<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/NCT02979613</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-320-4018</org_study_id>
    <secondary_id>2016-003632-20</secondary_id>
    <nct_id>NCT02979613</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed</brief_title>
  <official_title>A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching From Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 mg QD in Subjects With Chronic Hepatitis B Who Are Virologically Suppressed</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</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 primary objectives of this study are to evaluate the efficacy, safety, and tolerability&#xD;
      of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate&#xD;
      (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm</measure>
    <time_frame>Week 48</time_frame>
    <description>The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:&#xD;
Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or&#xD;
Did not have on-treatment HBV DNA data available in the Week 48 analysis window and&#xD;
Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or&#xD;
Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm</measure>
    <time_frame>Week 96</time_frame>
    <description>The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:&#xD;
Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or&#xD;
Did not have on-treatment HBV DNA data available in the Week 96 analysis window and&#xD;
Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or&#xD;
Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL at Week 48</measure>
    <time_frame>Weeks 48</time_frame>
    <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL (Target Detected/Not Detected) at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels &lt;20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL at Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL (Target Detected/Not Detected) at Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels &lt;20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBeAg Seroconversion at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBeAg Loss at Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBeAg Seroconversion at Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBsAg Seroconversion at Week 48</measure>
    <time_frame>Week 48</time_frame>
    <description>HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBsAg Loss at Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBsAg Seroconversion at Week 96</measure>
    <time_frame>Week 96</time_frame>
    <description>HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)</measure>
    <time_frame>Week 48</time_frame>
    <description>Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)</measure>
    <time_frame>Week 48</time_frame>
    <description>ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)</measure>
    <time_frame>Week 96</time_frame>
    <description>Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)</measure>
    <time_frame>Week 96</time_frame>
    <description>ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FibroTest® Score at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FibroTest® Score at Week 96</measure>
    <time_frame>Baseline; Week 96</time_frame>
    <description>The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Hip BMD at Week 96</measure>
    <time_frame>Baseline; Week 96</time_frame>
    <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Spine BMD at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Spine BMD at Week 96</measure>
    <time_frame>Baseline; Week 96</time_frame>
    <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48</measure>
    <time_frame>Baseline; Week 48</time_frame>
    <description>Cockcroft-Gault formula is as follows:&#xD;
For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)&#xD;
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).&#xD;
Change from baseline was calculated as the value at Week 48 minus the value at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in eGFR-CG at Week 96</measure>
    <time_frame>Baseline; Week 96</time_frame>
    <description>Cockcroft-Gault formula is as follows:&#xD;
For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)&#xD;
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).&#xD;
Change from baseline was calculated as the value at Week 96 minus the value at Baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">490</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>TAF 25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Double-blind (DB) phase: TAF 25 mg + TDF placebo for up to 53 weeks. Open-label extension (OLE) phase: TAF 25 mg for up to 52 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TDF 300 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>DB phase: TDF 300 mg + TAF placebo for up to 50 weeks. OLE phase: TAF 25 mg for up to 52 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAF</intervention_name>
    <description>25 mg tablet administered orally once daily</description>
    <arm_group_label>TAF 25 mg</arm_group_label>
    <arm_group_label>TDF 300 mg</arm_group_label>
    <other_name>Vemlidy®</other_name>
    <other_name>GS-7340</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TDF</intervention_name>
    <description>300 mg tablet administered orally once daily</description>
    <arm_group_label>TDF 300 mg</arm_group_label>
    <other_name>Viread®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAF Placebo</intervention_name>
    <description>Tablet administered orally once daily</description>
    <arm_group_label>TDF 300 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TDF Placebo</intervention_name>
    <description>Tablet administered orally once daily</description>
    <arm_group_label>TAF 25 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Must have the ability to understand and sign a written informed consent form; consent&#xD;
             must be obtained prior to initiation of study procedures&#xD;
&#xD;
          -  Adult male and non-pregnant, non-lactating females&#xD;
&#xD;
          -  Documented evidence of chronic hepatitis B virus (HBV) infection previously&#xD;
&#xD;
          -  Maintained on tenofovir disoproxil fumarate (TDF) 300 mg once daily for at least 48&#xD;
             weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viral&#xD;
             suppression (HBV DNA &lt; lower limit of quantitation) for a minimum of 12 weeks prior to&#xD;
             screening&#xD;
&#xD;
          -  Adequate renal function&#xD;
&#xD;
          -  Normal Electrocardiogram&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women or women who are breastfeeding&#xD;
&#xD;
          -  Males and females of reproductive potential who are unwilling to use an &quot;effective&quot;,&#xD;
             protocol-specified method(s) of contraception during the study.&#xD;
&#xD;
          -  Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or human&#xD;
             immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Evidence of hepatocellular carcinoma&#xD;
&#xD;
          -  Current evidence of, or recent (≤ 5 year) history of clinical hepatic decompensation&#xD;
&#xD;
          -  Abnormal hematological and biochemical parameters, including:&#xD;
&#xD;
               -  Hemoglobin &lt; 10 g/dL&#xD;
&#xD;
               -  Absolute neutrophil count &lt; 750/mm^3&#xD;
&#xD;
               -  Platelets ≤ 50,000/mm^3&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) &gt; 5 × upper&#xD;
                  limit of the normal (ULN)&#xD;
&#xD;
               -  Albumin &lt; 3.0 mg/ dL&#xD;
&#xD;
               -  International normalized ratio (INR) &gt; 1.5 × ULN (unless stable on anticoagulant&#xD;
                  regimen)&#xD;
&#xD;
               -  Total bilirubin &gt; 2.5 × ULN&#xD;
&#xD;
          -  Received solid organ or bone marrow transplant&#xD;
&#xD;
          -  Malignancy within 5 years prior to screening, with the exception of specific cancers&#xD;
             that are cured by surgical resection (eg, basal cell skin cancer). Individuals under&#xD;
             evaluation for possible malignancy are not eligible.&#xD;
&#xD;
          -  Currently receiving therapy with immunomodulators (eg, corticosteroids), nephrotoxic&#xD;
             agents, or agents capable of modifying renal excretion&#xD;
&#xD;
          -  Individuals receiving ongoing therapy with drugs not to be used with TAF or TDF or&#xD;
             individuals with a known hypersensitivity to study drugs, metabolites, or formulation&#xD;
             excipients&#xD;
&#xD;
          -  Current alcohol or substance abuse judged by the investigator to potentially interfere&#xD;
             with compliance&#xD;
&#xD;
          -  Any other clinical condition or prior therapy that, in the opinion of the&#xD;
             investigator, would make the individual unsuitable for the study or unable to comply&#xD;
             with dosing requirements.&#xD;
&#xD;
          -  Use of investigational agents within 3 months of screening, unless allowed by the&#xD;
             sponsor&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>11355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edmonton</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi-d</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daegu</city>
        <zip>700-721</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>03830</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>06973</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <zip>152-703</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Majadahonda</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chiayi City</city>
        <zip>60002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei City</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Lampertico P, Buti M, Fung S, Ahn SH, Chuang WL, Tak WY, Ramji A, Chen CY, Tam E, Bae H, Ma X, Flaherty JF, Gaggar A, Lau A, Liu Y, Wu G, Suri V, Tan SK, Subramanian GM, Trinh H, Yoon SK, Agarwal K, Lim YS, Chan HLY. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020 May;5(5):441-453. doi: 10.1016/S2468-1253(19)30421-2. Epub 2020 Feb 20.</citation>
    <PMID>32087795</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>August 30, 2019</results_first_submitted>
  <results_first_submitted_qc>August 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2019</results_first_posted>
  <last_update_submitted>August 24, 2020</last_update_submitted>
  <last_update_submitted_qc>August 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</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>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>18 months after study completion</ipd_time_frame>
    <ipd_access_criteria>A secured external environment with username, password, and RSA code.</ipd_access_criteria>
    <ipd_url>https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Original</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>September 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02979613/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Amendment 1</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>December 21, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02979613/Prot_001.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>March 11, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT02979613/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 29 December 2016. The last study visit occurred on 30 January 2020.</recruitment_details>
      <pre_assignment_details>541 participants were screened.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TAF 25 mg</title>
          <description>Participants who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF) 300 mg tablet orally once daily received tenofovir alafenamide (TAF) 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the double-blind (DB) phase. Participants who completed DB treatment and were willing to enter in the open-label extension (OLE) phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
        </group>
        <group group_id="P2">
          <title>TDF 300 mg</title>
          <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-Blind Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="245"/>
                <participants group_id="P2" count="245"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="235"/>
                <participants group_id="P2" count="237"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-Label Extension (OLE) Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="235"/>
                <participants group_id="P2" count="237"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="232"/>
                <participants group_id="P2" count="231"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator's Discretion</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>TAF 25 mg</title>
          <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
        </group>
        <group group_id="B2">
          <title>TDF 300 mg</title>
          <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="243"/>
            <count group_id="B2" value="245"/>
            <count group_id="B3" value="488"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51" spread="10.5"/>
                    <measurement group_id="B2" value="51" spread="10.8"/>
                    <measurement group_id="B3" value="51" spread="10.7"/>
                  </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; 50 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="109"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 50 Years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="136"/>
                    <measurement group_id="B2" value="136"/>
                    <measurement group_id="B3" value="272"/>
                  </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="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="179"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="345"/>
                  </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="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="240"/>
                    <measurement group_id="B2" value="245"/>
                    <measurement group_id="B3" value="485"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="195"/>
                    <measurement group_id="B2" value="205"/>
                    <measurement group_id="B3" value="400"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South Korea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hong Kong</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </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="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alanine Aminotransferase (ALT)</title>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28" spread="15.6"/>
                    <measurement group_id="B2" value="26" spread="12.0"/>
                    <measurement group_id="B3" value="27" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ALT Level Based on Central Lab Normal Range</title>
          <description>Central laboratory upper limit of normal (ULN) for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years.</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="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>≤ ULN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="211"/>
                    <measurement group_id="B2" value="226"/>
                    <measurement group_id="B3" value="437"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; ULN to 5xULN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 5xULN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ALT Level Based on 2018 American Association for the Study of Liver Diseases (AASLD) Normal Range</title>
          <description>The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males.</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="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>≤ ULN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="191"/>
                    <measurement group_id="B2" value="192"/>
                    <measurement group_id="B3" value="383"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; ULN to 5xULN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="105"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt; 5xULN</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatitis B virus (HBV) DNA Category</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="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt; 20 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="242"/>
                    <measurement group_id="B3" value="480"/>
                  </measurement_list>
                </category>
                <category>
                  <title>20 to &lt; 69 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥ 69 IU/mL</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatitis B e Antigen/Antibody (HBeAg/HBeAb) Status</title>
          <description>HBeAb status was imputed as negative if missing.</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="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Positive/Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive/Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Negative/Negative</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Negative/Positive</title>
                  <measurement_list>
                    <measurement group_id="B1" value="148"/>
                    <measurement group_id="B2" value="138"/>
                    <measurement group_id="B3" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FibroTest® Score</title>
          <description>The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis.</description>
          <population>Participants in Safety Analysis Set with available data were analyzed.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="241"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="486"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.42" spread="0.234"/>
                    <measurement group_id="B2" value="0.41" spread="0.211"/>
                    <measurement group_id="B3" value="0.42" spread="0.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)</title>
          <units>mL/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95.0" spread="25.58"/>
                    <measurement group_id="B2" value="93.8" spread="25.16"/>
                    <measurement group_id="B3" value="94.4" spread="25.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hip Bone Mineral Density (BMD) Status</title>
          <population>Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline hip BMD values.</population>
          <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="241"/>
                    <count group_id="B2" value="244"/>
                    <count group_id="B3" value="485"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal (T-score ≥ -1.0)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="143"/>
                    <measurement group_id="B2" value="124"/>
                    <measurement group_id="B3" value="267"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Osteopenia (-2.5 ≤ T-score &lt; -1.0)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="116"/>
                    <measurement group_id="B3" value="205"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Osteoporosis (T-score &lt; -2.5)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Spine BMD Status</title>
          <description>Spine DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values.</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="243"/>
                    <count group_id="B2" value="245"/>
                    <count group_id="B3" value="488"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Normal (T-score ≥ -1.0)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Osteopenia (-2.5 ≤ T-score &lt; -1.0)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="187"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Osteoporosis (T-score &lt; -2.5)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm</title>
        <description>The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:&#xD;
Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or&#xD;
Did not have on-treatment HBV DNA data available in the Week 48 analysis window and&#xD;
Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or&#xD;
Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL</description>
        <time_frame>Week 48</time_frame>
        <population>The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm</title>
          <description>The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:&#xD;
Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or&#xD;
Did not have on-treatment HBV DNA data available in the Week 48 analysis window and&#xD;
Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or&#xD;
Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL</description>
          <population>The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The null hypothesis was that the TAF group is at least 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48. The alternative hypothesis was that the TAF group is less than 4% worse than the TDF group with respect to the percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.</non_inferiority_desc>
            <param_type>Difference in the Percentages</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted Mantel-Haenszel (MH) percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm</title>
        <description>The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:&#xD;
Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or&#xD;
Did not have on-treatment HBV DNA data available in the Week 96 analysis window and&#xD;
Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or&#xD;
Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm</title>
          <description>The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:&#xD;
Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or&#xD;
Did not have on-treatment HBV DNA data available in the Week 96 analysis window and&#xD;
Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or&#xD;
Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL</description>
          <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4"/>
                    <measurement group_id="O2" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.</non_inferiority_desc>
            <param_type>Difference in the Percentages</param_type>
            <param_value>0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9953</p_value>
            <p_value_desc>P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL at Week 48</title>
        <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis.</description>
        <time_frame>Weeks 48</time_frame>
        <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL at Week 48</title>
          <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis.</description>
          <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.3"/>
                    <measurement group_id="O2" value="96.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was assessed using a 95% CI approach, with a non-inferiority margin of 4%.</non_inferiority_desc>
            <param_type>Difference in the Percentages</param_type>
            <param_value>-0.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>3.7</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.98</p_value>
            <p_value_desc>P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL (Target Detected/Not Detected) at Week 48</title>
        <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels &lt;20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches.</description>
        <time_frame>Week 48</time_frame>
        <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL (Target Detected/Not Detected) at Week 48</title>
          <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels &lt;20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches.</description>
          <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>M = F Approach: &lt; 20 IU/mL Target Not Detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.4"/>
                    <measurement group_id="O2" value="62.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M = F Approach: &lt; 20 IU/mL Target Detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9"/>
                    <measurement group_id="O2" value="34.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M = E Approach: &lt; 20 IU/mL Target Not Detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.5"/>
                    <measurement group_id="O2" value="64.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M = E Approach: &lt; 20 IU/mL Target Detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0"/>
                    <measurement group_id="O2" value="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL at Week 96</title>
        <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL at Week 96</title>
          <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis.</description>
          <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7"/>
                    <measurement group_id="O2" value="93.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority was assessed using a 95% confidence interval (CI) approach, with a non-inferiority margin of 4%.</non_inferiority_desc>
            <param_type>Difference in the Percentages</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95.0</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.5</ci_lower_limit>
            <ci_upper_limit>5.2</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6863</p_value>
            <p_value_desc>P-value for the superiority tests compared the percentage of each HBV DNA outcome was from CMH tests stratified by baseline age groups and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL (Target Detected/Not Detected) at Week 96</title>
        <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels &lt;20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBV DNA Levels &lt; 20 IU/mL (Target Detected/Not Detected) at Week 96</title>
          <description>The percentage of participants with HBV DNA &lt; 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels &lt;20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches.</description>
          <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>M = F Approach: &lt; 20 IU/mL Target Not Detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.8"/>
                    <measurement group_id="O2" value="66.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M = F Approach: &lt; 20 IU/mL Target Detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.8"/>
                    <measurement group_id="O2" value="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M = E Approach: &lt; 20 IU/mL Target Not Detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.3"/>
                    <measurement group_id="O2" value="70.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>M = E Approach: &lt; 20 IU/mL Target Detected</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3"/>
                    <measurement group_id="O2" value="29.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48</title>
        <description>HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.</description>
        <time_frame>Week 48</time_frame>
        <population>The Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBeAg-positive and HBeAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48</title>
          <description>HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.</description>
          <population>The Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBeAg-positive and HBeAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.</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="78"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7"/>
                    <measurement group_id="O2" value="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7258</p_value>
            <p_value_desc>P-value was from the CMH test, stratified by baseline age groups (&lt; 50, ≥ 50 years).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.2</ci_lower_limit>
            <ci_upper_limit>10.1</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBeAg Seroconversion at Week 48</title>
        <description>HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
        <time_frame>Week 48</time_frame>
        <population>Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBeAg Seroconversion at Week 48</title>
          <description>HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
          <population>Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="78"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1348</p_value>
            <p_value_desc>P-value was from the CMH test, stratified by baseline age groups (&lt; 50, ≥ 50 years).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.3</ci_lower_limit>
            <ci_upper_limit>7.7</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBeAg Loss at Week 96</title>
        <description>HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBeAg Loss at Week 96</title>
          <description>HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.</description>
          <population>Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="78"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.9"/>
                    <measurement group_id="O2" value="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1005</p_value>
            <p_value_desc>P-value was from CMH tests stratified by baseline age groups (&lt; 50, ≥ 50 years).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>9.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.0</ci_lower_limit>
            <ci_upper_limit>20.1</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBeAg Seroconversion at Week 96</title>
        <description>HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBeAg Seroconversion at Week 96</title>
          <description>HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
          <population>Participants in the Serologically Evaluable Full Analysis Set for HBeAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="78"/>
                <count group_id="O2" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4154</p_value>
            <p_value_desc>P-value was from CMH tests stratified by baseline age groups (&lt; 50, ≥ 50 years).</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.5</ci_lower_limit>
            <ci_upper_limit>9.5</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48</title>
        <description>HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.</description>
        <time_frame>Week 48</time_frame>
        <population>The Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBsAg-positive and HBsAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48</title>
          <description>HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.</description>
          <population>The Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion included all participants who were randomized and received at least 1 dose of study drug and were HBsAg-positive and HBsAb-negative or had a missing value at baseline. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0281</p_value>
            <p_value_desc>P-value was from the CMH test, stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>-2.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBsAg Seroconversion at Week 48</title>
        <description>HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
        <time_frame>Week 48</time_frame>
        <population>Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBsAg Seroconversion at Week 48</title>
          <description>HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
          <population>Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBsAg Loss at Week 96</title>
        <description>HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBsAg Loss at Week 96</title>
          <description>HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.</description>
          <population>Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6"/>
                    <measurement group_id="O2" value="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5373</p_value>
            <p_value_desc>P-value was from CMH tests stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBsAg Seroconversion at Week 96</title>
        <description>HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBsAg Seroconversion at Week 96</title>
          <description>HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.</description>
          <population>Participants in the Serologically Evaluable Full Analysis Set for HBsAg loss and seroconversion were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                    <measurement group_id="O2" value="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5845</p_value>
            <p_value_desc>P-value was from CMH tests stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.7</ci_lower_limit>
            <ci_upper_limit>2.5</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)</title>
        <description>Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
        <time_frame>Week 48</time_frame>
        <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)</title>
          <description>Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
          <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Laboratory Criteria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3"/>
                    <measurement group_id="O2" value="84.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AASLD Criteria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.0"/>
                    <measurement group_id="O2" value="75.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Central Laboratory Criteria</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1405</p_value>
            <p_value_desc>P-value was from the CMH test, stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>4.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>10.6</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AASLD Criteria</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3133</p_value>
            <p_value_desc>P-value was from the CMH test, stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>11.4</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)</title>
        <description>ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
        <time_frame>Week 48</time_frame>
        <population>Participants in the Full Analysis Set with Baseline ALT &gt; ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)</title>
          <description>ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
          <population>Participants in the Full Analysis Set with Baseline ALT &gt; ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Laboratory Criteria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="36.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AASLD Criteria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Central Laboratory criteria</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3381</p_value>
            <p_value_desc>P-value was from the CMH test, stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>14.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.4</ci_lower_limit>
            <ci_upper_limit>44.6</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AASLD Criteria</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0136</p_value>
            <p_value_desc>P-value was from the CMH test, stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>23.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.3</ci_lower_limit>
            <ci_upper_limit>42.3</ci_upper_limit>
            <estimate_desc>Difference in the percentage of participants between the treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)</title>
        <description>Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)</title>
          <description>Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
          <population>Participants in the Full Analysis Set were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="243"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Laboratory Criteria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.5"/>
                    <measurement group_id="O2" value="91.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AASLD Criteria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.7"/>
                    <measurement group_id="O2" value="86.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Central Laboratory Criteria</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2803</p_value>
            <p_value_desc>P-value was from CMH tests stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>-2.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.4</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AASLD Criteria</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0788</p_value>
            <p_value_desc>P-value was from CMH tests stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>-5.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.6</ci_lower_limit>
            <ci_upper_limit>0.7</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)</title>
        <description>ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
        <time_frame>Week 96</time_frame>
        <population>Participants in the Full Analysis Set with Baseline ALT &gt; ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)</title>
          <description>ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to &lt; 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to &lt; 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.</description>
          <population>Participants in the Full Analysis Set with Baseline ALT &gt; ULN were analyzed. Participants were analyzed according to the treatment to which they were randomized.</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="52"/>
                <count group_id="O2" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Central Laboratory Criteria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.3"/>
                    <measurement group_id="O2" value="78.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AASLD Criteria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="52"/>
                    <count group_id="O2" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.8"/>
                    <measurement group_id="O2" value="73.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Central Laboratory Criteria</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0880</p_value>
            <p_value_desc>P-value was from CMH tests stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>-23.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.2</ci_lower_limit>
            <ci_upper_limit>3.4</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AASLD Criteria</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0510</p_value>
            <p_value_desc>P-value was from CMH tests stratified by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Difference in the Percentages</param_type>
            <param_value>-18.6</param_value>
            <ci_percent>95.0</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.4</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
            <estimate_desc>Difference in the percentages of participants between treatment groups and its 95% CI were calculated based on the stratum-adjusted MH percentage, adjusted by baseline age groups (&lt; 50, ≥ 50 years) and baseline HBeAg status strata.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FibroTest® Score at Week 48</title>
        <description>The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FibroTest® Score at Week 48</title>
          <description>The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="234"/>
                <count group_id="O2" value="236"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.082"/>
                    <measurement group_id="O2" value="-0.01" spread="0.082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value, difference in least squares mean (LSM), and its 95% CI were derived from analysis of variance (ANOVA) model with baseline age groups (&lt; 50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0186</p_value>
            <method>ANOVA</method>
            <param_type>Difference in LSM</param_type>
            <param_value>-0.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.03</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FibroTest® Score at Week 96</title>
        <description>The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.</description>
        <time_frame>Baseline; Week 96</time_frame>
        <population>Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FibroTest® Score at Week 96</title>
          <description>The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.</description>
          <population>Participants in the Full Analysis Set with available data were analyzed. Participants were analyzed according to the treatment to which they were randomized.</population>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
                <count group_id="O2" value="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.080"/>
                    <measurement group_id="O2" value="-0.03" spread="0.090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (&lt;50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6956</p_value>
            <method>ANOVA</method>
            <param_type>Difference in LSM</param_type>
            <param_value>0.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.02</ci_lower_limit>
            <ci_upper_limit>0.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48</title>
        <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Participants in the Hip DXA Analysis Set (included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing baseline hip BMD values) with available data were analysed. Participants were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48</title>
          <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
          <population>Participants in the Hip DXA Analysis Set (included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing baseline hip BMD values) with available data were analysed. Participants were analyzed according to the treatment they actually received.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="225"/>
                <count group_id="O2" value="226"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.659" spread="2.0818"/>
                    <measurement group_id="O2" value="-0.507" spread="1.9051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (&lt;50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Difference in LSM</param_type>
            <param_value>1.167</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.797</ci_lower_limit>
            <ci_upper_limit>1.536</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Hip BMD at Week 96</title>
        <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
        <time_frame>Baseline; Week 96</time_frame>
        <population>Participants in the Hip DXA Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Hip BMD at Week 96</title>
          <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
          <population>Participants in the Hip DXA Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="224"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.157" spread="2.8501"/>
                    <measurement group_id="O2" value="0.180" spread="2.6813"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (&lt;50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0002</p_value>
            <method>ANOVA</method>
            <param_type>Difference in LSM</param_type>
            <param_value>0.977</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.465</ci_lower_limit>
            <ci_upper_limit>1.490</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Spine BMD at Week 48</title>
        <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Participants in the Spine DXA Analysis Set (included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing baseline spine BMD values) with available data were analysed. Participants were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Spine BMD at Week 48</title>
          <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
          <population>Participants in the Spine DXA Analysis Set (included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing baseline spine BMD values) with available data were analysed. Participants were analyzed according to the treatment they actually received.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.743" spread="3.4674"/>
                    <measurement group_id="O2" value="-0.138" spread="3.1072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (&lt;50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>ANOVA</method>
            <param_type>Difference in LSM</param_type>
            <param_value>1.881</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.275</ci_lower_limit>
            <ci_upper_limit>2.486</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Spine BMD at Week 96</title>
        <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
        <time_frame>Baseline; Week 96</time_frame>
        <population>Participants in the Spine DXA Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Spine BMD at Week 96</title>
          <description>Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.</description>
          <population>Participants in the Spine DXA Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="229"/>
                <count group_id="O2" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.330" spread="3.9301"/>
                    <measurement group_id="O2" value="1.726" spread="3.8224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>P-value, difference in LSM, and its 95% CI were from ANOVA with baseline age groups (&lt;50, ≥ 50 years), baseline HBeAg status, and treatment group as fixed effects in the model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0970</p_value>
            <method>ANOVA</method>
            <param_type>Difference in LSM</param_type>
            <param_value>0.604</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.110</ci_lower_limit>
            <ci_upper_limit>1.317</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48</title>
        <description>Cockcroft-Gault formula is as follows:&#xD;
For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)&#xD;
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).&#xD;
Change from baseline was calculated as the value at Week 48 minus the value at Baseline.</description>
        <time_frame>Baseline; Week 48</time_frame>
        <population>Participants in the Safety Analysis Set (included all randomized participants who received at least 1 dose of study drug) with available data were analyzed. Participants were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48</title>
          <description>Cockcroft-Gault formula is as follows:&#xD;
For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)&#xD;
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).&#xD;
Change from baseline was calculated as the value at Week 48 minus the value at Baseline.</description>
          <population>Participants in the Safety Analysis Set (included all randomized participants who received at least 1 dose of study drug) with available data were analyzed. Participants were analyzed according to the treatment they actually received.</population>
          <units>mL/min</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="234"/>
                <count group_id="O2" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.240" lower_limit="-3.957" upper_limit="7.704"/>
                    <measurement group_id="O2" value="-1.722" lower_limit="-7.020" upper_limit="2.634"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <p_value_desc>P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.</p_value_desc>
            <method>Wilcoxon rank sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in eGFR-CG at Week 96</title>
        <description>Cockcroft-Gault formula is as follows:&#xD;
For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)&#xD;
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).&#xD;
Change from baseline was calculated as the value at Week 96 minus the value at Baseline.</description>
        <time_frame>Baseline; Week 96</time_frame>
        <population>Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>TAF 25 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
          <group group_id="O2">
            <title>TDF 300 mg</title>
            <description>Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase. Participants who completed DB treatment and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in eGFR-CG at Week 96</title>
          <description>Cockcroft-Gault formula is as follows:&#xD;
For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)&#xD;
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).&#xD;
Change from baseline was calculated as the value at Week 96 minus the value at Baseline.</description>
          <population>Participants in the Safety Analysis Set with available data were analyzed. Participants were analyzed according to the treatment they actually received.</population>
          <units>mL/min</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="232"/>
                <count group_id="O2" value="232"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.626" lower_limit="-4.580" upper_limit="6.952"/>
                    <measurement group_id="O2" value="0.544" lower_limit="-5.227" upper_limit="7.678"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7535</p_value>
            <p_value_desc>P-values were from the 2-sided Wilcoxon rank sum test to compare the 2 treatment groups.</p_value_desc>
            <method>Wilcoxon rank sum test</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-Cause Mortality: First dose date up to 161 weeks (up to approximately 3 years); Adverse Events: First dose date up to the last dose (maximum: 105 weeks) plus 3 days</time_frame>
      <desc>The Safety Analysis Set included all randomized participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>TAF 25 mg</title>
          <description>Adverse events reported in this group occurred during the DB phase. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TAF 25 mg tablet orally once daily, and placebo to match TDF once daily for up to 53 weeks in the DB phase.</description>
        </group>
        <group group_id="E2">
          <title>TDF 300 mg</title>
          <description>Adverse events reported in this group occurred during the DB phase. Participants who were virologically suppressed and taking TDF 300 mg tablet orally once daily received TDF 300 mg tablet orally once daily, and placebo to match TAF once daily for up to 50 weeks in the DB phase.</description>
        </group>
        <group group_id="E3">
          <title>OLE TAF 25 mg From TAF 25 mg</title>
          <description>Adverse events reported in this group occurred during the OLE phase. Participants who completed TAF treatment in the DB phase and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
        </group>
        <group group_id="E4">
          <title>OLE TAF 25 mg From TDF 300 mg</title>
          <description>Adverse events reported in this group occurred during the OLE phase. Participants who completed TDF treatment in the DB phase and were willing to enter in the OLE phase, received TAF 25 mg tablet orally once daily for up to 52 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatic mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Pneumonia necrotising</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Lung squamous cell carcinoma stage II</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Testicular neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar I disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Homicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="237"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="237"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="243"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="245"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="235"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="237"/>
              </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>After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:&#xD;
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or&#xD;
The study has been completed at all study sites for at least 2 years</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gilead Clinical Study Information Center</name_or_title>
      <organization>Gilead Sciences</organization>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@gilead.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02979613
org study id: GS-US-320-4018
secondary id: 2016-003632-20
nct id: NCT02979613
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of switching to tenofovir alafenamide (TAF) versus continuing tenofovir disoproxil fumarate
      (TDF) in virologically suppressed adults with chronic hepatitis B virus (HBV) infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Hepatitis B Virus (HBV) DNA Levels ≥ 20 IU/mL at Week 48, as Determined by the Modified United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
time frame: Week 48
description: The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 48 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:
Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 48 analysis window (from Day 295 to Day 378, inclusive), or
Did not have on-treatment HBV DNA data available in the Week 48 analysis window and
Discontinued study drug prior to or in the Week 48 analysis window due to lack of efficacy, or
Discontinued study drug prior to or in the Week 48 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL
measure: Percentage of Participants With HBV DNA Levels ≥ 20 IU/mL at Week 96, as Determined by the Modified US FDA-Defined Snapshot Algorithm
time frame: Week 96
description: The percentage of participants with HBV DNA ≥ 20 IU/mL at Week 96 was analyzed using the modified US FDA-defined snapshot algorithm, which included participants who:
Had the last available on-treatment HBV DNA ≥ 20 IU/mL in the Week 96 analysis window (from Day 589 to Day 840, inclusive), or
Did not have on-treatment HBV DNA data available in the Week 96 analysis window and
Discontinued study drug prior to or in the Week 96 analysis window due to lack of efficacy, or
Discontinued study drug prior to or in the Week 96 analysis window due to reason other than lack of efficacy and had the last available on-treatment HBV DNA ≥ 20 IU/mL
measure: Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 48
time frame: Weeks 48
description: The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. Missing=Failure (M = F) approach was used for analysis.
measure: Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 48
time frame: Week 48
description: The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 48 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 48, was handled by M = F, and Missing=Excluded (M = E) approaches.
measure: Percentage of Participants With HBV DNA Levels < 20 IU/mL at Week 96
time frame: Week 96
description: The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. M = F approach was used for analysis.
measure: Percentage of Participants With HBV DNA Levels < 20 IU/mL (Target Detected/Not Detected) at Week 96
time frame: Week 96
description: The percentage of participants with HBV DNA < 20 IU/mL at Week 96 was analyzed, which included participants who have the last available on-treatment HBV DNA, 20 IU/mL in the Week 96 analysis window. The method of determining percentage of participants with HBV DNA levels <20 IU/mL (target detected/not detected i.e., lower limit of detection) at Week 96, was handled by Missing=Failure (M = F), and Missing=Excluded (M = E) approaches.
measure: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 48
time frame: Week 48
description: HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.
measure: Percentage of Participants With HBeAg Seroconversion at Week 48
time frame: Week 48
description: HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
measure: Percentage of Participants With HBeAg Loss at Week 96
time frame: Week 96
description: HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline visit with baseline HBeAb negative or missing. The M = F approach was used for this analysis.
measure: Percentage of Participants With HBeAg Seroconversion at Week 96
time frame: Week 96
description: HBeAg seroconversion was defined as HBeAg loss and HBeAb changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
measure: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
time frame: Week 48
description: HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.
measure: Percentage of Participants With HBsAg Seroconversion at Week 48
time frame: Week 48
description: HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
measure: Percentage of Participants With HBsAg Loss at Week 96
time frame: Week 96
description: HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline visit with baseline HBsAb negative or missing. The M = F approach was used for this analysis.
measure: Percentage of Participants With HBsAg Seroconversion at Week 96
time frame: Week 96
description: HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.
measure: Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 48 (by Central Laboratory and the American Association for the Study of Liver Diseases [AASLD] Criteria)
time frame: Week 48
description: Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
measure: Percentage of Participants With Normalized ALT at Week 48 (by Central Laboratory and AASLD Criteria)
time frame: Week 48
description: ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
measure: Percentage of Participants With Normal ALT at Week 96 (by Central Laboratory and the AASLD Criteria)
time frame: Week 96
description: Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
measure: Percentage of Participants With Normalized ALT at Week 96 (by Central Laboratory and AASLD Criteria)
time frame: Week 96
description: ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. M = F approach was used for analysis.
measure: Change From Baseline in FibroTest® Score at Week 48
time frame: Baseline; Week 48
description: The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
measure: Change From Baseline in FibroTest® Score at Week 96
time frame: Baseline; Week 96
description: The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
measure: Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
time frame: Baseline; Week 48
description: Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
measure: Percent Change From Baseline in Hip BMD at Week 96
time frame: Baseline; Week 96
description: Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
measure: Percent Change From Baseline in Spine BMD at Week 48
time frame: Baseline; Week 48
description: Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
measure: Percent Change From Baseline in Spine BMD at Week 96
time frame: Baseline; Week 96
description: Percent Change = Change from baseline at a postbaseline visit/baseline * 100%.
measure: Change From Baseline in Estimated Glomerular Filtration Rate Calculated Using the Cockcroft-Gault Equation (eGFR-CG) at Week 48
time frame: Baseline; Week 48
description: Cockcroft-Gault formula is as follows:
For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).
Change from baseline was calculated as the value at Week 48 minus the value at Baseline.
measure: Change From Baseline in eGFR-CG at Week 96
time frame: Baseline; Week 96
description: Cockcroft-Gault formula is as follows:
For men: Glomerular filtration rate (GFR) = (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL)
For women: GFR = 0.85 * (140 - age in years) * body weight in kg / 72 * serum creatinine (mg/dL).
Change from baseline was calculated as the value at Week 96 minus the value at Baseline.
arm group label: TAF 25 mg
arm group type: Experimental
description: Double-blind (DB) phase: TAF 25 mg + TDF placebo for up to 53 weeks. Open-label extension (OLE) phase: TAF 25 mg for up to 52 weeks.
arm group label: TDF 300 mg
arm group type: Active Comparator
description: DB phase: TDF 300 mg + TAF placebo for up to 50 weeks. OLE phase: TAF 25 mg for up to 52 weeks.
intervention type: Drug
intervention name: TAF
description: 25 mg tablet administered orally once daily
arm group label: TAF 25 mg
arm group label: TDF 300 mg
other name: Vemlidy®
other name: GS-7340
intervention type: Drug
intervention name: TDF
description: 300 mg tablet administered orally once daily
arm group label: TDF 300 mg
other name: Viread®
intervention type: Drug
intervention name: TAF Placebo
description: Tablet administered orally once daily
arm group label: TDF 300 mg
intervention type: Drug
intervention name: TDF Placebo
description: Tablet administered orally once daily
arm group label: TAF 25 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Canada
country: Hong Kong
country: Italy
country: Korea, Republic of
country: Spain
country: Taiwan
country: United Kingdom
country: United States
citation: Lampertico P, Buti M, Fung S, Ahn SH, Chuang WL, Tak WY, Ramji A, Chen CY, Tam E, Bae H, Ma X, Flaherty JF, Gaggar A, Lau A, Liu Y, Wu G, Suri V, Tan SK, Subramanian GM, Trinh H, Yoon SK, Agarwal K, Lim YS, Chan HLY. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in virologically suppressed patients with chronic hepatitis B: a randomised, double-blind, phase 3, multicentre non-inferiority study. Lancet Gastroenterol Hepatol. 2020 May;5(5):441-453. doi: 10.1016/S2468-1253(19)30421-2. Epub 2020 Feb 20.
PMID: 32087795
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
sharing ipd: Yes
ipd description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 