<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/NCT04449029</url>
  </required_header>
  <id_info>
    <org_study_id>209668</org_study_id>
    <nct_id>NCT04449029</nct_id>
  </id_info>
  <brief_title>A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)</brief_title>
  <acronym>B-Clear</acronym>
  <official_title>Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem.&#xD;
      GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and&#xD;
      in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if&#xD;
      treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B&#xD;
      virus surface antigen (HBsAg) less than (&lt;) lower limit of quantitation (LLOQ) and HBV&#xD;
      deoxyribonucleic acid (DNA) &lt;LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In&#xD;
      addition, the study will also evaluate the safety, tolerability, pharmacokinetic and&#xD;
      pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the&#xD;
      efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB;&#xD;
      participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not&#xD;
      currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be&#xD;
      randomized into one of the 4 different parallel arms to receive treatment. The study will&#xD;
      consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440&#xD;
      participants will be enrolled in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Actual">March 18, 2022</completion_date>
  <primary_completion_date type="Actual">March 18, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants with CHB will be divided into two different cohorts; participants on stable nucleos(t)ide treatment and participants not currently on nucleos(t)ide therapy. For each cohort, participants will be randomized into one of the 4 different parallel arms to receive treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will be blinded to the study treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Achieving Sustained Virologic Response (SVR)</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (&lt;) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Achieving HBsAg and HBV DNA&lt;LLOQ</measure>
    <time_frame>Up to Week 26</time_frame>
    <description>Participants achieving HBsAg and HBV DNA levels &lt;LLOQ at the end of treatment (EOT) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Categorical Changes From Baseline in HBsAg Values</measure>
    <time_frame>At Baseline and Week 24</time_frame>
    <description>Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of &lt;0.5, greater than or equal to (&gt;=) 0.5, &gt;=1, &gt;=1.5, and &gt;=3 log10 international units per milliliter (IU/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Categorical Changes From Baseline in HBV DNA Values</measure>
    <time_frame>At Baseline and Week 24</time_frame>
    <description>Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of &lt;1, &gt;=1, &gt;=2, and &gt;=3 log IU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Alanine Aminotransferase (ALT) Normalization</measure>
    <time_frame>At Baseline and Week 24</time_frame>
    <description>The ALT normalization (ALT≤ upper limit of normal [ULN]) over time in absence of rescue medication in participants with baseline ALT&gt;ULN.&#xD;
Participants who achieved ALT normalization were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to ALT Normalization</measure>
    <time_frame>Baseline and up to Week 48</time_frame>
    <description>Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT&gt;ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT &gt;ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb)</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean HBsAg and HBV DNA Level</measure>
    <time_frame>At Baseline, Week 12, and 24</time_frame>
    <description>Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level</measure>
    <time_frame>At Baseline, Week 12, and 24</time_frame>
    <description>Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in HBsAg and HBV DNA Level</measure>
    <time_frame>At Baseline, Week 12, and 24</time_frame>
    <description>Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in HBeAg Level</measure>
    <time_frame>At Baseline, Week 12, and 24</time_frame>
    <description>Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level</measure>
    <time_frame>At Baseline, Week 36, and 48</time_frame>
    <description>Blood samples were collected to assess anti-HBsAg level at indicated timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Anti-HBsAg Level</measure>
    <time_frame>At Baseline, Week 12, and 24</time_frame>
    <description>Blood samples were collected to assess anti-HBsAg level at indicated timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Intensive pharmacokinetic (PK) sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h of GSK3228836.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Maximum Observed Concentration (Cmax) of GSK3228836</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax of GSK3228836.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time of Maximum Observed Concentration (Tmax) of GSK3228836</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax of GSK3228836.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean AUC0-24h of NA Therapies</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Ctau of NA Therapies</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Ctau. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Cmax of NA Therapies</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Tmax of NA Therapies</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Terminal Half-life (t1/2) of GSK3228836</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Blood samples were collected from all participants for t1/2 analysis of GSK3228836. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Ctau of GSK3228836</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Blood samples were collected from all participants for Ctau analysis of GSK3228836 at indicated. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">457</enrollment>
  <condition>Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants on stable nucleos(t)ide treatment will receive 300 milligrams (mg) GSK3228836 once weekly for 24 weeks along with loading dose (LD) of 300 mg GSK3228836 on Day 4 and Day 11.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD/ Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants on stable nucleos(t)ide treatment will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: GSK3228836 300 mg + LD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 24 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: GSK3228836 300 mg + LD/ Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants not currently on nucleos(t)ide therapy will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK3228836</intervention_name>
    <description>GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.</description>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD</arm_group_label>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo</arm_group_label>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD/ Placebo</arm_group_label>
    <arm_group_label>Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD</arm_group_label>
    <arm_group_label>Cohort 2: GSK3228836 300 mg + LD</arm_group_label>
    <arm_group_label>Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo</arm_group_label>
    <arm_group_label>Cohort 2: GSK3228836 300 mg + LD/ Placebo</arm_group_label>
    <arm_group_label>Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.</description>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo</arm_group_label>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD/ Placebo</arm_group_label>
    <arm_group_label>Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD</arm_group_label>
    <arm_group_label>Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo</arm_group_label>
    <arm_group_label>Cohort 2: GSK3228836 300 mg + LD/ Placebo</arm_group_label>
    <arm_group_label>Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nucleos(t)ide therapy</intervention_name>
    <description>Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.</description>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD</arm_group_label>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo</arm_group_label>
    <arm_group_label>Cohort 1: GSK3228836 300 mg + LD/ Placebo</arm_group_label>
    <arm_group_label>Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age at the time of signing the informed consent.&#xD;
&#xD;
          -  Participants who have documented chronic HBV infection greater than equal to (&gt;=6)&#xD;
             months prior to screening and not currently on nucleos(t)ide analogue therapy&#xD;
             population defined as participants who never received HBV treatment (treatment naive)&#xD;
             or must have ended nucleos(t)ide therapy at least 6 months prior to the screening&#xD;
             visit; OR Currently receiving stable nucleos(t)ide analogue therapy population defined&#xD;
             as no changes to their nucleos(t)ide regimen from at least 6 months prior to screening&#xD;
             and with no planned changes to the stable regimen over the duration of the study.&#xD;
&#xD;
          -  Plasma or serum HBsAg concentration &gt;100 international units per milliliter (IU/mL).&#xD;
&#xD;
          -  Plasma or serum HBV DNA concentration: Participants not currently on nucleos(t)ide&#xD;
             analogue therapy, plasma or serum HBV DNA &gt;2000 IU/mL; Participants who are receiving&#xD;
             stable nucleos(t)ide analogue therapy must be adequately suppressed, defined as plasma&#xD;
             or serum HBV DNA &lt;90 IU/mL.&#xD;
&#xD;
          -  ALT for treatment naive participants and for participants who are not currently&#xD;
             receiving treatment: ALT &lt;3 times ULN will be included initially if agreed by the&#xD;
             independent data monitoring committee (IDMC) after review of safety data, the ALT&#xD;
             inclusion criteria may be expanded to include participants with ALT &lt;5 times ULN; ALT&#xD;
             less than equal to (&lt;=2) times ULN for participants who are receiving stable&#xD;
             nucleos(t)ide analogue therapy.&#xD;
&#xD;
          -  Male and/or Female: A male participant is eligible to participate if they agree to the&#xD;
             following during the intervention period and for at least 90 days after the last dose&#xD;
             of study treatment: Refrain from donating sperm AND be abstinent from heterosexual&#xD;
             intercourse as their preferred and usual lifestyle (abstinent on a long term and&#xD;
             persistent basis) and agree to remain abstinent or Must agree to use&#xD;
             contraception/barrier as detailed below: Agree to use a male condom (and should also&#xD;
             be advised of the benefit for a female partner to use a highly effective method of&#xD;
             contraception as a condom may break or leak) when having sexual intercourse with a&#xD;
             woman of childbearing potential who is not currently pregnant. A female participant is&#xD;
             eligible to participate: If she is not pregnant or breastfeeding AND at least one of&#xD;
             the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR&#xD;
             is a WOCBP and using a contraceptive method that is highly effective (with a failure&#xD;
             rate of &lt;1 percent per year), preferably with low user dependency during the&#xD;
             intervention period and for at least 90 days after the last dose of study treatment; A&#xD;
             WOCBP must have both a confirmed menstrual period prior to the first dose of study&#xD;
             intervention (additional evaluation [e.g., amenorrhea in athletes, birth control]&#xD;
             should also be considered) and a negative highly sensitive pregnancy test (urine or&#xD;
             serum) within 24 hours before the first dose of study treatment.&#xD;
&#xD;
          -  Contraceptive use by men or women should be consistent with local regulations&#xD;
             regarding the methods of contraception for those participating in clinical studies.&#xD;
&#xD;
          -  The investigator is responsible for review of medical history, menstrual history, and&#xD;
             recent sexual activity to decrease the risk for inclusion of a woman with an early&#xD;
             undetected pregnancy.&#xD;
&#xD;
          -  Capable of giving signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically significant abnormalities, aside from chronic HBV infection in medical&#xD;
             history (e.g., moderate-severe liver disease other than chronic HBV, acute coronary&#xD;
             syndrome within 6 months of screening, major surgery within 3 months of screening,&#xD;
             significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or&#xD;
             coagulopathy) or physical examination.&#xD;
&#xD;
          -  Co-infection with Current or past history of Hepatitis C virus (HCV), Human&#xD;
             immunodeficiency virus (HIV), Hepatitis D virus (HDV).&#xD;
&#xD;
          -  History of or suspected liver cirrhosis and/or evidence of cirrhosis as determined by&#xD;
             both Aspartate aminotransferase (AST)-Platelet Index (APRI) &gt;2 and FibroSure/FibroTest&#xD;
             result &gt;0.7. If only one parameter (APRI or FibroSure/FibroTest) result is positive, a&#xD;
             discussion with the Medical Monitor is required before inclusion in study is&#xD;
             permitted. Regardless of APRI of Fibrosure/FibroTest score, if the participant meets&#xD;
             one of the following criteria, they will be excluded from the study: Liver biopsy&#xD;
             (i.e., Metavir Score F4); Liver stiffness &gt;12 kilopascals (kPa).&#xD;
&#xD;
          -  Diagnosed or suspected hepatocellular carcinoma as evidenced by the following:&#xD;
             Alpha-fetoprotein concentration &gt;=200 nanogram per milliliter (ng/mL); If the&#xD;
             screening alpha fetoprotein concentration is &gt;=50 ng/mL and &lt;200 ng/mL, the absence of&#xD;
             liver mass must be documented by imaging within 6 months before randomization.&#xD;
&#xD;
          -  History of malignancy within the past 5 years with the exception of specific cancers&#xD;
             that are cured by surgical resection (e.g., skin cancer). Participants under&#xD;
             evaluation for possible malignancy are not eligible.&#xD;
&#xD;
          -  History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g.,&#xD;
             vasculitic rash, skin ulceration, repeated blood detected in urine without identified&#xD;
             cause) or history/presence of other diseases that may be associated with vasculitis&#xD;
             condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing&#xD;
             polychondritis, mononeuritis multiplex).&#xD;
&#xD;
          -  History of extrahepatic disorders possibly related to HBV immune conditions (e.g.,&#xD;
             nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa,&#xD;
             cryoglobulinemia, uncontrolled hypertension).&#xD;
&#xD;
          -  Anti-neutrophil cytoplasmic antibodies (ANCA) at screening by itself won't be an&#xD;
             exclusion criterion, but if results are borderline positive or positive:&#xD;
             myeloperoxidase-ANCA (MPO-ANCA) (Perinuclear antineutrophil cytoplasmic antibodies&#xD;
             [pANCA]) and proteinase 3- ANCA (PR3-ANCA) (Cytoplasmic antineutrophil cytoplasmic&#xD;
             antibodies [cANCA]) analysis will be conducted; A discussion with the Medical Monitor&#xD;
             will be required to review participant's complete medical history to ensure no past&#xD;
             history or current manifestations of a vasculitic/inflammatory/auto-immune condition&#xD;
             before inclusion in study is permitted.&#xD;
&#xD;
          -  Low complement C3 (C3) at screening by itself won't be an exclusion criterion, but if&#xD;
             it is present: A discussion with the Medical Monitor is required to review&#xD;
             participant's complete medical history to ensure no past history or current&#xD;
             manifestations of vasculitic/inflammatory/auto-immune conditions.&#xD;
&#xD;
          -  History of alcohol or drug abuse/dependence: Current alcohol use as judged by&#xD;
             investigator to potentially interfere with participant compliance; History of or&#xD;
             current drug abuse/dependence as judged by the investigator to potentially interfere&#xD;
             with participant compliance. Refers to illicit drugs and substances with abuse&#xD;
             potential. Medications that are used by the participant as directed, whether&#xD;
             over-the-counter or through prescription, are acceptable and would not meet the&#xD;
             exclusion criteria.&#xD;
&#xD;
          -  Currently taking, or took within 3 months of screening, any immunosuppressing drugs&#xD;
             (e.g., prednisone), other than a short course of therapy (&lt;=2 weeks) or&#xD;
             topical/inhaled steroid use.&#xD;
&#xD;
          -  Participants for whom immunosuppressive treatment is not advised, including&#xD;
             therapeutic doses of steroids, will be excluded.&#xD;
&#xD;
          -  Currently taking, or took within 12 months of screening, any interferon-containing&#xD;
             therapy.&#xD;
&#xD;
          -  Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa&#xD;
             inhibitors or anti-platelet agents like clopidogrel).&#xD;
&#xD;
          -  The participant has participated in a clinical trial and has received an&#xD;
             investigational product within the following time period prior to the first dosing day&#xD;
             in the current study: 5 half-lives (if known) or twice the duration (if known) of the&#xD;
             biological effect of the study treatment (whichever is longer) or 90 days (if&#xD;
             half-life or duration is unknown).&#xD;
&#xD;
          -  Prior treatment with any oligonucleotide or small interfering ribonucleic acid (RNA)&#xD;
             (Small interfering RNA [siRNA]) within 12 months prior to the first dosing day.&#xD;
&#xD;
          -  Fridericia's QT correction formula (QTcF) &gt;=450 milliseconds (msec) (if single&#xD;
             electrocardiogram [ECG] at screening shows QTcF&gt;=450 msec, a mean of triplicate&#xD;
             measurements should be used to confirm that participant meets exclusion criterion).&#xD;
&#xD;
          -  Laboratory results as follows: Serum albumin &lt;3.5 grams per deciliter (g/dL),&#xD;
             Glomerular filtration rate (GFR) &lt;60 milliliter per minute per 1.73 square meter&#xD;
             (mL/min /1.73 m^2) as calculated by the Chronic Kidney Disease Epidemiologic&#xD;
             Collaboration (CKD-EPI) formula (for Japan, Japanese Society of Nephrology Chronic&#xD;
             Kidney Disease Initiative [JSN-CKDI equation]), International normalized ratio (INR)&#xD;
             &gt;1.25. Platelet count &lt;140 times 10^9 cells/L, Total bilirubin &gt;1.25 times ULN. For&#xD;
             participants with benign unconjugated hyperbilirubinemia with total bilirubin &gt;1.25&#xD;
             times ULN, discussion for inclusion to the study is required with the Medical Monitor,&#xD;
             Urine albumin to creatinine ratio (ACR) &gt;=0.03 mg/mg (or &gt;=30 mg/g). In the event of&#xD;
             an ACR above this threshold, eligibility may be confirmed by a second measurement. In&#xD;
             cases where participants have low urine albumin and low urine creatinine levels&#xD;
             resulting in a urine ACR calculation &gt;=0.03 mg/mg (or &gt;=30 mg/g), the investigator&#xD;
             should confirm that the participant does not have a history of diabetes, hypertension&#xD;
             or other risk factors that may affect renal function and discuss with the Medical&#xD;
             Monitor, or designee.&#xD;
&#xD;
          -  History of/sensitivity to GSK3228836 or components thereof or a history of drug or&#xD;
             other allergy that, in the opinion of the investigator or Medical Monitor,&#xD;
             contraindicates their participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Buenos Aires</state>
        <zip>C1181ACH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sliven</city>
        <zip>8800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1463</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4Z6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <zip>V8V 3M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 2C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Regina</city>
        <state>Saskatchewan</state>
        <zip>S4P 0W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Québec</city>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chongqing</city>
        <state>Sichuan</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <zip>100015</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beijing</city>
        <zip>100034</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>Guangzhou</city>
        <zip>510000</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>Clichy Cedex</city>
        <zip>92118</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Créteil cedex</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Limoges cedex</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lyon cedex 04</city>
        <zip>69317</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nice cedex 3</city>
        <zip>06202</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10439</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20146</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pokfulam</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Modena</city>
        <state>Emilia-Romagna</state>
        <zip>41126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ehime</city>
        <zip>790-8524</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hiroshima</city>
        <zip>730-8619</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>080-0024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ishikawa</city>
        <zip>920-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ishikawa</city>
        <zip>924-8588</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kagawa</city>
        <zip>760-8557</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>860-8556</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kumamoto</city>
        <zip>862-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miyagi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagasaki</city>
        <zip>856-8562</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>180-8610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>15355</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>06973</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Makati City</city>
        <zip>1229</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quezon City</city>
        <zip>1101</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lancut</city>
        <zip>37-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lublin</city>
        <zip>20-884</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Myslowice</city>
        <zip>41-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Warszawa</city>
        <zip>00-332</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brasov</city>
        <zip>500283</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>030303</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cluj Napoca</city>
        <zip>400162</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400139</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Craiova</city>
        <zip>200515</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Galati</city>
        <zip>800179</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Iasi</city>
        <zip>700116</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Timisoara</city>
        <zip>300310</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454052</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kaliningrad</city>
        <zip>236016</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krasnodar</city>
        <zip>350000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Krasnojarsk</city>
        <zip>660049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>121170</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Moscow</city>
        <zip>125008</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630099</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>191167</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Samara</city>
        <zip>443063</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <zip>190103</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Port Elizabeth</city>
        <state>Eastern Cape</state>
        <zip>6001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ennerdale</city>
        <state>Gauteng</state>
        <zip>1830</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lenasia Johannesburg</city>
        <state>Gauteng</state>
        <zip>1827</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Durban</city>
        <state>KwaZulu- Natal</state>
        <zip>4052</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kwaguqa Emalahleni</city>
        <state>Mpumalanga</state>
        <zip>1039</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Vosloorus Ext 2</city>
        <zip>1475</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28031</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Majadahonda (Madrid)</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chiangmai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Phitsanulok</city>
        <zip>65000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Songkla</city>
        <zip>9110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <zip>WC1E 6JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Newcastle-upon-Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>China</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Yuen MF, Lim SG, Plesniak R, Tsuji K, Janssen HLA, Pojoga C, Gadano A, Popescu CP, Stepanova T, Asselah T, Diaconescu G, Yim HJ, Heo J, Janczewska E, Wong A, Idriz N, Imamura M, Rizzardini G, Takaguchi K, Andreone P, Arbune M, Hou J, Park SJ, Vata A, Cremer J, Elston R, Lukic T, Quinn G, Maynard L, Kendrick S, Plein H, Campbell F, Paff M, Theodore D; B-Clear Study Group. Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection. N Engl J Med. 2022 Nov 24;387(21):1957-1968. doi: 10.1056/NEJMoa2210027. Epub 2022 Nov 8.</citation>
    <PMID>36346079</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <results_first_submitted>March 1, 2023</results_first_submitted>
  <results_first_submitted_qc>April 21, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">May 16, 2023</results_first_posted>
  <last_update_submitted>April 21, 2023</last_update_submitted>
  <last_update_submitted_qc>April 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Hepatitis B</keyword>
  <keyword>GSK3228836</keyword>
  <keyword>Hepatitis B virus surface antigen</keyword>
  <keyword>Nucleos(t)ide therapy</keyword>
  <keyword>Sustained virologic response</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>
  </condition_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 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT04449029/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>April 14, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT04449029/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 457 participants were enrolled in the study. These 457 participants were from 2 different set of populations (referred here after as on nucleos(t)ide [NA] and not on NA therapy). Participants from these subpopulations were randomized in a ratio of 3:3:3:1 into 4 treatment arms for each population (total of 8 arms).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
          <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
        </group>
        <group group_id="P2">
          <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="P3">
          <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
          <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="P5">
          <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
        </group>
        <group group_id="P6">
          <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="P7">
          <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
        </group>
        <group group_id="P8">
          <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 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="68"/>
                <participants group_id="P2" count="68"/>
                <participants group_id="P3" count="68"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="70"/>
                <participants group_id="P6" count="68"/>
                <participants group_id="P7" count="68"/>
                <participants group_id="P8" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="65"/>
                <participants group_id="P2" count="65"/>
                <participants group_id="P3" count="66"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="64"/>
                <participants group_id="P6" count="66"/>
                <participants group_id="P7" count="63"/>
                <participants group_id="P8" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
          <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
        </group>
        <group group_id="B2">
          <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="B3">
          <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
          <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="B5">
          <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
        </group>
        <group group_id="B6">
          <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="B7">
          <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
        </group>
        <group group_id="B8">
          <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="68"/>
            <count group_id="B2" value="68"/>
            <count group_id="B3" value="68"/>
            <count group_id="B4" value="23"/>
            <count group_id="B5" value="70"/>
            <count group_id="B6" value="68"/>
            <count group_id="B7" value="68"/>
            <count group_id="B8" value="24"/>
            <count group_id="B9" value="457"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>YEARS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.0" spread="11.54"/>
                    <measurement group_id="B2" value="46.1" spread="12.60"/>
                    <measurement group_id="B3" value="47.4" spread="11.18"/>
                    <measurement group_id="B4" value="49.8" spread="11.21"/>
                    <measurement group_id="B5" value="44.5" spread="11.10"/>
                    <measurement group_id="B6" value="43.8" spread="9.92"/>
                    <measurement group_id="B7" value="40.7" spread="11.10"/>
                    <measurement group_id="B8" value="42.4" spread="12.02"/>
                    <measurement group_id="B9" value="42.9" spread="10.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="37"/>
                    <measurement group_id="B6" value="27"/>
                    <measurement group_id="B7" value="29"/>
                    <measurement group_id="B8" value="13"/>
                    <measurement group_id="B9" value="168"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="33"/>
                    <measurement group_id="B6" value="41"/>
                    <measurement group_id="B7" value="39"/>
                    <measurement group_id="B8" value="11"/>
                    <measurement group_id="B9" value="289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="37"/>
                    <measurement group_id="B6" value="44"/>
                    <measurement group_id="B7" value="38"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="24"/>
                    <measurement group_id="B6" value="20"/>
                    <measurement group_id="B7" value="24"/>
                    <measurement group_id="B8" value="11"/>
                    <measurement group_id="B9" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Achieving Sustained Virologic Response (SVR)</title>
        <description>The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (&lt;) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The analysis was performed on the Intent to Treat (ITT) Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving Sustained Virologic Response (SVR)</title>
          <description>The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (&lt;) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.</description>
          <population>The analysis was performed on the Intent to Treat (ITT) Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Achieving HBsAg and HBV DNA&lt;LLOQ</title>
        <description>Participants achieving HBsAg and HBV DNA levels &lt;LLOQ at the end of treatment (EOT) were reported.</description>
        <time_frame>Up to Week 26</time_frame>
        <population>The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Achieving HBsAg and HBV DNA&lt;LLOQ</title>
          <description>Participants achieving HBsAg and HBV DNA levels &lt;LLOQ at the end of treatment (EOT) were reported.</description>
          <population>The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="10"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Categorical Changes From Baseline in HBsAg Values</title>
        <description>Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of &lt;0.5, greater than or equal to (&gt;=) 0.5, &gt;=1, &gt;=1.5, and &gt;=3 log10 international units per milliliter (IU/mL).</description>
        <time_frame>At Baseline and Week 24</time_frame>
        <population>The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. One participant from 12+12 weeks on NA therapy arm was randomized in error and is in ITT population but did not contribute any lab data so is not part of the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Categorical Changes From Baseline in HBsAg Values</title>
          <description>Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of &lt;0.5, greater than or equal to (&gt;=) 0.5, &gt;=1, &gt;=1.5, and &gt;=3 log10 international units per milliliter (IU/mL).</description>
          <population>The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. One participant from 12+12 weeks on NA therapy arm was randomized in error and is in ITT population but did not contribute any lab data so is not part of the analysis.</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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HBsAg&lt; LLOQ, at baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="70"/>
                    <count group_id="O6" value="68"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg decline &lt;0.5 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="14"/>
                    <measurement group_id="O7" value="29"/>
                    <measurement group_id="O8" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg decline &gt;=0.5 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="55"/>
                    <measurement group_id="O6" value="48"/>
                    <measurement group_id="O7" value="22"/>
                    <measurement group_id="O8" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg decline &gt;=1 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="17"/>
                    <measurement group_id="O5" value="51"/>
                    <measurement group_id="O6" value="36"/>
                    <measurement group_id="O7" value="18"/>
                    <measurement group_id="O8" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg decline &gt;=1.5 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="15"/>
                    <measurement group_id="O5" value="48"/>
                    <measurement group_id="O6" value="30"/>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg decline &gt;=3 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="35"/>
                    <measurement group_id="O6" value="13"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Categorical Changes From Baseline in HBV DNA Values</title>
        <description>Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of &lt;1, &gt;=1, &gt;=2, and &gt;=3 log IU/mL.</description>
        <time_frame>At Baseline and Week 24</time_frame>
        <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Categorical Changes From Baseline in HBV DNA Values</title>
          <description>Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of &lt;1, &gt;=1, &gt;=2, and &gt;=3 log IU/mL.</description>
          <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.</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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HBV DNA &lt; LLOQ, at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="70"/>
                    <count group_id="O6" value="67"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="66"/>
                    <measurement group_id="O3" value="66"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA decline &lt;1 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="59"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="12"/>
                    <measurement group_id="O7" value="21"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA decline &gt;=1 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="59"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="51"/>
                    <measurement group_id="O6" value="44"/>
                    <measurement group_id="O7" value="30"/>
                    <measurement group_id="O8" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA decline &gt;=2 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="59"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="40"/>
                    <measurement group_id="O6" value="23"/>
                    <measurement group_id="O7" value="19"/>
                    <measurement group_id="O8" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA decline &gt;=3 log10 IU/mL</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="59"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="27"/>
                    <measurement group_id="O6" value="19"/>
                    <measurement group_id="O7" value="11"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Alanine Aminotransferase (ALT) Normalization</title>
        <description>The ALT normalization (ALT≤ upper limit of normal [ULN]) over time in absence of rescue medication in participants with baseline ALT&gt;ULN.&#xD;
Participants who achieved ALT normalization were reported.</description>
        <time_frame>At Baseline and Week 24</time_frame>
        <population>The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Alanine Aminotransferase (ALT) Normalization</title>
          <description>The ALT normalization (ALT≤ upper limit of normal [ULN]) over time in absence of rescue medication in participants with baseline ALT&gt;ULN.&#xD;
Participants who achieved ALT normalization were reported.</description>
          <population>The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with ALT &gt; ULN, at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="68"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="70"/>
                    <count group_id="O6" value="68"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="20"/>
                    <measurement group_id="O6" value="20"/>
                    <measurement group_id="O7" value="21"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with ALT normalization, at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="18"/>
                    <count group_id="O6" value="19"/>
                    <count group_id="O7" value="19"/>
                    <count group_id="O8" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="11"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to ALT Normalization</title>
        <description>Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT&gt;ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT &gt;ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively.</description>
        <time_frame>Baseline and up to Week 48</time_frame>
        <population>The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. Only those participants with baseline ALT&gt;ULN were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to ALT Normalization</title>
          <description>Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT&gt;ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT &gt;ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively.</description>
          <population>The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations. Only those participants with baseline ALT&gt;ULN were analyzed.</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="21"/>
                <count group_id="O8" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6" lower_limit="1.1" upper_limit="NA">Upper limit was Not estimable (NE) due to an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="4.1" lower_limit="1.0" upper_limit="11.9"/>
                    <measurement group_id="O3" value="1" lower_limit="1.0" upper_limit="8.1"/>
                    <measurement group_id="O4" value="7" lower_limit="1.1" upper_limit="NA">Upper limit was NE due to an insufficient number of participants.</measurement>
                    <measurement group_id="O5" value="13.4" lower_limit="2.1" upper_limit="NA">Upper limit was NE due to an insufficient number of participants with events</measurement>
                    <measurement group_id="O6" value="15.1" lower_limit="4.3" upper_limit="18.1"/>
                    <measurement group_id="O7" value="10.7" lower_limit="5.1" upper_limit="21.1"/>
                    <measurement group_id="O8" value="18.1" lower_limit="1" upper_limit="32.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb)</title>
        <description>Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb)</title>
          <description>Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported.</description>
          <population>The analysis was performed on the ITT Set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean HBsAg and HBV DNA Level</title>
        <description>Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points.</description>
        <time_frame>At Baseline, Week 12, and 24</time_frame>
        <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean HBsAg and HBV DNA Level</title>
          <description>Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points.</description>
          <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.</population>
          <units>Log10 (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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HBsAg, at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="70"/>
                    <count group_id="O6" value="68"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="0.623"/>
                    <measurement group_id="O2" value="3.26" spread="0.608"/>
                    <measurement group_id="O3" value="3.33" spread="0.588"/>
                    <measurement group_id="O4" value="3.43" spread="0.435"/>
                    <measurement group_id="O5" value="3.72" spread="0.771"/>
                    <measurement group_id="O6" value="3.64" spread="0.721"/>
                    <measurement group_id="O7" value="3.66" spread="0.675"/>
                    <measurement group_id="O8" value="3.76" spread="0.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg, at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="64"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="61"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="1.878"/>
                    <measurement group_id="O2" value="1.04" spread="1.858"/>
                    <measurement group_id="O3" value="1.76" spread="1.706"/>
                    <measurement group_id="O4" value="3.36" spread="0.431"/>
                    <measurement group_id="O5" value="1.39" spread="1.965"/>
                    <measurement group_id="O6" value="1.27" spread="2.000"/>
                    <measurement group_id="O7" value="1.57" spread="1.808"/>
                    <measurement group_id="O8" value="3.68" spread="0.798"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg, at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="1.939"/>
                    <measurement group_id="O2" value="1.45" spread="1.809"/>
                    <measurement group_id="O3" value="2.51" spread="1.536"/>
                    <measurement group_id="O4" value="0.83" spread="1.801"/>
                    <measurement group_id="O5" value="0.77" spread="2.016"/>
                    <measurement group_id="O6" value="1.88" spread="1.915"/>
                    <measurement group_id="O7" value="2.88" spread="1.511"/>
                    <measurement group_id="O8" value="1.64" spread="2.171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA, at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="70"/>
                    <count group_id="O6" value="67"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" spread="0.638"/>
                    <measurement group_id="O2" value="0.39" spread="0.603"/>
                    <measurement group_id="O3" value="0.53" spread="0.659"/>
                    <measurement group_id="O4" value="0.40" spread="0.622"/>
                    <measurement group_id="O5" value="5.02" spread="1.527"/>
                    <measurement group_id="O6" value="5.14" spread="1.557"/>
                    <measurement group_id="O7" value="4.67" spread="1.497"/>
                    <measurement group_id="O8" value="5.57" spread="1.654"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA, at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="64"/>
                    <count group_id="O6" value="62"/>
                    <count group_id="O7" value="60"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.74" spread="0.654"/>
                    <measurement group_id="O2" value="0.86" spread="0.700"/>
                    <measurement group_id="O3" value="0.67" spread="0.785"/>
                    <measurement group_id="O4" value="0.61" spread="0.682"/>
                    <measurement group_id="O5" value="3.00" spread="2.242"/>
                    <measurement group_id="O6" value="2.92" spread="2.142"/>
                    <measurement group_id="O7" value="2.68" spread="1.996"/>
                    <measurement group_id="O8" value="4.96" spread="2.074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA, at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="59"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" spread="0.654"/>
                    <measurement group_id="O2" value="0.56" spread="0.649"/>
                    <measurement group_id="O3" value="0.56" spread="0.714"/>
                    <measurement group_id="O4" value="0.79" spread="0.667"/>
                    <measurement group_id="O5" value="2.37" spread="2.137"/>
                    <measurement group_id="O6" value="2.93" spread="2.317"/>
                    <measurement group_id="O7" value="3.07" spread="1.938"/>
                    <measurement group_id="O8" value="3.04" spread="2.224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level</title>
        <description>Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).</description>
        <time_frame>At Baseline, Week 12, and 24</time_frame>
        <population>The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level</title>
          <description>Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).</description>
          <population>The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</population>
          <units>Log10 unit per milliliter (U/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="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="16"/>
                <count group_id="O8" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HBeAg, at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="1.014"/>
                    <measurement group_id="O2" value="0.12" spread="0.756"/>
                    <measurement group_id="O3" value="0.36" spread="1.053"/>
                    <measurement group_id="O4" value="0.63" spread="1.323"/>
                    <measurement group_id="O5" value="2.13" spread="1.564"/>
                    <measurement group_id="O6" value="2.52" spread="0.919"/>
                    <measurement group_id="O7" value="1.77" spread="1.612"/>
                    <measurement group_id="O8" value="2.84" spread="0.743"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBeAg, at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="19"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="1.027"/>
                    <measurement group_id="O2" value="-0.21" spread="0.732"/>
                    <measurement group_id="O3" value="0.19" spread="1.089"/>
                    <measurement group_id="O4" value="0.60" spread="1.310"/>
                    <measurement group_id="O5" value="1.84" spread="1.805"/>
                    <measurement group_id="O6" value="1.52" spread="1.831"/>
                    <measurement group_id="O7" value="1.07" spread="1.551"/>
                    <measurement group_id="O8" value="2.79" spread="0.725"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBeAg, at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="18"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.41" spread="0.635"/>
                    <measurement group_id="O2" value="-0.48" spread="0.752"/>
                    <measurement group_id="O3" value="-0.19" spread="1.071"/>
                    <measurement group_id="O4" value="0.08" spread="1.497"/>
                    <measurement group_id="O5" value="1.18" spread="2.064"/>
                    <measurement group_id="O6" value="1.34" spread="1.936"/>
                    <measurement group_id="O7" value="0.89" spread="1.667"/>
                    <measurement group_id="O8" value="1.06" spread="2.165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in HBsAg and HBV DNA Level</title>
        <description>Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL).</description>
        <time_frame>At Baseline, Week 12, and 24</time_frame>
        <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in HBsAg and HBV DNA Level</title>
          <description>Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL).</description>
          <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. One participant from 12+12 weeks not on NA therapy has no baseline data due to insufficient sample quantity at baseline.</population>
          <units>log 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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HBsAg, at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="70"/>
                    <count group_id="O6" value="68"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="0.623"/>
                    <measurement group_id="O2" value="3.26" spread="0.608"/>
                    <measurement group_id="O3" value="3.33" spread="0.588"/>
                    <measurement group_id="O4" value="3.43" spread="0.435"/>
                    <measurement group_id="O5" value="3.72" spread="0.771"/>
                    <measurement group_id="O6" value="3.64" spread="0.721"/>
                    <measurement group_id="O7" value="3.66" spread="0.675"/>
                    <measurement group_id="O8" value="3.76" spread="0.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg, at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="64"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="61"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.09" spread="1.649"/>
                    <measurement group_id="O2" value="-2.23" spread="1.597"/>
                    <measurement group_id="O3" value="-1.59" spread="1.474"/>
                    <measurement group_id="O4" value="-0.03" spread="0.089"/>
                    <measurement group_id="O5" value="-2.37" spread="1.585"/>
                    <measurement group_id="O6" value="-2.41" spread="1.562"/>
                    <measurement group_id="O7" value="-2.06" spread="1.638"/>
                    <measurement group_id="O8" value="-0.08" spread="0.292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBsAg, at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="63"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.62" spread="1.653"/>
                    <measurement group_id="O2" value="-1.81" spread="1.488"/>
                    <measurement group_id="O3" value="-0.83" spread="1.248"/>
                    <measurement group_id="O4" value="-2.57" spread="1.671"/>
                    <measurement group_id="O5" value="-2.96" spread="1.656"/>
                    <measurement group_id="O6" value="-1.77" spread="1.489"/>
                    <measurement group_id="O7" value="-0.77" spread="1.108"/>
                    <measurement group_id="O8" value="-2.09" spread="1.764"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA, at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="68"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="70"/>
                    <count group_id="O6" value="67"/>
                    <count group_id="O7" value="68"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="0.623"/>
                    <measurement group_id="O2" value="3.26" spread="0.608"/>
                    <measurement group_id="O3" value="3.33" spread="0.588"/>
                    <measurement group_id="O4" value="3.43" spread="0.435"/>
                    <measurement group_id="O5" value="3.72" spread="0.771"/>
                    <measurement group_id="O6" value="3.64" spread="0.721"/>
                    <measurement group_id="O7" value="3.66" spread="0.675"/>
                    <measurement group_id="O8" value="3.76" spread="0.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA, at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="63"/>
                    <count group_id="O3" value="61"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="64"/>
                    <count group_id="O6" value="61"/>
                    <count group_id="O7" value="60"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.24" spread="0.793"/>
                    <measurement group_id="O2" value="0.47" spread="0.773"/>
                    <measurement group_id="O3" value="0.16" spread="0.942"/>
                    <measurement group_id="O4" value="0.19" spread="0.727"/>
                    <measurement group_id="O5" value="-1.96" spread="1.365"/>
                    <measurement group_id="O6" value="-2.22" spread="1.592"/>
                    <measurement group_id="O7" value="-1.92" spread="1.349"/>
                    <measurement group_id="O8" value="-0.54" spread="1.421"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBV DNA, at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="60"/>
                    <count group_id="O3" value="60"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="59"/>
                    <count group_id="O6" value="62"/>
                    <count group_id="O7" value="58"/>
                    <count group_id="O8" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" spread="0.831"/>
                    <measurement group_id="O2" value="0.17" spread="0.661"/>
                    <measurement group_id="O3" value="0.09" spread="0.928"/>
                    <measurement group_id="O4" value="0.33" spread="0.928"/>
                    <measurement group_id="O5" value="-2.66" spread="1.646"/>
                    <measurement group_id="O6" value="-2.2" spread="1.68"/>
                    <measurement group_id="O7" value="-1.52" spread="1.637"/>
                    <measurement group_id="O8" value="-2.6" spread="2.001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in HBeAg Level</title>
        <description>Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).</description>
        <time_frame>At Baseline, Week 12, and 24</time_frame>
        <population>The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in HBeAg Level</title>
          <description>Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).</description>
          <population>The analysis was performed on the ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment the participant was randomized to. The analysis was conducted separately for the on NA treatment and not currently on NA treatment populations.</population>
          <units>Log u/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="18"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="16"/>
                <count group_id="O7" value="16"/>
                <count group_id="O8" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HBeAg, at Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="16"/>
                    <count group_id="O8" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" spread="1.014"/>
                    <measurement group_id="O2" value="0.12" spread="0.756"/>
                    <measurement group_id="O3" value="0.36" spread="1.053"/>
                    <measurement group_id="O4" value="0.63" spread="1.323"/>
                    <measurement group_id="O5" value="2.13" spread="1.564"/>
                    <measurement group_id="O6" value="2.52" spread="0.919"/>
                    <measurement group_id="O7" value="1.77" spread="1.612"/>
                    <measurement group_id="O8" value="2.84" spread="0.743"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBeAg, at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="18"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.52" spread="0.874"/>
                    <measurement group_id="O2" value="-0.42" spread="0.480"/>
                    <measurement group_id="O3" value="-0.33" spread="0.343"/>
                    <measurement group_id="O4" value="-0.17" spread="0.453"/>
                    <measurement group_id="O5" value="-0.65" spread="0.919"/>
                    <measurement group_id="O6" value="-1.25" spread="1.522"/>
                    <measurement group_id="O7" value="-0.94" spread="1.618"/>
                    <measurement group_id="O8" value="-0.14" spread="0.313"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBeAg, at WeeK 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="18"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.85" spread="1.071"/>
                    <measurement group_id="O2" value="-0.56" spread="0.811"/>
                    <measurement group_id="O3" value="-0.46" spread="0.595"/>
                    <measurement group_id="O4" value="-0.56" spread="0.598"/>
                    <measurement group_id="O5" value="-1.01" spread="1.426"/>
                    <measurement group_id="O6" value="-1.18" spread="1.532"/>
                    <measurement group_id="O7" value="-0.70" spread="1.673"/>
                    <measurement group_id="O8" value="-1.78" spread="2.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level</title>
        <description>Blood samples were collected to assess anti-HBsAg level at indicated timepoints.</description>
        <time_frame>At Baseline, Week 36, and 48</time_frame>
        <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level</title>
          <description>Blood samples were collected to assess anti-HBsAg level at indicated timepoints.</description>
          <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data.</population>
          <units>Log10 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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="67"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="69"/>
                    <count group_id="O6" value="67"/>
                    <count group_id="O7" value="67"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="0.289"/>
                    <measurement group_id="O2" value="0.65" spread="0.165"/>
                    <measurement group_id="O3" value="0.64" spread="0.129"/>
                    <measurement group_id="O4" value="0.66" spread="0.287"/>
                    <measurement group_id="O5" value="0.65" spread="0.284"/>
                    <measurement group_id="O6" value="0.69" spread="0.303"/>
                    <measurement group_id="O7" value="0.62" spread="0.150"/>
                    <measurement group_id="O8" value="0.74" spread="0.307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="66"/>
                    <count group_id="O7" value="61"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.94" spread="0.534"/>
                    <measurement group_id="O2" value="0.83" spread="0.401"/>
                    <measurement group_id="O3" value="0.74" spread="0.333"/>
                    <measurement group_id="O4" value="0.79" spread="0.368"/>
                    <measurement group_id="O5" value="1.01" spread="0.660"/>
                    <measurement group_id="O6" value="0.82" spread="0.385"/>
                    <measurement group_id="O7" value="0.74" spread="0.347"/>
                    <measurement group_id="O8" value="0.90" spread="0.437"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 48</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="66"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="62"/>
                    <count group_id="O6" value="65"/>
                    <count group_id="O7" value="63"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.88" spread="0.471"/>
                    <measurement group_id="O2" value="0.77" spread="0.368"/>
                    <measurement group_id="O3" value="0.70" spread="0.277"/>
                    <measurement group_id="O4" value="0.75" spread="0.326"/>
                    <measurement group_id="O5" value="0.91" spread="0.567"/>
                    <measurement group_id="O6" value="0.79" spread="0.369"/>
                    <measurement group_id="O7" value="0.71" spread="0.296"/>
                    <measurement group_id="O8" value="0.83" spread="0.356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Anti-HBsAg Level</title>
        <description>Blood samples were collected to assess anti-HBsAg level at indicated timepoints.</description>
        <time_frame>At Baseline, Week 12, and 24</time_frame>
        <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O5">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O6">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O7">
            <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
          </group>
          <group group_id="O8">
            <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Anti-HBsAg Level</title>
          <description>Blood samples were collected to assess anti-HBsAg level at indicated timepoints.</description>
          <population>The analysis was performed on ITT set that includes all randomized participants who received a treatment randomization number. This population was based on the treatment participant was randomized to. One participant from 12+12 weeks on NA therapy arm who was randomized in error is in ITT population but did not contribute any lab data so is not part of the analysis. Four participants across other arms had missing anti-HBsAg baseline data.</population>
          <units>Log10 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="68"/>
                <count group_id="O2" value="68"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="23"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
                <count group_id="O7" value="68"/>
                <count group_id="O8" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="68"/>
                    <count group_id="O2" value="67"/>
                    <count group_id="O3" value="67"/>
                    <count group_id="O4" value="23"/>
                    <count group_id="O5" value="69"/>
                    <count group_id="O6" value="67"/>
                    <count group_id="O7" value="67"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.67" spread="0.289"/>
                    <measurement group_id="O2" value="0.65" spread="0.165"/>
                    <measurement group_id="O3" value="0.64" spread="0.129"/>
                    <measurement group_id="O4" value="0.66" spread="0.287"/>
                    <measurement group_id="O5" value="0.65" spread="0.284"/>
                    <measurement group_id="O6" value="0.69" spread="0.303"/>
                    <measurement group_id="O7" value="0.62" spread="0.150"/>
                    <measurement group_id="O8" value="0.74" spread="0.307"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="64"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="63"/>
                    <count group_id="O6" value="66"/>
                    <count group_id="O7" value="60"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.28" spread="0.481"/>
                    <measurement group_id="O2" value="0.18" spread="0.343"/>
                    <measurement group_id="O3" value="0.11" spread="0.319"/>
                    <measurement group_id="O4" value="0.13" spread="0.250"/>
                    <measurement group_id="O5" value="0.37" spread="0.615"/>
                    <measurement group_id="O6" value="0.13" spread="0.353"/>
                    <measurement group_id="O7" value="0.12" spread="0.221"/>
                    <measurement group_id="O8" value="0.16" spread="0.355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="65"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="22"/>
                    <count group_id="O5" value="62"/>
                    <count group_id="O6" value="65"/>
                    <count group_id="O7" value="62"/>
                    <count group_id="O8" value="24"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.22" spread="0.429"/>
                    <measurement group_id="O2" value="0.12" spread="0.335"/>
                    <measurement group_id="O3" value="0.07" spread="0.267"/>
                    <measurement group_id="O4" value="0.09" spread="0.239"/>
                    <measurement group_id="O5" value="0.26" spread="0.507"/>
                    <measurement group_id="O6" value="0.10" spread="0.319"/>
                    <measurement group_id="O7" value="0.09" spread="0.203"/>
                    <measurement group_id="O8" value="0.09" spread="0.203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836</title>
        <description>Intensive pharmacokinetic (PK) sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h of GSK3228836.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 Dose Level 150mg</title>
            <description>Represents Pharmacokinetic (PK) set of participants who received GSK3228836 at a dose level of 150 mg once a week.</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 Dose Level 300mg</title>
            <description>Represents Pharmacokinetic (PK) set of participants who received GSK3228836 at a dose level of 300 mg once a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836</title>
          <description>Intensive pharmacokinetic (PK) sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h of GSK3228836.</description>
          <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>hour*micrograms per milliliter (h*ug/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="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.214" spread="22.9901"/>
                    <measurement group_id="O2" value="140.312" spread="37.3548"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Maximum Observed Concentration (Cmax) of GSK3228836</title>
        <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax of GSK3228836.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 Dose Level 150mg</title>
            <description>Represents PK set of participants who received GSK3228836 at a dose level of 150 mg once a week.</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 Dose Level 300mg</title>
            <description>Represents PK set of participants who received GSK3228836 at a dose level of 300 mg once a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Maximum Observed Concentration (Cmax) of GSK3228836</title>
          <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax of GSK3228836.</description>
          <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>ug/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="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.112" spread="2.8112"/>
                    <measurement group_id="O2" value="14.956" spread="5.6592"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time of Maximum Observed Concentration (Tmax) of GSK3228836</title>
        <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax of GSK3228836.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 Dose Level 150mg</title>
            <description>Represents PK set of participants who received GSK3228836 at a dose level of 150 mg once a week.</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 Dose Level 300mg</title>
            <description>Represents PK set of participants who received GSK3228836 at a dose level of 300 mg once a week.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time of Maximum Observed Concentration (Tmax) of GSK3228836</title>
          <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax of GSK3228836.</description>
          <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.008" lower_limit="2.00" upper_limit="4.02"/>
                    <measurement group_id="O2" value="3.017" lower_limit="2.00" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean AUC0-24h of NA Therapies</title>
        <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate</title>
            <description>Participants who received Tenofovir disoproxil fumarate 245 or 300 mg once daily.</description>
          </group>
          <group group_id="O2">
            <title>Tenofovir Alafenamide</title>
            <description>Participants who received Tenofovir alafenamide 25 mg once daily or every 2 days.</description>
          </group>
          <group group_id="O3">
            <title>Entecavir</title>
            <description>Participants who received Entecavir 0.5 mg once a daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean AUC0-24h of NA Therapies</title>
          <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
          <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>h*nanograms per milliliter (h*ng/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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2753.908" spread="661.3392"/>
                    <measurement group_id="O2" value="308.167" spread="104.8297"/>
                    <measurement group_id="O3" value="24.43" spread="6.761"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Ctau of NA Therapies</title>
        <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Ctau. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate</title>
            <description>Participants who received Tenofovir disoproxil fumarate 245 or 300 mg once daily.</description>
          </group>
          <group group_id="O2">
            <title>Tenofovir Alafenamide</title>
            <description>Participants who received Tenofovir alafenamide 25 mg once daily or every 2 days.</description>
          </group>
          <group group_id="O3">
            <title>Entecavir</title>
            <description>Participants who received Entecavir 0.5 mg once a daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Ctau of NA Therapies</title>
          <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Ctau. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
          <population>The analysis was performed on the PK Set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>ng/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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.04" spread="17.0787"/>
                    <measurement group_id="O2" value="10.31" spread="3.4802"/>
                    <measurement group_id="O3" value="0.478" spread="0.1055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Cmax of NA Therapies</title>
        <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate</title>
            <description>Participants who received Tenofovir disoproxil fumarate 245 or 300 mg once daily.</description>
          </group>
          <group group_id="O2">
            <title>Tenofovir Alafenamide</title>
            <description>Participants who received Tenofovir alafenamide 25 mg once daily or every 2 days.</description>
          </group>
          <group group_id="O3">
            <title>Entecavir</title>
            <description>Participants who received Entecavir in 0.5 mg once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Cmax of NA Therapies</title>
          <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
          <population>The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>ng/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="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="318.857" spread="95.94"/>
                    <measurement group_id="O2" value="19.36" spread="5.85"/>
                    <measurement group_id="O3" value="6.526" spread="2.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Tmax of NA Therapies</title>
        <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>Tenofovir Disoproxil Fumarate</title>
            <description>Participants who received Tenofovir disoproxil fumarate 245 or 300 mg once daily.</description>
          </group>
          <group group_id="O2">
            <title>Tenofovir Alafenamide</title>
            <description>Participants who received Tenofovir alafenamide 25 mg once daily or every 2 days.</description>
          </group>
          <group group_id="O3">
            <title>Entecavir</title>
            <description>Participants who received Entecavir 0.5 mg once a daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Tmax of NA Therapies</title>
          <description>Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.</description>
          <population>The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0.52" upper_limit="1.47"/>
                    <measurement group_id="O2" value="1.417" lower_limit="0.93" upper_limit="1.55"/>
                    <measurement group_id="O3" value="0.983" lower_limit="0.48" upper_limit="2.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Terminal Half-life (t1/2) of GSK3228836</title>
        <description>Blood samples were collected from all participants for t1/2 analysis of GSK3228836. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.</description>
        <time_frame>Up to Week 48</time_frame>
        <population>The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O4">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Terminal Half-life (t1/2) of GSK3228836</title>
          <description>Blood samples were collected from all participants for t1/2 analysis of GSK3228836. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.</description>
          <population>The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>Day</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.897" lower_limit="7.52" upper_limit="191.98"/>
                    <measurement group_id="O2" value="24.918" lower_limit="8.84" upper_limit="216.43"/>
                    <measurement group_id="O3" value="27.846" lower_limit="10.19" upper_limit="149.74"/>
                    <measurement group_id="O4" value="38.205" lower_limit="6.87" upper_limit="161.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Ctau of GSK3228836</title>
        <description>Blood samples were collected from all participants for Ctau analysis of GSK3228836 at indicated. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
        <group_list>
          <group group_id="O1">
            <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
            <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O2">
            <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
          <group group_id="O3">
            <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
          </group>
          <group group_id="O4">
            <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
            <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Ctau of GSK3228836</title>
          <description>Blood samples were collected from all participants for Ctau analysis of GSK3228836 at indicated. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.</description>
          <population>The analysis was performed on the PK set that includes all participants in the Safety population who received an active study treatment and had at least 1 non-missing PK assessment (NQ values were considered as non-missing values).</population>
          <units>ng/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="68"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="62"/>
                    <count group_id="O2" value="62"/>
                    <count group_id="O3" value="67"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.009" spread="9.6214"/>
                    <measurement group_id="O2" value="47.039" spread="198.1345"/>
                    <measurement group_id="O3" value="21.663" spread="14.4479"/>
                    <measurement group_id="O4" value="23.46" spread="16.6498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="64"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.162" spread="11.8963"/>
                    <measurement group_id="O2" value="23.234" spread="11.6993"/>
                    <measurement group_id="O3" value="21.777" spread="9.9248"/>
                    <measurement group_id="O4" value="22.789" spread="11.7361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="61"/>
                    <count group_id="O3" value="63"/>
                    <count group_id="O4" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.102" spread="28.7535"/>
                    <measurement group_id="O2" value="18.95" spread="14.6513"/>
                    <measurement group_id="O3" value="28.158" spread="17.0606"/>
                    <measurement group_id="O4" value="20.138" spread="19.023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events (AEs) and serious adverse events (SAEs) were collected from the signing of the informed consent until the final follow-up visit, up to 48 weeks.</time_frame>
      <desc>The safety population included participants who received at least one dose of study treatment.&#xD;
The safety population was comprised of 455 participants, 2 participants excluded from arms GSK3228836 300mg for 12 weeks in both on NA and not on NA therapy population, respectively. Both participants did not receive study treatment, one due to randomization error (on NA therapy) and other due to the participant decision due to concern of potential side effects (not on NA therapy).</desc>
      <group_list>
        <group group_id="E1">
          <title>GSK3228836 for 24 Weeks (WK) (on NA Therapy)</title>
          <description>All participants of this arm received 300 milligram (mg) GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
        </group>
        <group group_id="E2">
          <title>GSK3228836 for 12+12 WK (on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="E3">
          <title>GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)</title>
          <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="E5">
          <title>GSK3228836 for 24 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 24 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11).</description>
        </group>
        <group group_id="E6">
          <title>GSK3228836 for 12+12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by step-down in dose of 150 mg (plus placebo to match to maintain participant blinding) GSK3228836 once/week for 12 weeks.</description>
        </group>
        <group group_id="E7">
          <title>GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received 300 mg GSK3228836 once/week for 12 weeks (plus a loading dose of 300 mg GSK3228836 on Day 4 and 11) followed by placebo once/week for 12 weeks.</description>
        </group>
        <group group_id="E8">
          <title>Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)</title>
          <description>All participants of this arm received Placebo once/week for 12 weeks (plus placebo loading doses to match on Day 4 and 11) followed by 300 mg GSK3228836 once/week for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>v24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="70"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscle injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Spinal column injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bile duct cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical dysplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Cryoglobulinaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>v24.1</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="56" subjects_at_risk="68"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="53" subjects_at_risk="68"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="23"/>
                <counts group_id="E5" subjects_affected="65" subjects_at_risk="70"/>
                <counts group_id="E6" subjects_affected="60" subjects_at_risk="67"/>
                <counts group_id="E7" subjects_affected="61" subjects_at_risk="68"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal clotting factor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Monocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Polycythaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="9" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="5" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Dyschromatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Deafness neurosensory</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Meniere's disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Noninfective conjunctivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Periorbital swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E6" events="5" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Abdominal tenderness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Change of bowel habit</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gastrointestinal sounds abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gingival ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oesophageal spasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tooth disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="11" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Energy increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E3" events="13" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="19" subjects_affected="13" subjects_at_risk="70"/>
                <counts group_id="E6" events="15" subjects_affected="7" subjects_at_risk="67"/>
                <counts group_id="E7" events="11" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site anaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="36" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="67"/>
                <counts group_id="E3" events="23" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E4" events="13" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E5" events="42" subjects_affected="13" subjects_at_risk="70"/>
                <counts group_id="E6" events="29" subjects_affected="10" subjects_at_risk="67"/>
                <counts group_id="E7" events="33" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E8" events="10" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site discolouration</sub_title>
                <counts group_id="E1" events="22" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E2" events="65" subjects_affected="9" subjects_at_risk="67"/>
                <counts group_id="E3" events="92" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E5" events="39" subjects_affected="13" subjects_at_risk="70"/>
                <counts group_id="E6" events="46" subjects_affected="11" subjects_at_risk="67"/>
                <counts group_id="E7" events="37" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E8" events="4" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site discomfort</sub_title>
                <counts group_id="E1" events="13" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="62" subjects_affected="9" subjects_at_risk="67"/>
                <counts group_id="E3" events="54" subjects_affected="9" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="13" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E6" events="25" subjects_affected="6" subjects_at_risk="67"/>
                <counts group_id="E7" events="25" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site erosion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="216" subjects_affected="36" subjects_at_risk="68"/>
                <counts group_id="E2" events="175" subjects_affected="37" subjects_at_risk="67"/>
                <counts group_id="E3" events="194" subjects_affected="34" subjects_at_risk="68"/>
                <counts group_id="E4" events="22" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E5" events="264" subjects_affected="34" subjects_at_risk="70"/>
                <counts group_id="E6" events="150" subjects_affected="30" subjects_at_risk="67"/>
                <counts group_id="E7" events="179" subjects_affected="37" subjects_at_risk="68"/>
                <counts group_id="E8" events="23" subjects_affected="10" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" events="15" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="17" subjects_affected="8" subjects_at_risk="70"/>
                <counts group_id="E6" events="12" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" events="14" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E3" events="13" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="20" subjects_affected="6" subjects_at_risk="70"/>
                <counts group_id="E6" events="16" subjects_affected="7" subjects_at_risk="67"/>
                <counts group_id="E7" events="5" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site nodule</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="4" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="45" subjects_affected="11" subjects_at_risk="68"/>
                <counts group_id="E2" events="59" subjects_affected="15" subjects_at_risk="67"/>
                <counts group_id="E3" events="118" subjects_affected="21" subjects_at_risk="68"/>
                <counts group_id="E4" events="16" subjects_affected="6" subjects_at_risk="23"/>
                <counts group_id="E5" events="198" subjects_affected="20" subjects_at_risk="70"/>
                <counts group_id="E6" events="61" subjects_affected="13" subjects_at_risk="67"/>
                <counts group_id="E7" events="66" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E8" events="41" subjects_affected="6" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="88" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E2" events="78" subjects_affected="17" subjects_at_risk="67"/>
                <counts group_id="E3" events="100" subjects_affected="15" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E5" events="198" subjects_affected="23" subjects_at_risk="70"/>
                <counts group_id="E6" events="85" subjects_affected="16" subjects_at_risk="67"/>
                <counts group_id="E7" events="98" subjects_affected="19" subjects_at_risk="68"/>
                <counts group_id="E8" events="4" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="45" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" events="12" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E3" events="70" subjects_affected="13" subjects_at_risk="68"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="69" subjects_affected="10" subjects_at_risk="70"/>
                <counts group_id="E6" events="44" subjects_affected="7" subjects_at_risk="67"/>
                <counts group_id="E7" events="13" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site warmth</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="13" subjects_affected="5" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="39" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="34" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="19" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="10" subjects_at_risk="68"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="67"/>
                <counts group_id="E3" events="19" subjects_affected="10" subjects_at_risk="68"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="23"/>
                <counts group_id="E5" events="23" subjects_affected="15" subjects_at_risk="70"/>
                <counts group_id="E6" events="38" subjects_affected="17" subjects_at_risk="67"/>
                <counts group_id="E7" events="23" subjects_affected="17" subjects_at_risk="68"/>
                <counts group_id="E8" events="5" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Scar inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaccination site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Gallbladder polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatic cytolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Immunodeficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Type III immune complex mediated reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Asymptomatic bacteriuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Bacteriuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="67"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="67"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Chronic hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Helicobacter gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Herpes dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injection site cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="6" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Parotitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pustule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Suspected COVID-19</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaginitis gardnerella</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </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" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Back injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Eye injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nail injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Post vaccination syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tooth avulsion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tooth dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tooth injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaccination complication</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="13" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="67"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E5" events="25" subjects_affected="17" subjects_at_risk="70"/>
                <counts group_id="E6" events="18" subjects_affected="15" subjects_at_risk="67"/>
                <counts group_id="E7" events="21" subjects_affected="12" subjects_at_risk="68"/>
                <counts group_id="E8" events="9" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Albumin urine present</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Antineutrophil cytoplasmic antibody positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Antinuclear antibody positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E5" events="11" subjects_affected="8" subjects_at_risk="70"/>
                <counts group_id="E6" events="12" subjects_affected="9" subjects_at_risk="67"/>
                <counts group_id="E7" events="9" subjects_affected="7" subjects_at_risk="68"/>
                <counts group_id="E8" events="4" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Autoantibody positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Bilirubin conjugated increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood calcium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood creatine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="7" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Complement factor C3 decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="70"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Complement factor C4 decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Complement factor abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Complement factor increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="21" subjects_affected="6" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="10" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Creatinine urine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Crystal urine present</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hepatitis B DNA assay positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Immature granulocyte count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Mean cell volume decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="11" subjects_affected="8" subjects_at_risk="70"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Prothrombin time prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Red blood cells urine positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Total complement activity decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urinary sediment present</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urine albumin/creatinine ratio</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urine albumin/creatinine ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urine analysis abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urine leukocyte esterase positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cell death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="15" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vitamin B complex deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="5" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="67"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E7" events="5" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Bone swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="12" subjects_affected="10" subjects_at_risk="70"/>
                <counts group_id="E6" events="10" subjects_affected="7" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="3" subjects_affected="3" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E6" events="6" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sacral pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cervix carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemangioma of liver</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ageusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="6" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="10" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="67"/>
                <counts group_id="E3" events="15" subjects_affected="8" subjects_at_risk="68"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="23"/>
                <counts group_id="E5" events="25" subjects_affected="14" subjects_at_risk="70"/>
                <counts group_id="E6" events="50" subjects_affected="14" subjects_at_risk="67"/>
                <counts group_id="E7" events="26" subjects_affected="14" subjects_at_risk="68"/>
                <counts group_id="E8" events="4" subjects_affected="4" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Stress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Albuminuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cylindruria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Glycosuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ketonuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Leukocyturia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nephrocalcinosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nephropathy toxic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="4" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urine abnormality</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Adenomyosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cervical polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cervix haemorrhage uterine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Genital haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Menstrual disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vulvovaginal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vulvovaginal swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Catarrh</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperventilation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nasal pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Reflux laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Asteatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Blood blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Drug reaction with eosinophilia and systemic symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E7" events="6" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Haemorrhage subcutaneous</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hand dermatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Nail bed bleeding</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E6" events="12" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E7" events="7" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="8" subjects_affected="4" subjects_at_risk="68"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="11" subjects_affected="7" subjects_at_risk="67"/>
                <counts group_id="E7" events="13" subjects_affected="5" subjects_at_risk="68"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Skin plaque</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Umbilical erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="4" subjects_affected="3" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Urticarial vasculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="70"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vascular pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="68"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="24"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>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/NCT04449029
org study id: 209668
nct id: NCT04449029
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem.
      GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and
      in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if
      treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B
      virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV
      deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In
      addition, the study will also evaluate the safety, tolerability, pharmacokinetic and
      pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the
      efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB;
      participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not
      currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be
      randomized into one of the 4 different parallel arms to receive treatment. The study will
      consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440
      participants will be enrolled in the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants with CHB will be divided into two different cohorts; participants on stable nucleos(t)ide treatment and participants not currently on nucleos(t)ide therapy. For each cohort, participants will be randomized into one of the 4 different parallel arms to receive treatment.
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants will be blinded to the study treatment.
measure: Number of Participants Achieving Sustained Virologic Response (SVR)
time frame: Up to Week 48
description: The SVR was a composite endpoint defined as Hepatitis B surface antigen (HBsAg) and Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) levels were less than (<) Lower limit of quantitation (LLOQ) at the planned end of GSK3228836 treatment which is sustained for 24 weeks post-GSK3228836 treatment in the absence of rescue medication.
measure: Number of Participants Achieving HBsAg and HBV DNA<LLOQ
time frame: Up to Week 26
description: Participants achieving HBsAg and HBV DNA levels <LLOQ at the end of treatment (EOT) were reported.
measure: Number of Participants With Categorical Changes From Baseline in HBsAg Values
time frame: At Baseline and Week 24
description: Participants who achieved a decline in HBsAg values from baseline were reported. Participants were categorized in the following categorical HBsAg decline of <0.5, greater than or equal to (>=) 0.5, >=1, >=1.5, and >=3 log10 international units per milliliter (IU/mL).
measure: Number of Participants With Categorical Changes From Baseline in HBV DNA Values
time frame: At Baseline and Week 24
description: Participants who achieved a decline in HBV DNA values from baseline were reported. Participants were categorized in the following categorical HBV DNA decline of <1, >=1, >=2, and >=3 log IU/mL.
measure: Number of Participants With Alanine Aminotransferase (ALT) Normalization
time frame: At Baseline and Week 24
description: The ALT normalization (ALT≤ upper limit of normal [ULN]) over time in absence of rescue medication in participants with baseline ALT>ULN.
Participants who achieved ALT normalization were reported.
measure: Median Time to ALT Normalization
time frame: Baseline and up to Week 48
description: Time to ALT normalization (ALT≤ULN) in the absence of rescue medication in participants with baseline ALT>ULN. Numbers of participants analyzed at Week 24 include participants with baseline ALT >ULN, and are as follows for NA therapy population: n=6 in GSK3228836 for 24 WK, n= 7 in GSK3228836 for 12 WK+12 WK, n=6 in GSK3228836 for 12 WK + Placebo for 12 WK, n=2 in Placebo for 12 WK + GSK3228836 for 12 WK, respectively. The numbers of participants analyzed are as follows for the not on NA therapy population: n=20 GSK3228836 for 24 WK, n=20 in GSK3228836 for 12 WK+12 WK, n=21 in GSK3228836 for 12 WK + Placebo for 12 WK, n=9 in Placebo for 12 WK + GSK3228836 for 12 WK arm, respectively.
measure: Number of Participants With Positive Hepatitis B Virus E-antibody (HBeAb)
time frame: Up to Week 48
description: Blood samples were collected to assess HBeAb level and participants with positive HBeAb were reported.
measure: Mean HBsAg and HBV DNA Level
time frame: At Baseline, Week 12, and 24
description: Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points.
measure: Mean Values of Hepatitis B Virus e Antigen (HBeAg) Level
time frame: At Baseline, Week 12, and 24
description: Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).
measure: Mean Change From Baseline in HBsAg and HBV DNA Level
time frame: At Baseline, Week 12, and 24
description: Blood samples were collected from participants to assess HBsAg and HBV DNA level at indicated time points. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 IU/mL = -0.03 log10 IU/mL).
measure: Mean Change From Baseline in HBeAg Level
time frame: At Baseline, Week 12, and 24
description: Blood samples were collected from participants to assess HBeAg level at indicated time points. Participants with presence of HBeAg at baseline were analyzed at indicated timepoint. Note: The units are on the log10 scale so negative values are expected (e.g. 0.933 U/mL = -0.03 log10 U/mL).
measure: Mean Hepatitis B Virus Surface Antigen Antibody (Anti-HBsAg) Level
time frame: At Baseline, Week 36, and 48
description: Blood samples were collected to assess anti-HBsAg level at indicated timepoints.
measure: Mean Change From Baseline in Anti-HBsAg Level
time frame: At Baseline, Week 12, and 24
description: Blood samples were collected to assess anti-HBsAg level at indicated timepoints.
measure: Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836
time frame: Up to Week 24
description: Intensive pharmacokinetic (PK) sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h of GSK3228836.
measure: Mean Maximum Observed Concentration (Cmax) of GSK3228836
time frame: Up to Week 24
description: Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax of GSK3228836.
measure: Median Time of Maximum Observed Concentration (Tmax) of GSK3228836
time frame: Up to Week 24
description: Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax of GSK3228836.
measure: Mean AUC0-24h of NA Therapies
time frame: Up to Week 24
description: Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze AUC0-24h. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
measure: Mean Ctau of NA Therapies
time frame: Up to Week 24
description: Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Ctau. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
measure: Mean Cmax of NA Therapies
time frame: Up to Week 24
description: Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze Cmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
measure: Median Tmax of NA Therapies
time frame: Up to Week 24
description: Intensive PK sampling was done in a subset of participants on stable NA therapy to analyze tmax. Participants on NA therapy were stratified as per the following NA therapy Tenofovir disoproxil fumarate 245 or 300 mg once daily, Tenofovir alafenamide 25 mg once a daily or every 2 days, and Entecavir 0.5 mg once daily.
measure: Median Terminal Half-life (t1/2) of GSK3228836
time frame: Up to Week 48
description: Blood samples were collected from all participants for t1/2 analysis of GSK3228836. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.
measure: Mean Ctau of GSK3228836
time frame: Up to Week 24
description: Blood samples were collected from all participants for Ctau analysis of GSK3228836 at indicated. Note: for this endpoint data for more comparable arms GSK3228836 for 24WK and 12+12 WK from both on NA and not on NA therapy were presented.
arm group label: Cohort 1: GSK3228836 300 mg + LD
arm group type: Experimental
description: Eligible participants on stable nucleos(t)ide treatment will receive 300 milligrams (mg) GSK3228836 once weekly for 24 weeks along with loading dose (LD) of 300 mg GSK3228836 on Day 4 and Day 11.
arm group label: Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo
arm group type: Experimental
description: Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.
arm group label: Cohort 1: GSK3228836 300 mg + LD/ Placebo
arm group type: Experimental
description: Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.
arm group label: Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD
arm group type: Experimental
description: Eligible participants on stable nucleos(t)ide treatment will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.
arm group label: Cohort 2: GSK3228836 300 mg + LD
arm group type: Experimental
description: Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 24 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11.
arm group label: Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo
arm group type: Experimental
description: Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.
arm group label: Cohort 2: GSK3228836 300 mg + LD/ Placebo
arm group type: Experimental
description: Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.
arm group label: Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD
arm group type: Experimental
description: Eligible participants not currently on nucleos(t)ide therapy will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.
intervention type: Drug
intervention name: GSK3228836
description: GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.
arm group label: Cohort 1: GSK3228836 300 mg + LD
arm group label: Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo
arm group label: Cohort 1: GSK3228836 300 mg + LD/ Placebo
arm group label: Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD
arm group label: Cohort 2: GSK3228836 300 mg + LD
arm group label: Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo
arm group label: Cohort 2: GSK3228836 300 mg + LD/ Placebo
arm group label: Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD
intervention type: Drug
intervention name: Placebo
description: Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.
arm group label: Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo
arm group label: Cohort 1: GSK3228836 300 mg + LD/ Placebo
arm group label: Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD
arm group label: Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo
arm group label: Cohort 2: GSK3228836 300 mg + LD/ Placebo
arm group label: Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LD
intervention type: Drug
intervention name: Nucleos(t)ide therapy
description: Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.
arm group label: Cohort 1: GSK3228836 300 mg + LD
arm group label: Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + Placebo
arm group label: Cohort 1: GSK3228836 300 mg + LD/ Placebo
arm group label: Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Argentina
country: Bulgaria
country: Canada
country: China
country: France
country: Germany
country: Hong Kong
country: Italy
country: Japan
country: Korea, Republic of
country: Malaysia
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: Singapore
country: South Africa
country: Spain
country: Taiwan
country: Thailand
country: United Kingdom
country: United States
citation: Yuen MF, Lim SG, Plesniak R, Tsuji K, Janssen HLA, Pojoga C, Gadano A, Popescu CP, Stepanova T, Asselah T, Diaconescu G, Yim HJ, Heo J, Janczewska E, Wong A, Idriz N, Imamura M, Rizzardini G, Takaguchi K, Andreone P, Arbune M, Hou J, Park SJ, Vata A, Cremer J, Elston R, Lukic T, Quinn G, Maynard L, Kendrick S, Plein H, Campbell F, Paff M, Theodore D; B-Clear Study Group. Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection. N Engl J Med. 2022 Nov 24;387(21):1957-1968. doi: 10.1056/NEJMoa2210027. Epub 2022 Nov 8.
PMID: 36346079
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
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