increased, they received higher doses consistent with their new weight band.
arm group label: Weight Band #5 (25 kg or greater at study entry)
arm group type: Experimental
description: Children weighing 25 kg or greater at study entry. These children received 1 immediate release tablet of ABC/DTG/3TC daily.
intervention type: Drug
intervention name: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets
description: Fixed-dose combination dispersible tablets containing 60 mg ABC, 5 mg DTG, and 30 mg 3TC; administered orally once daily with or without food
arm group label: Weight Band #1 (6 to less than 10 kg at study entry)
arm group label: Weight Band #2 (10 to less than 14 kg at study entry)
arm group label: Weight Band #3 (14 to less than 20 kg at study entry)
arm group label: Weight Band #4 (20 to less than 25 kg at study entry)
intervention type: Drug
intervention name: Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)
description: Fixed-dose combination immediate release tablets containing 600 mg ABC, 50 mg DTG, and 300 mg 3TC; administered orally once daily with or without food
arm group label: Weight Band #5 (25 kg or greater at study entry)
other name: Triumeq
criteria: 
gender: All
minimum age: N/A
maximum age: 11 Years
healthy volunteers: No
last name: Patricia Flynn, MD
role: Study Chair
affiliation: St. Jude Children's Research Hospital
last name: Helena Rabie, MBChB, MMED, FCPaed
role: Study Chair
affiliation: University of Stellenbosch
last name: Jennifer Kiser, PharmD, PhD
role: Study Chair
affiliation: University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences
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country: Botswana
country: South Africa
country: Thailand
country: United States
url: https://rsc.niaid.nih.gov/clinical-research-sites/daids-adverse-event-grading-tables
description: The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Corrected Version 2.1 (July 2017)
url: http://rsc.niaid.nih.gov/clinical-research-sites/manual-expedited-reporting-adverse-events-daids
description: Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
url: https://www.fda.gov/files/drugs/published/Human-Immunodeficiency-Virus-1-Infection--Developing-Antiretroviral-Drugs-for-Treatment.pdf
description: FDA Snapshot Algorithm
responsible party type: Sponsor
mesh term: HIV Infections
mesh term: Lamivudine
mesh term: Abacavir
mesh term: Dideoxynucleosides
mesh term: Dolutegravir
sharing ipd: Yes
ipd description: Individual participant data that underlie results in the publication, after deidentification.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 3 months following publication and available throughout period of funding of the International Maternal Pediatric Adolescent AIDS Clinical Trial (IMPAACT) Network by NIH.
ipd access criteria: With whom?
Researchers who provide a methodologically sound proposal for use of the data that is approved by the IMPAACT Network.
For what types of analyses?
To achieve aims in the proposal approved by the IMPAACT Network.
By what mechanism will data be made available?
Researchers may submit a request for access to data using the IMPAACT "Data Request" form at: https://www.impaactnetwork.org/studies/submit-research-proposal. Researchers of approved proposals will need to sign an IMPAACT Data Use Agreement before receiving the data.
provided document: 
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reported events: 
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point of contact: 