<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/NCT02224456</url>
  </required_header>
  <id_info>
    <org_study_id>201213</org_study_id>
    <nct_id>NCT02224456</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis &amp; Compensated Cirrhosis</brief_title>
  <official_title>A Prospective, Multi-center, Cohort Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) Therapy in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis &amp; Compensated Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver&#xD;
      disease that predisposes patients to the development of hepatocellular carcinoma (HCC).&#xD;
      Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease&#xD;
      progression. Majority of Chinese patients are infected with genotype B and C HBV, which is&#xD;
      different from Caucasian counterparts. This prospective multi-center cohort open-label study&#xD;
      is designed to investigate the long-term effect of TDF on prevention of HCC and disease&#xD;
      progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB&#xD;
      subjects with advanced liver diseases. The study will enrol 240 subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2015</start_date>
  <completion_date type="Actual">December 4, 2020</completion_date>
  <primary_completion_date type="Actual">December 4, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240</measure>
    <time_frame>Week 240</time_frame>
    <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Disease Progression at Week 240</measure>
    <time_frame>Week 240</time_frame>
    <description>Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192</measure>
    <time_frame>Week 48, Week 96, Week 144 and Week 192</time_frame>
    <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240</measure>
    <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240</measure>
    <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240</measure>
    <time_frame>Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) &lt;20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240</measure>
    <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA</measure>
    <time_frame>Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline</measure>
    <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.</measure>
    <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240</measure>
    <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Experienced Viral Breakthrough</measure>
    <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Viral breakthrough was defined as &gt;=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Histological Improvement at Week 216</measure>
    <time_frame>Week 216</time_frame>
    <description>The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cirrhosis Reversal at Week 216</measure>
    <time_frame>Week 216</time_frame>
    <description>Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs</measure>
    <time_frame>Up to Week 240</time_frame>
    <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hemoglobin (Hb)</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Red Blood Cells (RBC)</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chemistry Parameters: Albumin and Total Protein</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
    <description>Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>Tenofovir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive TDF 300 milligrams (mg) tablet once daily for 240 weeks in the study. Subjects who receive add-on rescue treatment may take LAM 100 mg, ETV 0.5 mg or LdT 600 mg per day upon investigator's decision in addition to TDF tablet.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir disoproxil fumarate</intervention_name>
    <description>White, almond-shaped, film-coated tablet containing 300 mg of TDF, debossed with &quot;GILEAD&quot; and &quot;4331&quot; on one side of the tablet.</description>
    <arm_group_label>Tenofovir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-60 years(inclusive);&#xD;
&#xD;
          -  Presence of HBsAg in serum at screening and for at least 6 months before screening&#xD;
             assessment;&#xD;
&#xD;
          -  Serum HBV DNA&gt;=2000 IU/mL if HBeAg positive at screening (with or without ALT&#xD;
             elevation); or serum HBV DNA&gt;=200IU/mL if HBeAg negative at screening (with or without&#xD;
             ALT elevation);&#xD;
&#xD;
          -  Clinically diagnosed as advanced fibrosis or compensated cirrhosis defined as both of&#xD;
             following : liver stiffness measure (LSM) &gt;12.4 kiloPascals (kpa) (ALT&gt; Upper limit of&#xD;
             normal [ULN]) or LSM&gt;9.0 kpa (ALT&lt;=ULN); One of following: Liver biopsy showing&#xD;
             advanced fibrosis or cirrhosis (Ishak score &gt;=4, within the previous 6 months before&#xD;
             screening and provided that no treatment likely to improve liver histology has been&#xD;
             taken since). The slides must be available for review by an independent&#xD;
             histopathologist; Endoscopy-proven gastroesophageal or gastric varices, non-cirrhotic&#xD;
             portal hypertension excluded; Abdominal ultrasound or CT found changes indicating&#xD;
             cirrhosis, irregular liver surface or nodularity, with/without splenomegaly (depth of&#xD;
             spleen&gt;4.0cm or spleen length&gt;13cm); Blood platelets &lt;100 x10^9/L (and other causes of&#xD;
             thrombocytopenia excluded);&#xD;
&#xD;
          -  Ability to give written informed consent;&#xD;
&#xD;
          -  A female is eligible to enter and participate in this study if she is of:&#xD;
             non-childbearing potential (i.e., physiologically incapable of becoming pregnant,&#xD;
             including any female who is post-menopausal), or Child-bearing potential, has a&#xD;
             negative urine pregnancy test at screening, and agrees to one of the following methods&#xD;
             for avoidance of pregnancy during the period of the study and until 30 days after last&#xD;
             dose of study medication: Oral contraceptive, either combined or progestogen alone;&#xD;
             Injectable progestogen; Implants of levonorgestrel; Oestrogenic vaginal ring;&#xD;
             Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system&#xD;
             (IUS) showing that the expected failure rate is less than 1% per year as stated in the&#xD;
             IUD or IUS product label; Has a male partner who is sterilised; Double barrier method:&#xD;
             condom and an occlusive cap (diaphragm orcervical/vault caps) with a vaginal&#xD;
             spermicidal agent (foam/gel/film /cream/suppository).&#xD;
&#xD;
          -  Agreement not to participate in any other investigational trials or to undertake other&#xD;
             HBV systemic antiviral or interferon (IFN) regimens during participation in this&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatocellular carcinoma as evidenced by one of the following: Suspicious foci on&#xD;
             ultrasound or radiological examination; Normal ultrasound serum alpha-fetoprotein &gt;50&#xD;
             nanograms (ng)/mL at screening.&#xD;
&#xD;
          -  Serum ALT &gt;10 times ULN at screening or history of acute exacerbation leading to&#xD;
             transient decompensation;&#xD;
&#xD;
          -  Documented co-infection with hepatitis A (HAV), hepatitis C (HCV), hepatitis delta&#xD;
             virus (HDV), hepatitis E virus (HEV) or human immunodeficiency virus (HIV). For HCV&#xD;
             co-infection, subjects who are anti-HCV positive and in whom HCV ribonucleic acid&#xD;
             (RNA) is undetectable are considered to be not eligible for enrolment.&#xD;
&#xD;
          -  Evidence of active liver disease due to autoimmune hepatitis (antinuclear antibody&#xD;
             (ANA) titre &gt;1:160).&#xD;
&#xD;
          -  Decompensated liver disease as indicated by any of the following: serum bilirubin &gt;1.5&#xD;
             xULN prothrombin time activity &lt;60% or International normalized ratio (INR)&gt;1.5; serum&#xD;
             albumin &lt;32 grams per liter (g/L); history of previous clinical hepatic decompensation&#xD;
             (e.g., ascites, variceal bleeding, or encephalopathy);&#xD;
&#xD;
          -  Planned for liver transplantation or previous liver transplantation;&#xD;
&#xD;
          -  Creatinine clearance less than 70 mL/minute (min);&#xD;
&#xD;
          -  Haemoglobin &lt;10 g/deciliter (dL), white blood cell (WBC) count &lt;1.5 x 10^9/liter (L),&#xD;
             platelets &lt;=50 x 10^9/L;&#xD;
&#xD;
          -  Any serious or active medical or psychiatric illnesses other than hepatitis B which,&#xD;
             in the opinion of the Investigator, would interfere with subject treatment, assessment&#xD;
             or compliance with the protocol. This would include any uncontrolled clinically&#xD;
             significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic&#xD;
             (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders,&#xD;
             pathological fractures or cancer;&#xD;
&#xD;
          -  Active alcohol or drug abuse or history of alcohol or drug abuse considered by the&#xD;
             Investigator to be sufficient to hinder compliance with treatment, participation in&#xD;
             the study or interpretation of results;&#xD;
&#xD;
          -  A female who is breastfeeding or plan to breastfeed;&#xD;
&#xD;
          -  Use of immunosuppressive therapy, immunomodulatory therapy (including IFN or thymosin&#xD;
             alpha), systemic cytotoxic agents, chronic antiviral agents including Chinese herbal&#xD;
             medicines known to have activity against HBV (e.g., lamivudine (LAM), adefovir,&#xD;
             entecavir (ETV), telbivudine (LdT) or hepatitis B immunoglobulin (HBIg)) within the&#xD;
             previous 6 months prior to screening into this study;&#xD;
&#xD;
          -  Have ever received TDF or any medicinal products containing the above mentioned&#xD;
             antiviral agents or any investigative anti-HBV treatments (e.g., emtricitabine (FTC),&#xD;
             (2R,4R)-4-(2,6-Diaminopurin-9-yl)-1,3-dioxolan-2-yl]methanol (DAPD) and&#xD;
             1-(2-fluoro-5-methyl-beta, Larabinofuranosyl) uracil (L-FMAU));&#xD;
&#xD;
          -  History of hypersensitivity to nucleoside and/or nucleotide analogues and/or any&#xD;
             component of study medication;&#xD;
&#xD;
          -  Therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotercin B, vancomycin,&#xD;
             cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal&#xD;
             excretion (e.g., probenecid) within 2 months prior to study screening or the&#xD;
             expectation that subject will receive any of these during the course of the study;&#xD;
&#xD;
          -  Inability to comply with study requirements as determined by the study Investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Xian</city>
        <state>Shanxi</state>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chongqing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hangzhou</city>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jinan</city>
        <zip>250021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shanghai</city>
        <zip>201508</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taiyuan</city>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Xi'an</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>November 26, 2021</results_first_submitted>
  <results_first_submitted_qc>November 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 14, 2022</results_first_posted>
  <last_update_submitted>November 26, 2021</last_update_submitted>
  <last_update_submitted_qc>November 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tenofovir disoproxil fumarate</keyword>
  <keyword>hepatocellular carcinoma</keyword>
  <keyword>chronic hepatitis B</keyword>
  <keyword>Cirrhosis</keyword>
  <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>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02224456/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 26, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT02224456/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted to evaluate the efficacy and safety of 300 milligram (mg) Tenofovir Disoproxil Fumarate (TDF) therapy in Chinese chronic hepatitis B (CHB) participants with advanced fibrosis and compensated cirrhosis</recruitment_details>
      <pre_assignment_details>A total of 266 participants were screened, of which 197 entered the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Tenofovir Disoproxil Fumarate 300 mg</title>
          <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="161"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Treatment Interruptions of ≥28 days</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics is presented for modified Intent-to-treat (mITT) Population which consisted of all participants who received at least one dose of study medication. 2 participants did not receive TDF treatment thus excluded from mITT Population</population>
      <group_list>
        <group group_id="B1">
          <title>Tenofovir Disoproxil Fumarate 300 mg</title>
          <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="195"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Baseline characteristics is presented for mITT Population which consisted of all participants who received at least one dose of study medication. 2 participants did not receive TDF treatment thus excluded from mITT Population</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.3" spread="9.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Baseline characteristics is presented for mITT Population which consisted of all participants who received at least one dose of study medication. 2 participants did not receive TDF treatment thus excluded from mITT Population</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Baseline characteristics is presented for mITT Population which consisted of all participants who received at least one dose of study medication. 2 participants did not receive TDF treatment thus excluded from mITT Population</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240</title>
        <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).</description>
        <time_frame>Week 240</time_frame>
        <population>Modified Intent-to-treat (mITT) Population consisted of all recruited participants who received at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240</title>
          <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).</description>
          <population>Modified Intent-to-treat (mITT) Population consisted of all recruited participants who received at least one dose of study medication.</population>
          <units>Events per person-year</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Disease Progression at Week 240</title>
        <description>Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.</description>
        <time_frame>Week 240</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Progression at Week 240</title>
          <description>Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.</description>
          <population>mITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192</title>
        <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).</description>
        <time_frame>Week 48, Week 96, Week 144 and Week 192</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192</title>
          <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).</description>
          <population>mITT Population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240</title>
        <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method).</description>
        <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240</title>
          <description>The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules &gt;2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules &gt;1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method).</description>
          <population>mITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">NA indicates that 95% CI could not be calculated due to insufficient participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">NA indicates that 95% CI could not be calculated due to insufficient participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="0.0" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="1.4" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="2.1" upper_limit="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240</title>
        <description>Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).</description>
        <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240</title>
          <description>Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).</description>
          <population>mITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="0.0" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" lower_limit="0.1" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="1.1" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="3.3" upper_limit="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="3.3" upper_limit="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240</title>
        <description>Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value</description>
        <time_frame>Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240</title>
          <description>Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.</population>
          <units>Kilopascals</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="182"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=182</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="4.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n= 176</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="5.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n= 175</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="5.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=167</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.1" spread="7.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n= 131</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.2" spread="5.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) &lt;20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240</title>
        <description>Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.</description>
        <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) &lt;20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240</title>
          <description>Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.2" lower_limit="75.3" upper_limit="87.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.8" lower_limit="84.1" upper_limit="93.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.1" lower_limit="90.4" upper_limit="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=174</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" lower_limit="95.2" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.4" lower_limit="97.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA</title>
        <description>Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA</title>
          <description>Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.</population>
          <units>Log 10 (IU/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=174</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.2" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" spread="1.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline</title>
        <description>Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.</description>
        <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline</title>
          <description>Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=97</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.9" lower_limit="53.8" upper_limit="74.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n= 97</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.0" lower_limit="56.0" upper_limit="75.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n=96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.8" lower_limit="61.2" upper_limit="80.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=93</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.8" lower_limit="74.6" upper_limit="91.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n=87</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.8" lower_limit="74.2" upper_limit="91.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.</title>
        <description>Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.</description>
        <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.</title>
          <description>Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, HBeAg Loss, n=94</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" lower_limit="9.8" upper_limit="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, HBeAg Seroconversion, n=94</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" lower_limit="3.1" upper_limit="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, HBeAg , n=94</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0" lower_limit="22.9" upper_limit="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, HBeAg Seroconversion, n=94</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" lower_limit="7.2" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, HBeAg Loss, n=90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6" lower_limit="24.5" upper_limit="45.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, HBeAg Seroconversion, n=90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" lower_limit="6.5" upper_limit="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, HBeAg Loss, n=90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8" lower_limit="36.4" upper_limit="58.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, HBeAg Seroconversion, n=90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="8.3" upper_limit="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, HBeAg Loss, n=82</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.2" lower_limit="38.7" upper_limit="61.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, HBeAg Seroconversion, n=82</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" lower_limit="13.1" upper_limit="32.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240</title>
        <description>Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.</description>
        <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240</title>
          <description>Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, HBsAg Loss, n=97</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, HBsAg Seroconversion, n=97</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.0" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, HBsAg , n=93</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, HBsAg Seroconversion, n=93</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, HBsAg Loss, n=93</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="0.0" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, HBsAg Seroconversion, n=93</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, HBsAg Loss, n=89</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="0.0" upper_limit="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, HBsAg Seroconversion, n=89</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="0.0" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, HBsAg Loss, n=77</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="0.0" upper_limit="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, HBsAg Seroconversion, n=77</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Experienced Viral Breakthrough</title>
        <description>Viral breakthrough was defined as &gt;=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.</description>
        <time_frame>Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Experienced Viral Breakthrough</title>
          <description>Viral breakthrough was defined as &gt;=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles.)</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=195</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">NA indicates that 95% CI could not be calculated due to insufficient participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n=195</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="NA" upper_limit="NA">NA indicates that 95% CI could not be calculated due to insufficient participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.0" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=180</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.0" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n=161</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.0" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Histological Improvement at Week 216</title>
        <description>The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.</description>
        <time_frame>Week 216</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Histological Improvement at Week 216</title>
          <description>The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.2" lower_limit="26.0" upper_limit="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cirrhosis Reversal at Week 216</title>
        <description>Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.</description>
        <time_frame>Week 216</time_frame>
        <population>mITT Population. Only those participants with data available at the specified data points were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cirrhosis Reversal at Week 216</title>
          <description>Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.</description>
          <population>mITT Population. Only those participants with data available at the specified data points were analyzed</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" lower_limit="23.0" upper_limit="60.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs</title>
        <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.</description>
        <time_frame>Up to Week 240</time_frame>
        <population>Safety Analysis Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs</title>
          <description>An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.</description>
          <population>Safety Analysis Population was defined as all participants who received at least one dose of study medication and have at least one post Baseline safety assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets</title>
        <description>Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets</title>
          <description>Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>10^9 cells per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, WBC, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="1.264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, WBC, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.09" spread="1.380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, WBC, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.12" spread="1.378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, WBC, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="1.412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, WBC, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="1.434"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Neutrophils, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.08" spread="1.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Neutrophils, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="1.184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Neutrophils, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="1.162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Neutrophils, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.26" spread="1.197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Neutrophils, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="1.194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Lymphocytes, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.438"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Lymphocytes, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.06" spread="0.511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Lymphocytes, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="0.422"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Lymphocytes, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.10" spread="0.442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Lymphocytes, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.483"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Monocytes, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.032" spread="0.1056"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Monocytes, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.033" spread="0.1113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Monocytes, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.035" spread="0.1244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Monocytes, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.025" spread="0.1162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Monocytes, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.005" spread="0.1664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Eosinophils, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Eosinophils, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Eosinophils, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.237"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Eosinophils, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Eosinophils, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.03" spread="0.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Basophils, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.017"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Basophils, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.019"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Basophils, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Basophils, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Basophils, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.033"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Platelets, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="31.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Platelets, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="32.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Platelets, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" spread="42.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Platelets, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.7" spread="42.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Platelets, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="38.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hemoglobin (Hb)</title>
        <description>Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin (Hb)</title>
          <description>Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>Grams per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="10.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="11.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="11.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="12.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="12.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Red Blood Cells (RBC)</title>
        <description>Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Red Blood Cells (RBC)</title>
          <description>Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>Trillion cells per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.11" spread="0.306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.13" spread="0.344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="0.340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=179</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="179"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" spread="0.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n=160</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)</title>
        <description>Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)</title>
          <description>Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>Units per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, ALT, n=190</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.98" spread="59.452"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, ALT, n=187</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.99" spread="56.983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, ALT, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.99" spread="56.983"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, ALT, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.79" spread="57.955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, ALT, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.02" spread="63.157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, AST, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.69" spread="36.674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, AST, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.97" spread="36.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, AST, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.10" spread="36.809"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, AST, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.82" spread="36.312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, AST, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.24" spread="43.908"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, ALP, n=190</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.18" spread="20.288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, ALP, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.60" spread="28.233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, ALP, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.20" spread="26.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, ALP, n=177</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.94" spread="31.604"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, ALP, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.68" spread="27.596"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, GGT, n=190</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.88" spread="32.753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, GGT, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.20" spread="34.866"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, GGT, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.69" spread="39.764"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, GGT, n=175</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.07" spread="38.609"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, GGT, n=152</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.26" spread="42.932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48 CK, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.51" spread="103.515"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, CK, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.77" spread="141.961"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, CK, n=182</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="182"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.96" spread="101.897"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, CK, n=173</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.72" spread="106.986"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, CK, n=156</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.79" spread="105.349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, LDH, n=187</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.62" spread="52.851"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, LDH, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.21" spread="48.112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, LDH, n=180</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.34" spread="73.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, LDH, n=172</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.45" spread="87.931"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, LDH, n=155</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.79" spread="87.464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine</title>
        <description>Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine</title>
          <description>Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>Micromoles per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, total bilirubin, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.485" spread="7.1347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, total bilirubin, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.823" spread="6.7167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, total bilirubin, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.665" spread="7.1281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, total bilirubin, n=177</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.791" spread="6.9230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, total bilirubin, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.772" spread="6.9786"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, direct bilirubin, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.296" spread="3.1229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, direct bilirubin, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.462" spread="3.1875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, direct bilirubin, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.713" spread="3.4898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, direct bilirubin, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.780" spread="3.5942"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, direct bilirubin, n=157</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.599" spread="3.5608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, serum creatinine, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="7.020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, serum creatinine, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" spread="7.597"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, serum creatinine, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="9.122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, serum creatinine, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="8.591"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, serum creatinine, n=159</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.35" spread="9.879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chemistry Parameters: Albumin and Total Protein</title>
        <description>Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameters: Albumin and Total Protein</title>
          <description>Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>Grams per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, albumin, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.06" spread="3.063"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, albumin, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.23" spread="3.313"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, albumin, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.86" spread="3.675"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, albumin, n=175</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.65" spread="3.780"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, albumin, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.81" spread="3.790"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, total protein, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.01" spread="5.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, total protein, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.21" spread="5.397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, total protein, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="5.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, total protein, n=175</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.94" spread="5.175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, total protein, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.61" spread="5.829"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose</title>
        <description>Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose</title>
          <description>Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>Millimoles per liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, BUN, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.046" spread="1.1067"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, BUN, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="1.1875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, BUN, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.037" spread="1.0892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, BUN, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.143" spread="1.1234"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, BUN, n=155</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.131" spread="1.1358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Potassium, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.001" spread="0.3703"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Potassium, n=186</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.002" spread="0.3230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Potassium, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.039" spread="0.3871"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Potassium, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.015" spread="0.4223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Potassium, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.013" spread="0.3946"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Sodium, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.21" spread="3.495"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Sodium, n=186</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="3.121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Sodium, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="2.730"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Sodium, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="2.998"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Sodium, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="2.707"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Chloridion, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="3.600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Chloridion, n=186</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="3.535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Chloridion, n=183</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="183"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="3.492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Chloridion, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="3.142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Chloridion, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="3.364"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Phosphorus, n=190</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.044" spread="0.1724"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Phosphorus, n=187</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.038" spread="0.1632"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Phosphorus, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.037" spread="0.1955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Phosphorus, n=175</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.059" spread="0.1876"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Phosphorus, n=159</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.042" spread="0.2009"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Calcium, n=190</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.023" spread="0.1513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Calcium, n=187</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="187"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.1652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Calcium, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.022" spread="0.1605"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Calcium, n=178</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.004" spread="0.1470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Calcium, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.1558"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48, Fasting Blood Glucose, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.162" spread="0.7154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, Fasting Blood Glucose, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.109" spread="0.7139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, Fasting Blood Glucose, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.094" spread="0.8979"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, Fasting Blood Glucose, n=177</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.052" spread="0.7548"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, Fasting Blood Glucose, n=158</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.052" spread="1.2197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate</title>
        <description>Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate</title>
          <description>Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>Milliliter per minute (mL/min)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=190</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.064" spread="11.5995"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.214" spread="12.7883"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n=184</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="184"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.324" spread="15.3937"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=177</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.599" spread="13.8858"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n=155</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.658" spread="16.5351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)</title>
        <description>Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240</time_frame>
        <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate 300 mg</title>
            <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)</title>
          <description>Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>Safety analysis Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).</population>
          <units>mL/minute per 1.73 square meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 48, n=191</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.86" spread="6.581"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 96, n=188</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="188"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.87" spread="7.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 144, n=185</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.68" spread="8.368"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 192, n=180</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.06" spread="8.442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 240, n=161</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.42" spread="9.609"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All cause mortality, non-serious TEAEs and serious TEAEs were collected up to 240 weeks from the start of the treatment.</time_frame>
      <desc>Safety analysis population was used to collect the adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Tenofovir Disoproxil Fumarate 300 mg</title>
          <description>Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersplenism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Rheumatic heart disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Post procedural bile leak</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Tibia fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Chest X-ray abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rheumatic fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Ovarian germ cell teratoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine adhesions</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Rhinitis hypertrophic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.1</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="129" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Retinal vein occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Abdominal mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Dysbacteriosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Haemorrhoids thrombosed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Intestinal polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hepatic pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </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="36" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Myringitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Tonsillitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Ligament injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Skin wound</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Alpha 1 foetoprotein increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Red blood cells urine positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hepatitis B DNA increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Blood urine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hypermagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </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="4" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Renal injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Hypertonic bladder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Uterine enlargement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Pelvic fluid collection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Breast hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Menstruation delayed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Nasal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Leukoderma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="195"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Reponse Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224456
org study id: 201213
nct id: NCT02224456
lead sponsor: 
has dmc: No
Chronic Hepatitis B infection (CHB) is known as the most frequently identified cause of liver
      disease that predisposes patients to the development of hepatocellular carcinoma (HCC).
      Active hepatitis B virus (HBV) replication is the key driver of liver injury and disease
      progression. Majority of Chinese patients are infected with genotype B and C HBV, which is
      different from Caucasian counterparts. This prospective multi-center cohort open-label study
      is designed to investigate the long-term effect of TDF on prevention of HCC and disease
      progression as well as to evaluate the efficacy and safety of long-term TDF in Chinese CHB
      subjects with advanced liver diseases. The study will enrol 240 subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240
time frame: Week 240
description: The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).
measure: Percentage of Participants With Disease Progression at Week 240
time frame: Week 240
description: Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/esophageal varices; 6) hepatocellular carcinoma; 7)liver-related death.
measure: Number of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144 and Week 192
time frame: Week 48, Week 96, Week 144 and Week 192
description: The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).
measure: Percentage of Participants With Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 48, Week 96, Week 144, Week 192 and Week 240
time frame: Week 48, Week 96, Week 144, Week 192 and Week 240
description: The newly diagnosed HCC was defined as HCC cases from Week 24 to Week 240 and the participants were required to meet one of the following criteria: without HCC before Week 24; a histological diagnosis of HCC (i.e. by biopsy or at post-mortem); participants with nodules >2 centimeter (cm), identification of typical HCC characteristics (hyper-vascular in the arterial phase with washout in the portal venous or delayed phases) by 4-phase multi-detector computed tomography (CT) scan or dynamic contrast-enhanced magnetic resonance imaging (MRI); participants with nodules >1 cm, identification of typical HCC characteristics by both techniques (4-phase multi-detector CT and dynamic contrast-enhanced MRI).The cumulative percentage of participants with newly diagnosed Hepatocellular Carcinoma has been presented along with 95% confidence interval (CI) (Wald method).
measure: Percentage of Participants With Disease Progression at Week 48, Week 96, Week 144, Week 192 and Week 240
time frame: Week 48, Week 96, Week 144, Week 192 and Week 240
description: Disease progression was defined as the first occurrence of any one of the following criteria: 1) an increase in Childs-Pugh score of 2 or more points from Baseline; 2) an increase in Childs-Pugh score of 2 or more points, solely based on laboratory parameters (i.e. bilirubin, prothrombin time and/or albumin) confirmed between two consecutive visits at least one month apart; 3) spontaneous bacterial peritonitis (with proven sepsis); 4) renal insufficiency; 5) bleeding gastric/oesophageal varices; 6) hepatocellular carcinoma; 7) liver-related death. The cumulative percentage of participants with disease progression has been presented along with 95% CI (Wald method).
measure: Mean Change From Baseline in Liver Stiffness Measure at Week 48, Week 96, Week 144, Week 192 and Week 240
time frame: Baseline (Day 0), Week 48, Week 96, Week 144, Week 192 and Week 240
description: Liver stiffness measure was obtained by a non-invasive transient elastography using FibroScan. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline is defined as post-dose visit value minus Baseline value
measure: Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <20 International Units Per Milliliter (IU/mL) at Weeks 48, 96, 144, 192 and 240
time frame: Week 48, Week 96, Week 144, Week 192 and Week 240
description: Serum samples were collected for the analysis of HBV DNA levels using Roche Cobas Taqman HBV test. Confidence interval was calculated by normal approximation and continuity correction method.
measure: Change From Baseline in Logarithm to the Base 10 (Log 10) Serum HBV DNA
time frame: Baseline (Day 0) and Week 48, Week 96, Week 144, Week 192 and Week 240
description: Serum samples were collected for the analysis of HBV DNA levels. Baseline is defined as the last assessment (Day 0) before administration of the study drug. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48, Week 96, Week 144, Week 192 and Week 240 in Participants Who Had Abnormal ALT at Baseline
time frame: Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected for evaluation of ALT at indicated time points. ALT normalization is defined as ALT outside the normal range at Baseline and within the normal range at Week 48, Week 96, Week 144, Week 192 and Week 240. Normal range of ALT is 7 to 56 International Units per liter. Percentage of participants with ALT normalization at Weeks 48, 96, 144, 192 and 240 in participants who had abnormal ALT at Baseline (Day 0) have been presented. Confidence interval was calculated using normal approximation and continuity correction method.
measure: Percentage of Hepatitis B e Antigen (HBeAg) Positive Participants Achieving HBeAg Loss, HBeAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240.
time frame: Week 48, Week 96, Week 144, Week 192 and Week 240
description: Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with Positive HBeAg at Baseline (Day 0). It was presented as HBeAg Loss and HBeAg Seroconversion. HBeAg Loss was defined as HBeAg changed to be negative. HBeAg seroconversion was defined as HBeAg changed to negative and HBeAb was positive. Confidence interval was calculated using normal approximation and continuity correction method.
measure: Percentage of HBeAg Negative Participants Achieving HBsAg Loss and HBsAg Seroconversion at Week 48, Week 96, Week 144, Week 192 and Week 240
time frame: Week 48, Week 96, Week 144, Week 192 and Week 240
description: Serological response was assessed at Week 48, Week 96, Week 144, Week 192 and Week 240 in participants with negative HBeAg at Baseline (Day 0). HBsAg Loss was defined as HBsAg changed to be negative. HBsAg seroconversion was defined as HBsAg changed to negative and HBsAb was positive.
measure: Percentage of Participants Who Experienced Viral Breakthrough
time frame: Week 48, Week 96, Week 144, Week 192 and Week 240
description: Viral breakthrough was defined as >=1 log10 increase in HBV DNA from nadir determined by two sequential HBV DNA measurements. Percentage of Participants who experienced viral breakthrough at Week 48, Week 96, Week 144, Week 192 and Week 240 is presented.
measure: Percentage of Participants With Histological Improvement at Week 216
time frame: Week 216
description: The Knodell scoring system, also called the Histologic Activity Index (HAI), classifies liver biopsy specimens according to scores into 4 categories of histologic features: (I) Periportal or periseptal interface hepatitis (piecemeal necrosis) (scores from 0, 1, 2, 3, 4 or 10); (II) Confluent necrosis (scores from 0, 1, 3, 4, 5, 6 or 10); (III) Focal (spotty) lytic necrosis, apoptosis and focal inflammation (scores from 0, 1, 2, 3, 4 or 10); (IV) Portal inflammation (scores from 0, 1, 2, 3, 4 or 10). Histological improvement is considered as a reduction of two or more points in the Knodell necroinflammatory score with no increase in fibrosis.
measure: Percentage of Participants With Cirrhosis Reversal at Week 216
time frame: Week 216
description: Cirrhosis reversal was defined as a reduction of one or more points in the Ishak score with no evidence of cirrhosis. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and Non-serious TEAEs
time frame: Up to Week 240
description: An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is defined as AE that occurred on or after the first dose date of study drug. SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly/birth defect and other situations according to medical or scientific judgement or events possible drug-induced liver injury with hyperbilirubinemia.
measure: Change From Baseline in Hematology Parameters: White Blood Cells (WBC), Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelets
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze the hematology parameters: basophils, eosinophils, WBC, lymphocytes, monocytes, neutrophils and platelets. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline in Hemoglobin (Hb)
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze Hb values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline in Red Blood Cells (RBC)
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze RBC values. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-Glutamyltransferase (GGT), Creatinine Phosphokinase (CK), Lactose Dehydrogenase (LDH)
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze the chemistry parameters: ALT, ALP, AST, GGT, CK, LDH. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline in Chemistry Parameters: Total Bilirubin, Direct Bilirubin, Serum Creatinine
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze the chemistry parameters: total billirubin,direct bilirubin and serum creatinine. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline in Chemistry Parameters: Albumin and Total Protein
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze the chemistry parameters: albumin and total protein. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline in Chemistry Parameter: Blood Urea Nitrogen (BUN), Potassium, Sodium, Chloridion, Phosphorus, Calcium and Fasting Blood Glucose
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze the chemistry parameters: BUN, potassium, sodium, chloridion, phosphorus,calcium and fasting blood glucose. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline in Chemistry Parameters: Creatinine Clearance Rate
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze the chemistry parameters: creatinine clearance rate. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline in Chemistry Parameters: Estimated Glomerular Filtration Rate (eGFR)
time frame: Baseline (Day 0) and at Week 48, Week 96, Week 144, Week 192 and Week 240
description: Blood samples were collected to analyze the chemistry parameters: eGFR. Day 0 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
arm group label: Tenofovir
arm group type: Experimental
description: Subjects will receive TDF 300 milligrams (mg) tablet once daily for 240 weeks in the study. Subjects who receive add-on rescue treatment may take LAM 100 mg, ETV 0.5 mg or LdT 600 mg per day upon investigator's decision in addition to TDF tablet.
intervention type: Drug
intervention name: Tenofovir disoproxil fumarate
description: White, almond-shaped, film-coated tablet containing 300 mg of TDF, debossed with "GILEAD" and "4331" on one side of the tablet.
arm group label: Tenofovir
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Fibrosis
mesh term: Tenofovir
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 