<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/NCT01706198</url>
  </required_header>
  <id_info>
    <org_study_id>115150</org_study_id>
    <nct_id>NCT01706198</nct_id>
  </id_info>
  <brief_title>An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma</brief_title>
  <official_title>A 12-month, Open Label, Randomised, Effectiveness Study to Evaluate Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler Compared With Usual Maintenance Therapy in Subjects With Asthma</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to compare the effectiveness and safety of Fluticasone&#xD;
      Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg&#xD;
      Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol&#xD;
      ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with&#xD;
      the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma.&#xD;
      This is a Phase III multi-centre, randomised open label study. Subjects who meet the&#xD;
      eligibility criteria are randomised and will enter a 12 month treatment period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase III multi-centre, randomised open label study performed in subjects followed&#xD;
      in primary care who have a diagnosis of and receive regular treatment for asthma in a&#xD;
      localised geographical region of the UK&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2012</start_date>
  <completion_date type="Actual">December 16, 2016</completion_date>
  <primary_completion_date type="Actual">December 1, 2016</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of &gt;=20 or an Increase From Baseline of &gt;=3 in ACT Total Score at Week 24.</measure>
    <time_frame>Baseline (Day 0) and Week 24</time_frame>
    <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of &lt;20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score &gt;=20 or an increase from Baseline of &gt;=3 has been presented</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Have Either an ACT Total Score of &gt;=20 or an Increase From Baseline of &gt;=3 in ACT Total Score at Weeks 12, 40 and 52.</measure>
    <time_frame>Baseline (Day 0) and Weeks 12, 40 and 52</time_frame>
    <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score &gt;=20 or an increase from Baseline of &gt;=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Asthma Control (ACT Total Score &gt;=20) at Weeks 12, 24, 40 and 52.</measure>
    <time_frame>Weeks 12, 24, 40 and 52</time_frame>
    <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score &gt;=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Have an Increase From Baseline of &gt;=3 in ACT Total Score at Weeks 12, 24, 40 and 52.</measure>
    <time_frame>Baseline (Day 0) and Weeks 12, 24, 40 and 52</time_frame>
    <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score &gt;=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.</measure>
    <time_frame>Baseline (Day 0) and Weeks 12, 24, 40 and 52</time_frame>
    <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Each ACT Total Score Category (&gt;=20, 16 to 19, &lt;=15) at Weeks 12, 24, 40 and 52.</measure>
    <time_frame>Weeks 12, 24, 40 and 52</time_frame>
    <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is &gt;=20, 16 to 19 and &lt;=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Rate of Asthma-related Secondary Care Contacts</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A&amp;E) contact. A participant with an A&amp;E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Rate of Asthma-related Primary Care Contacts</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Time to First Asthma-related Primary Care Contact</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Rate of All On-treatment Secondary Care Contacts</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>A secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an A&amp;E contact. A participant with an A&amp;E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Rate of All On-treatment Primary Care Contacts</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Total primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional. The least square mean annual rate of all on-treatment primary care contacts along with 95% confidence interval has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Time to First Primary Care Contact</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Time to first primary care contact is measured from the date of randomization (that is, study treatment start date) to the date of first primary care contact, or study treatment stop date for participants who completed the study without any primary care contacts (censored). Analyses of time to first primary care contact will be censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Annual Rate of Severe Asthma Exacerbations</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. Least square mean for annual rate of severe asthma exacerbation along with 95% confidence interval has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Severe Asthma Exacerbation.</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Salbutamol was prescribed as a rescue medication to be used as and when necessary throughout the study. The number of salbutamol inhalers used by each participant during the study was calculated based on the total number of inhalers (adjusted to an equivalence of 200 metered actuations) prescribed. Number of salbutamol inhalers prescribed during the study was derived taking the participants time on study medication into account so it corresponds to 12 months on treatment. The least square mean number of salbutamol inhalers prescribed per participant during the study has been presented. Only participants exposed to study drug for at least 30 days were included in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Modification of Initial Therapy</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>Initial therapy is defined as the treatment that the participant was prescribed at randomization. Modification of initial therapy included any change in brand, dose or frequency of inhaler, that is, stepping up in class, dose or frequency, stepping down in class, dose or frequency, switching to another brand of inhaler, switching treatment arm or withdrawal from the study. Time to modification of initial therapy was measured from the date of randomization (that is, exposure start date) to the date of modification of initial therapy or date of treatment termination for participants who completed the study without modifiying initial therapy (censored). The number of participants with modification of initial therapy has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Have an Increase From Baseline of &gt;=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52.</measure>
    <time_frame>Baseline (Day 0) and Week 52</time_frame>
    <description>The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated &quot;total impairment&quot; and a value of 7 indicated &quot;no impairment&quot;. The total AQLQ(S) score is the mean of all 32 items in the questionnaire and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of &gt;=0.5 in AQLQ(S) total score has been presented. Only those participants available at the specified time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Have an Increase From Baseline of &gt;=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.</measure>
    <time_frame>Baseline (Day 0) and Week 52</time_frame>
    <description>The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated &quot;total impairment&quot; and a value of 7 indicated &quot;no impairment&quot;. The total environmental stimuli domain score was calculated as the mean of the items within the environmental stimuli domain. Hence, the environmental stimuli domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of &gt;=0.5 in AQLQ(S) environmental stimuli domain score has been presented. Only those participants available at the specified time point was analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>A serious advent event (SAE) of pneumonia was defined as any SAE in the adverse event special interest (AESI) group of &quot;pneumonia&quot;. The incidence of the SAEs of pneumonia for each treatment group is defined as the percentage of participants in that group who have experienced at least one SAE of pneumonia from start date of study treatment to the stop date of exposure + 28 days or date of study discontinuation, whichever is earliest. The percentage of participants with SAE of pneumonia has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First SAE of Pneumonia</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>An SAE of pneumonia was defined as any SAE in the AESI group of &quot;pneumonia&quot;. The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min [end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Fatal SAEs of Pneumonia</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>All SAEs included in the AESI group of &quot;pneumonia&quot; were considered as an SAE of pneumonia. Fatal SAEs of pneumonia are SAEs that led to death of participants. The number of participants with fatal SAEs of pneumonia has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With SAEs</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events which may require medical or surgical intervention for example, invasive or malignant cancers; all events of possible drug-induced liver injury with hyperbilirubinemia. The number of participants with on-treatment SAEs has been summarized.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Drug Reactions (ADRs)</measure>
    <time_frame>Up to Week 52</time_frame>
    <description>An ADR is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. ADRs are a subset of AEs for a given medicinal product.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4233</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>FF/VI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ICS or ICS/LABA maintenance therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>inhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluticasone furoate + vilanterol</intervention_name>
    <description>once daily via a Novel Dry Powder Inhaler</description>
    <arm_group_label>FF/VI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>inhaled corticosteroid with or without a long acting beta2-agonist</intervention_name>
    <description>ICS alone or in combination with a long acting bronchodilator</description>
    <arm_group_label>FF/VI</arm_group_label>
    <arm_group_label>ICS or ICS/LABA maintenance therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects eligible for enrolment in the study must meet all of the following criteria:&#xD;
&#xD;
          1. Informed consent: Subjects must be able to provide informed consent, have their&#xD;
             consent signed and dated.&#xD;
&#xD;
          2. Type of subject: Subjects with documented GP diagnosis of asthma as their primary&#xD;
             respiratory disease.&#xD;
&#xD;
          3. Current Anti-Asthma Therapy: All subjects must be prescribed maintenance therapy and&#xD;
             receiving ICS with or without LABA (either a fixed combination or via separate&#xD;
             inhalers), and for at least 4 weeks prior to Visit 2.&#xD;
&#xD;
               -  Other background asthma medication such as anti-leukotrienes are permitted&#xD;
&#xD;
          4. All subjects on ICS monotherapy or ICS/LABA combination (this can be a fixed dose&#xD;
             combination or an ICS alone or LABA alone in separate inhalers) must have had symptoms&#xD;
             in the past week prior to Visit 2. Symptoms are defined by daytime symptoms more than&#xD;
             twice per week, use of short-acting beta2-agonist bronchodilator more than twice per&#xD;
             week, any limitation of activities, or any nocturnal symptoms/awakening. (The symptoms&#xD;
             are based on subject's recall and are consistent with the GINA and in principal with&#xD;
             the BTS/SIGN guidelines).&#xD;
&#xD;
          5. Subject questionnaires: Subjects must be able to complete the electronic subject&#xD;
             questionnaires as well as those questionnaires that are completed by phone or provide&#xD;
             a proxy e.g. a partner/relative/a friend who can do so on their behalf&#xD;
&#xD;
          6. Gender and Age: Male or female subjects aged ≥18 years of age at Visit 1. A female is&#xD;
             eligible to enter and participate in the study if she is of:&#xD;
&#xD;
               -  Non-child bearing potential (i.e. physiologically incapable of becoming pregnant,&#xD;
                  including any female who is post-menopausal or surgically sterile). Surgically&#xD;
                  sterile females are defined as those with a documented hysterectomy and/or&#xD;
                  bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as&#xD;
                  being amenorrhoeic for greater than 1 year with an appropriate clinical profile,&#xD;
                  e.g. age appropriate, history of vasomotor symptoms. However in questionable&#xD;
                  cases, a blood sample with FSH &gt; 40MIU/ml and estradiol &lt;40pg/ml (&lt;147 pmol/L) is&#xD;
                  confirmatory.&#xD;
&#xD;
        OR Child bearing potential has a negative urine pregnancy test at Visit 2, and agrees to&#xD;
        one of the highly effective and acceptable contraceptive methods used consistently and&#xD;
        correctly (i.e. in accordance with the approved product label and the instructions of the&#xD;
        physician for the duration of the study - Visit 2 to the end of the study).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects meeting any of the following criteria must not be enrolled in the study:&#xD;
&#xD;
          1. Recent history of Life-threatening asthma: Defined for this protocol as an asthma&#xD;
             episode that required intubation and/or was associated with hypercapnea, respiratory&#xD;
             arrest or hypoxic seizures within the last 6 months.&#xD;
&#xD;
          2. COPD Respiratory Disease: A subject must not have current evidence or GP diagnosis of&#xD;
             chronic obstructive pulmonary disease.&#xD;
&#xD;
          3. Other diseases/abnormalities: Subjects with historical or current evidence of&#xD;
             uncontrolled or clinically significant disease. Significant is defined as any disease&#xD;
             that, in the opinion of the GP/ Investigator, would put the safety of the subject at&#xD;
             risk through participation, or which would affect the efficacy or safety analysis if&#xD;
             the disease/condition exacerbated during the study.&#xD;
&#xD;
          4. Drug/food allergy: Subjects with a history of hypersensitivity to any of the study&#xD;
             medications (e.g., beta2-agonists, corticosteroid) or components of the inhalation&#xD;
             powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of&#xD;
             severe milk protein allergy that, in the opinion of the GP/ Investigator,&#xD;
             contraindicates the subject's participation will also be excluded.&#xD;
&#xD;
          5. Investigational Medications: A subject must not have used any investigational drug&#xD;
             within 30 days prior to Visit 2 or within five half-lives (t½) of the prior&#xD;
             investigational study (whichever is longer of the two), (if unsure discuss with the&#xD;
             medical monitor prior to screening)&#xD;
&#xD;
          6. Chronic user of systemic corticosteroids: A subject who, in the opinion of the&#xD;
             GP/Investigator, is considered to be a chronic user of systemic corticosteroids for&#xD;
             respiratory or other indications (if unsure discuss with the medical monitor prior to&#xD;
             screening)&#xD;
&#xD;
          7. Subjects who are using LABA without an ICS as asthma maintenance therapy.&#xD;
&#xD;
          8. Subjects who plan to move away from the geographical area where the study is being&#xD;
             conducted during the study period and/or if subjects have not consented to their&#xD;
             medical records being part of the electronic medical records database that is&#xD;
             operational in the Salford area.&#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>Altrincham</city>
        <state>Cheshire</state>
        <zip>WA14 2NW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Altrincham</city>
        <state>Cheshire</state>
        <zip>WA14 5ET</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Altrincham</city>
        <state>Cheshire</state>
        <zip>WA14 5GR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Altrincham</city>
        <state>Cheshire</state>
        <zip>WA14 5NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Altrincham</city>
        <state>Cheshire</state>
        <zip>WA14 5PF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bowdon</city>
        <state>Cheshire</state>
        <zip>WA14 3BD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cheadle Hulme</city>
        <state>Cheshire</state>
        <zip>SK8 5EG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cheadle</city>
        <state>Cheshire</state>
        <zip>SK8 6LQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Edgeley</city>
        <state>Cheshire</state>
        <zip>SK3 9LQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gatley</city>
        <state>Cheshire</state>
        <zip>SK84NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Heald Green</city>
        <state>Cheshire</state>
        <zip>SK8 3QA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sale</city>
        <state>Cheshire</state>
        <zip>M33 2RH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sale</city>
        <state>Cheshire</state>
        <zip>M33 2UP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sale</city>
        <state>Cheshire</state>
        <zip>M33 4BR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sale</city>
        <state>Cheshire</state>
        <zip>M33 7SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stockport</city>
        <state>Cheshire</state>
        <zip>SK3 9NX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Timperley</city>
        <state>Cheshire</state>
        <zip>WA15 7DD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Timperley</city>
        <state>Cheshire</state>
        <zip>WA15 7UN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Altrincham</city>
        <state>Greater Manchester</state>
        <zip>WA14 2DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Altrincham</city>
        <state>Greater Manchester</state>
        <zip>WA15 6PH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Broadway, Davyhulme</city>
        <state>Greater Manchester</state>
        <zip>M41 7WJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Irlam, Manchester</city>
        <state>Greater Manchester</state>
        <zip>M44 5LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Irlam</city>
        <state>Greater Manchester</state>
        <zip>M44 5LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 1EB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 2DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 3BG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 4SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 6WF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M22 4DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M22 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M22 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M22 5RX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M22 9UE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M23 1JP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M23 1JX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M23 9AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M27 9LB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M32 0DF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M32 0PA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M32 0RW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M33 2TB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M33 3HF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M33 4WB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M33 5JD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M33 5PN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M33 7SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M33 7XN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M41 0NA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M41 0SE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M41 0TZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M41 5AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M41 7FN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M41 7WJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M41 8AA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>WA15 6BP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>WA15 7UN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Newall Green</city>
        <state>Greater Manchester</state>
        <zip>M23 2SY</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Northenden</city>
        <state>Greater Manchester</state>
        <zip>M22 4DH</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Northern Moor</city>
        <state>Greater Manchester</state>
        <zip>M23 0BX</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pendlebury</city>
        <state>Greater Manchester</state>
        <zip>M27 8HP</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salford, Manchester</city>
        <state>Greater Manchester</state>
        <zip>M6 6ES</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salford, Manchester</city>
        <state>Greater Manchester</state>
        <zip>M7 4TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salford</city>
        <state>Greater Manchester</state>
        <zip>M6 7HL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salford</city>
        <state>Greater Manchester</state>
        <zip>M7 1RD</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Stretford</city>
        <state>Greater Manchester</state>
        <zip>M32 9BD</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Timperley</city>
        <state>Greater Manchester</state>
        <zip>WA15 6PH</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Withington</city>
        <state>Greater Manchester</state>
        <zip>M20 1EY</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wythenshawe</city>
        <state>Greater Manchester</state>
        <zip>M22 0EP</zip>
        <country>United Kingdom</country>
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    </facility>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wythenshawe</city>
        <state>Greater Manchester</state>
        <zip>M22 5RN</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wythenshawe</city>
        <state>Greater Manchester</state>
        <zip>M22 5RX</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cadishead, Manchester</city>
        <zip>M44 5DD</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cheadle</city>
        <zip>SK8 5BB</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 0EA</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 0EJ</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 0LS</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 0NU</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 0PF</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 0TU</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 7JW</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
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        <zip>M30 7NA</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 8AR</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 8JA</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 8QD</zip>
        <country>United Kingdom</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eccles, Manchester</city>
        <zip>M30 9PS</zip>
        <country>United Kingdom</country>
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  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Worsley, Manchester</city>
        <zip>M28 1LZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Worsley, Manchester</city>
        <zip>M28 3AT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wythenshawe</city>
        <zip>M22 0LA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://clinicalstudydatarequest.com</url>
    <description>IPD for this study will be made available via the Clinical Study Data Request site.</description>
  </link>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <results_first_submitted>December 6, 2017</results_first_submitted>
  <results_first_submitted_qc>July 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 24, 2019</results_first_posted>
  <last_update_submitted>July 26, 2018</last_update_submitted>
  <last_update_submitted_qc>July 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>respiratory</keyword>
  <keyword>adult</keyword>
  <keyword>asthma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluticasone</mesh_term>
    <mesh_term>Xhance</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (click on the link provided below)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://clinicalstudydatarequest.com</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a multi-center, randomized, open label study to evaluate the effectiveness of fluticasone furoate (FF)/vilanterol (VI) Inhalation Powder (FF 100 micrograms [mcg]/VI 25 mcg or FF 200 mcg/VI 25 mcg) compared with usual asthma maintenance therapy in participants with asthma in a localized geographical region of United Kingdom.</recruitment_details>
      <pre_assignment_details>A total of 4725 participants were screened of which 4233 participants were randomized to either initiate with FF/VI or continue their usual asthma maintenance therapy in a ratio of 1:1. The total duration of study was approximately 12 months (52 weeks).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Usual Care</title>
          <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
        </group>
        <group group_id="P2">
          <title>FF/VI</title>
          <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2119"/>
                <participants group_id="P2" count="2114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1946"/>
                <participants group_id="P2" count="1920"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="194"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other: Subject reached stopping criteria</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="97"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Usual Care</title>
          <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
        </group>
        <group group_id="B2">
          <title>FF/VI</title>
          <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2119"/>
            <count group_id="B2" value="2114"/>
            <count group_id="B3" value="4233"/>
          </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="49.7" spread="16.69"/>
                    <measurement group_id="B2" value="49.9" spread="16.05"/>
                    <measurement group_id="B3" value="49.8" spread="16.37"/>
                  </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="1241"/>
                    <measurement group_id="B2" value="1257"/>
                    <measurement group_id="B3" value="2498"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="878"/>
                    <measurement group_id="B2" value="857"/>
                    <measurement group_id="B3" value="1735"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Count of Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African American/African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Central/South Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - Japanese Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Arabic/North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - White/Caucasian/European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2002"/>
                    <measurement group_id="B2" value="1971"/>
                    <measurement group_id="B3" value="3973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of &gt;=20 or an Increase From Baseline of &gt;=3 in ACT Total Score at Week 24.</title>
        <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of &lt;20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score &gt;=20 or an increase from Baseline of &gt;=3 has been presented</description>
        <time_frame>Baseline (Day 0) and Week 24</time_frame>
        <population>PEA Population. Only participants with non-missing ACT score were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of &gt;=20 or an Increase From Baseline of &gt;=3 in ACT Total Score at Week 24.</title>
          <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of &lt;20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score &gt;=20 or an increase from Baseline of &gt;=3 has been presented</description>
          <population>PEA Population. Only participants with non-missing ACT score were analyzed.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1399"/>
                <count group_id="O2" value="1373"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, asthma maintenance therapy (AMT) at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>2.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.70</ci_lower_limit>
            <ci_upper_limit>2.34</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Have Either an ACT Total Score of &gt;=20 or an Increase From Baseline of &gt;=3 in ACT Total Score at Weeks 12, 40 and 52.</title>
        <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score &gt;=20 or an increase from Baseline of &gt;=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
        <time_frame>Baseline (Day 0) and Weeks 12, 40 and 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Have Either an ACT Total Score of &gt;=20 or an Increase From Baseline of &gt;=3 in ACT Total Score at Weeks 12, 40 and 52.</title>
          <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score &gt;=20 or an increase from Baseline of &gt;=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12, n=2032, 2009</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2032"/>
                    <count group_id="O2" value="2009"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=1938, 1904</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1938"/>
                    <count group_id="O2" value="1904"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=1922, 1896</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1922"/>
                    <count group_id="O2" value="1896"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.67</ci_lower_limit>
            <ci_upper_limit>2.20</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care for Week 12 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.45</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care for Week 40 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.54</ci_lower_limit>
            <ci_upper_limit>2.02</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care for Week 52 has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Asthma Control (ACT Total Score &gt;=20) at Weeks 12, 24, 40 and 52.</title>
        <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score &gt;=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
        <time_frame>Weeks 12, 24, 40 and 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Asthma Control (ACT Total Score &gt;=20) at Weeks 12, 24, 40 and 52.</title>
          <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score &gt;=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12, n=2032, 2009</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2032"/>
                    <count group_id="O2" value="2009"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=1957, 1936</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1957"/>
                    <count group_id="O2" value="1936"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=1938, 1904</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1938"/>
                    <count group_id="O2" value="1904"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=1922, 1896</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1922"/>
                    <count group_id="O2" value="1896"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>2.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.82</ci_lower_limit>
            <ci_upper_limit>2.40</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.70</ci_lower_limit>
            <ci_upper_limit>2.25</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.56</ci_lower_limit>
            <ci_upper_limit>2.06</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.69</ci_lower_limit>
            <ci_upper_limit>2.24</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Have an Increase From Baseline of &gt;=3 in ACT Total Score at Weeks 12, 24, 40 and 52.</title>
        <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score &gt;=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
        <time_frame>Baseline (Day 0) and Weeks 12, 24, 40 and 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Have an Increase From Baseline of &gt;=3 in ACT Total Score at Weeks 12, 24, 40 and 52.</title>
          <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score &gt;=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12, n=2032, 2009</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2032"/>
                    <count group_id="O2" value="2009"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=1957, 1936</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1957"/>
                    <count group_id="O2" value="1936"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=1938, 1904</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1938"/>
                    <count group_id="O2" value="1904"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=1922, 1896</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1922"/>
                    <count group_id="O2" value="1896"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>2.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.98</ci_lower_limit>
            <ci_upper_limit>2.62</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>2.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.81</ci_lower_limit>
            <ci_upper_limit>2.41</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.53</ci_lower_limit>
            <ci_upper_limit>2.02</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.66</ci_lower_limit>
            <ci_upper_limit>2.21</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.</title>
        <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
        <time_frame>Baseline (Day 0) and Weeks 12, 24, 40 and 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.</title>
          <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
          <population>ITT Population</population>
          <units>Scores on ACT scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12, n=2032, 2009</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2032"/>
                    <count group_id="O2" value="2009"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.77" spread="0.087"/>
                    <measurement group_id="O2" value="3.31" spread="0.087"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=1957, 1936</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1957"/>
                    <count group_id="O2" value="1936"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.70" spread="0.093"/>
                    <measurement group_id="O2" value="3.20" spread="0.094"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40, n=1938, 1904</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1938"/>
                    <count group_id="O2" value="1904"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.63" spread="0.096"/>
                    <measurement group_id="O2" value="3.00" spread="0.097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=1922, 1896</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1922"/>
                    <count group_id="O2" value="1896"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.49" spread="0.094"/>
                    <measurement group_id="O2" value="2.99" spread="0.095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.</p_value_desc>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.54</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.30</ci_lower_limit>
            <ci_upper_limit>1.77</ci_upper_limit>
            <estimate_desc>Treatment difference of FF/VI versus Usual Care at Week 12 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.25</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
            <estimate_desc>Treatment difference of FF/VI versus Usual Care at Week 24 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.11</ci_lower_limit>
            <ci_upper_limit>1.63</ci_upper_limit>
            <estimate_desc>Treatment difference of FF/VI versus Usual Care at Week 40 has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.</p_value_desc>
            <method>MMRM</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.24</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
            <estimate_desc>Treatment difference of FF/VI versus Usual Care at Week 52 has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Each ACT Total Score Category (&gt;=20, 16 to 19, &lt;=15) at Weeks 12, 24, 40 and 52.</title>
        <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is &gt;=20, 16 to 19 and &lt;=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
        <time_frame>Weeks 12, 24, 40 and 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each ACT Total Score Category (&gt;=20, 16 to 19, &lt;=15) at Weeks 12, 24, 40 and 52.</title>
          <description>The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of &lt;=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and &gt;=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is &gt;=20, 16 to 19 and &lt;=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&gt;=20, Week 12, n=2032, 2009</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2032"/>
                    <count group_id="O2" value="2009"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 to 19, Week 12, n=2032, 2009</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2032"/>
                    <count group_id="O2" value="2009"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;=15, Week 12, n=2032, 2009</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2032"/>
                    <count group_id="O2" value="2009"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=20, Week 24, n=1957, 1936</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1957"/>
                    <count group_id="O2" value="1936"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 to 19, Week 24, n=1957, 1936</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1957"/>
                    <count group_id="O2" value="1936"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;=15, Week 24, n=1957, 1936</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1957"/>
                    <count group_id="O2" value="1936"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=20, Week 40, n=1938, 1904</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1938"/>
                    <count group_id="O2" value="1904"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 to 19, Week 40, n=1938, 1904</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1938"/>
                    <count group_id="O2" value="1904"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;=15, Week 40, n=1938, 1904</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1938"/>
                    <count group_id="O2" value="1904"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=20, Week 52, n=1922, 1896</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1922"/>
                    <count group_id="O2" value="1896"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>16 to 19, Week 52, n=1922, 1896</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1922"/>
                    <count group_id="O2" value="1896"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt;=15, Week 52, n=1922, 1896</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1922"/>
                    <count group_id="O2" value="1896"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Rate of Asthma-related Secondary Care Contacts</title>
        <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A&amp;E) contact. A participant with an A&amp;E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Rate of Asthma-related Secondary Care Contacts</title>
          <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A&amp;E) contact. A participant with an A&amp;E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented.</description>
          <population>ITT Population</population>
          <units>Contacts per participant per year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.30" lower_limit="0.25" upper_limit="0.34"/>
                    <measurement group_id="O2" value="0.30" lower_limit="0.26" upper_limit="0.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.786</p_value>
            <p_value_desc>GLM assuming negative binomial distribution (NBD) adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age</p_value_desc>
            <method>Generalized Linear Model (GLM)</method>
            <param_type>Ratio</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
            <estimate_desc>Ratio comparing FF/VI with Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Rate of Asthma-related Primary Care Contacts</title>
        <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Rate of Asthma-related Primary Care Contacts</title>
          <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented.</description>
          <population>ITT Population</population>
          <units>Contacts per participant per year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.42" lower_limit="1.36" upper_limit="1.47"/>
                    <measurement group_id="O2" value="1.45" lower_limit="1.39" upper_limit="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.461</p_value>
            <p_value_desc>GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age</p_value_desc>
            <method>Generalized Linear Model (GLM)</method>
            <param_type>Ratio</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.97</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>Ratio comparing FF/VI with Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Time to First Asthma-related Primary Care Contact</title>
        <description>Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Time to First Asthma-related Primary Care Contact</title>
          <description>Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2119"/>
                    <measurement group_id="O2" value="2114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1621"/>
                    <measurement group_id="O2" value="1599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1208"/>
                    <measurement group_id="O2" value="1214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="907"/>
                    <measurement group_id="O2" value="932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="479"/>
                    <measurement group_id="O2" value="488"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Rate of All On-treatment Secondary Care Contacts</title>
        <description>A secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an A&amp;E contact. A participant with an A&amp;E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Rate of All On-treatment Secondary Care Contacts</title>
          <description>A secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an A&amp;E contact. A participant with an A&amp;E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized.</description>
          <population>ITT Population</population>
          <units>Contacts per participant per year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.23" lower_limit="4.91" upper_limit="5.57"/>
                    <measurement group_id="O2" value="5.17" lower_limit="4.86" upper_limit="5.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.822</p_value>
            <p_value_desc>GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age</p_value_desc>
            <method>Generalized Linear Model (GLM)</method>
            <param_type>Ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>Ratio comparing FF/VI with Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Rate of All On-treatment Primary Care Contacts</title>
        <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Total primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional. The least square mean annual rate of all on-treatment primary care contacts along with 95% confidence interval has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Rate of All On-treatment Primary Care Contacts</title>
          <description>All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Total primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional. The least square mean annual rate of all on-treatment primary care contacts along with 95% confidence interval has been presented.</description>
          <population>ITT Population</population>
          <units>Contacts per participant per year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.61" lower_limit="10.26" upper_limit="10.98"/>
                    <measurement group_id="O2" value="11.64" lower_limit="11.25" upper_limit="12.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age</p_value_desc>
            <method>Generalized Linear Model (GLM)</method>
            <param_type>Ratio</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.05</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
            <estimate_desc>Ratio comparing FF/VI with Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Time to First Primary Care Contact</title>
        <description>Time to first primary care contact is measured from the date of randomization (that is, study treatment start date) to the date of first primary care contact, or study treatment stop date for participants who completed the study without any primary care contacts (censored). Analyses of time to first primary care contact will be censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Time to First Primary Care Contact</title>
          <description>Time to first primary care contact is measured from the date of randomization (that is, study treatment start date) to the date of first primary care contact, or study treatment stop date for participants who completed the study without any primary care contacts (censored). Analyses of time to first primary care contact will be censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2119"/>
                    <measurement group_id="O2" value="2114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="513"/>
                    <measurement group_id="O2" value="483"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="245"/>
                    <measurement group_id="O2" value="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 39</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                    <measurement group_id="O2" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Annual Rate of Severe Asthma Exacerbations</title>
        <description>A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. Least square mean for annual rate of severe asthma exacerbation along with 95% confidence interval has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Annual Rate of Severe Asthma Exacerbations</title>
          <description>A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. Least square mean for annual rate of severe asthma exacerbation along with 95% confidence interval has been presented.</description>
          <population>ITT Population</population>
          <units>Exacerbations per participant per year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.41" lower_limit="0.38" upper_limit="0.44"/>
                    <measurement group_id="O2" value="0.40" lower_limit="0.37" upper_limit="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.697</p_value>
            <p_value_desc>GLM assuming NBD adjusted for randomized treatment; asthma maintenance therapy and ACT total score at Baseline per randomization stratification; number of severe asthma exacerbations in previous year prior to randomization categorized; gender &amp; age</p_value_desc>
            <method>Generalized Linear Model (GLM)</method>
            <param_type>Ratio</param_type>
            <param_value>0.98</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
            <estimate_desc>Ratio comparing FF/VI with Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Severe Asthma Exacerbation.</title>
        <description>A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Severe Asthma Exacerbation.</title>
          <description>A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="654"/>
                    <measurement group_id="O2" value="634"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.504</p_value>
            <p_value_desc>Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates</p_value_desc>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.96</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.07</ci_upper_limit>
            <estimate_desc>A hazard ratio &lt;1 indicated a lower risk with FF/VI compared with Usual Care</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.</title>
        <description>Salbutamol was prescribed as a rescue medication to be used as and when necessary throughout the study. The number of salbutamol inhalers used by each participant during the study was calculated based on the total number of inhalers (adjusted to an equivalence of 200 metered actuations) prescribed. Number of salbutamol inhalers prescribed during the study was derived taking the participants time on study medication into account so it corresponds to 12 months on treatment. The least square mean number of salbutamol inhalers prescribed per participant during the study has been presented. Only participants exposed to study drug for at least 30 days were included in the analysis.</description>
        <time_frame>Up to 12 months</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.</title>
          <description>Salbutamol was prescribed as a rescue medication to be used as and when necessary throughout the study. The number of salbutamol inhalers used by each participant during the study was calculated based on the total number of inhalers (adjusted to an equivalence of 200 metered actuations) prescribed. Number of salbutamol inhalers prescribed during the study was derived taking the participants time on study medication into account so it corresponds to 12 months on treatment. The least square mean number of salbutamol inhalers prescribed per participant during the study has been presented. Only participants exposed to study drug for at least 30 days were included in the analysis.</description>
          <population>ITT Population</population>
          <units>Mean number of inhalers per participant</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2116"/>
                <count group_id="O2" value="2108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="0.11"/>
                    <measurement group_id="O2" value="7.2" spread="0.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>ANCOVA adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender,age &amp; number of salbutamol inhalers in year prior to randomization</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.1</ci_lower_limit>
            <ci_upper_limit>-0.5</ci_upper_limit>
            <estimate_desc>Difference of FF/VI versus Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Modification of Initial Therapy</title>
        <description>Initial therapy is defined as the treatment that the participant was prescribed at randomization. Modification of initial therapy included any change in brand, dose or frequency of inhaler, that is, stepping up in class, dose or frequency, stepping down in class, dose or frequency, switching to another brand of inhaler, switching treatment arm or withdrawal from the study. Time to modification of initial therapy was measured from the date of randomization (that is, exposure start date) to the date of modification of initial therapy or date of treatment termination for participants who completed the study without modifiying initial therapy (censored). The number of participants with modification of initial therapy has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Modification of Initial Therapy</title>
          <description>Initial therapy is defined as the treatment that the participant was prescribed at randomization. Modification of initial therapy included any change in brand, dose or frequency of inhaler, that is, stepping up in class, dose or frequency, stepping down in class, dose or frequency, switching to another brand of inhaler, switching treatment arm or withdrawal from the study. Time to modification of initial therapy was measured from the date of randomization (that is, exposure start date) to the date of modification of initial therapy or date of treatment termination for participants who completed the study without modifiying initial therapy (censored). The number of participants with modification of initial therapy has been presented.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488"/>
                    <measurement group_id="O2" value="563"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates</p_value_desc>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.09</ci_lower_limit>
            <ci_upper_limit>1.38</ci_upper_limit>
            <estimate_desc>Hazard ratio for FF/VI versus Usual Care has been presented</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Have an Increase From Baseline of &gt;=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52.</title>
        <description>The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated &quot;total impairment&quot; and a value of 7 indicated &quot;no impairment&quot;. The total AQLQ(S) score is the mean of all 32 items in the questionnaire and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of &gt;=0.5 in AQLQ(S) total score has been presented. Only those participants available at the specified time point was analyzed.</description>
        <time_frame>Baseline (Day 0) and Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Have an Increase From Baseline of &gt;=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52.</title>
          <description>The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated &quot;total impairment&quot; and a value of 7 indicated &quot;no impairment&quot;. The total AQLQ(S) score is the mean of all 32 items in the questionnaire and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of &gt;=0.5 in AQLQ(S) total score has been presented. Only those participants available at the specified time point was analyzed.</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1922"/>
                <count group_id="O2" value="1896"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.55</ci_lower_limit>
            <ci_upper_limit>2.06</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio of FF/VI with Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Have an Increase From Baseline of &gt;=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.</title>
        <description>The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated &quot;total impairment&quot; and a value of 7 indicated &quot;no impairment&quot;. The total environmental stimuli domain score was calculated as the mean of the items within the environmental stimuli domain. Hence, the environmental stimuli domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of &gt;=0.5 in AQLQ(S) environmental stimuli domain score has been presented. Only those participants available at the specified time point was analyzed.</description>
        <time_frame>Baseline (Day 0) and Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Have an Increase From Baseline of &gt;=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.</title>
          <description>The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated &quot;total impairment&quot; and a value of 7 indicated &quot;no impairment&quot;. The total environmental stimuli domain score was calculated as the mean of the items within the environmental stimuli domain. Hence, the environmental stimuli domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of &gt;=0.5 in AQLQ(S) environmental stimuli domain score has been presented. Only those participants available at the specified time point was analyzed.</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1922"/>
                <count group_id="O2" value="1896"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.</p_value_desc>
            <method>Regression, Logistic</method>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>1.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.31</ci_lower_limit>
            <ci_upper_limit>1.73</ci_upper_limit>
            <estimate_desc>Adjusted odds ratio of FF/VI versus Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia</title>
        <description>A serious advent event (SAE) of pneumonia was defined as any SAE in the adverse event special interest (AESI) group of &quot;pneumonia&quot;. The incidence of the SAEs of pneumonia for each treatment group is defined as the percentage of participants in that group who have experienced at least one SAE of pneumonia from start date of study treatment to the stop date of exposure + 28 days or date of study discontinuation, whichever is earliest. The percentage of participants with SAE of pneumonia has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia</title>
          <description>A serious advent event (SAE) of pneumonia was defined as any SAE in the adverse event special interest (AESI) group of &quot;pneumonia&quot;. The incidence of the SAEs of pneumonia for each treatment group is defined as the percentage of participants in that group who have experienced at least one SAE of pneumonia from start date of study treatment to the stop date of exposure + 28 days or date of study discontinuation, whichever is earliest. The percentage of participants with SAE of pneumonia has been presented.</description>
          <population>ITT Population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.</non_inferiority_desc>
            <param_type>Incidence ratio</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
            <estimate_desc>Incidence ratio was calculated as percentage of participants who had at least one SAE of pneumonia in the FF/VI group divided by the percentage of participants who had at least one SAE of pneumonia in the Usual Care group.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First SAE of Pneumonia</title>
        <description>An SAE of pneumonia was defined as any SAE in the AESI group of &quot;pneumonia&quot;. The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min [end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First SAE of Pneumonia</title>
          <description>An SAE of pneumonia was defined as any SAE in the AESI group of &quot;pneumonia&quot;. The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min [end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.255</p_value>
            <p_value_desc>Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates.</p_value_desc>
            <method>Cox proportional hazards model</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>2.74</ci_upper_limit>
            <estimate_desc>Hazard ratio for FF/VI versus Usual Care has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Fatal SAEs of Pneumonia</title>
        <description>All SAEs included in the AESI group of &quot;pneumonia&quot; were considered as an SAE of pneumonia. Fatal SAEs of pneumonia are SAEs that led to death of participants. The number of participants with fatal SAEs of pneumonia has been presented.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Fatal SAEs of Pneumonia</title>
          <description>All SAEs included in the AESI group of &quot;pneumonia&quot; were considered as an SAE of pneumonia. Fatal SAEs of pneumonia are SAEs that led to death of participants. The number of participants with fatal SAEs of pneumonia has been presented.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With SAEs</title>
        <description>An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events which may require medical or surgical intervention for example, invasive or malignant cancers; all events of possible drug-induced liver injury with hyperbilirubinemia. The number of participants with on-treatment SAEs has been summarized.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With SAEs</title>
          <description>An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events which may require medical or surgical intervention for example, invasive or malignant cancers; all events of possible drug-induced liver injury with hyperbilirubinemia. The number of participants with on-treatment SAEs has been summarized.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="284"/>
                    <measurement group_id="O2" value="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Drug Reactions (ADRs)</title>
        <description>An ADR is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. ADRs are a subset of AEs for a given medicinal product.</description>
        <time_frame>Up to Week 52</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
          </group>
          <group group_id="O2">
            <title>FF/VI</title>
            <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Drug Reactions (ADRs)</title>
          <description>An ADR is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. ADRs are a subset of AEs for a given medicinal product.</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2119"/>
                <count group_id="O2" value="2114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).</time_frame>
      <desc>ITT Population comprised of all randomized participants who received at least one prescription of study medication</desc>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).</description>
        </group>
        <group group_id="E2">
          <title>FF/VI</title>
          <description>Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</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="27" subjects_at_risk="2119"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="284" subjects_at_risk="2119"/>
                <counts group_id="E2" subjects_affected="284" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Anaemia of chronic disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy mediastinal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Microcytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="2119"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Coronary artery thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Diastolic dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hypertensive heart disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Left ventricular hypertrophy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Sinus node dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Tricuspid valve incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Branchial cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Endocardial fibroelastosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hyperparathyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Secondary hypogonadism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Angle closure glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2119"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Diabetic retinopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Incarcerated umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Umbilical hernia, obstructive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Surgical failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Mycotic allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Biliary sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="2119"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Chronic hepatitis C</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Genital infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Infected dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Infected skin ulcer</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Infective exacerbation of chronic obstructive airways disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Necrotising fasciitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Neutropenic sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="2119"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pneumonia mycoplasmal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Post procedural sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pseudomonas infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Sialoadenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2119"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Viral labyrinthitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Vulval abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Brain contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Burns third degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Comminuted fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2119"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Femoral neck fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Fibula fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Foreign body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Intentional product misuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Limb crushing injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pelvic fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="2119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Skull fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Skull fractured base</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ulna fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Wound secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>International normalised ratio abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="2119"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Renal function test abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="2119"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="2114"/>
              </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="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Metatarsalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Palindromic rheumatism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Polymyalgia rheumatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Rheumatoid arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acinic cell carcinoma of salivary gland</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Adenoma benign</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>B-cell lymphoma recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="6" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Bladder transitional cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Brain cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Brain neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Central nervous system lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Chondrosarcoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Colorectal cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Endometrial adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Gastrointestinal carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stromal tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Lentigo maligna</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Malignant melanoma in situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Metastatic renal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Oesophageal carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Penile squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Phyllodes tumour</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Precursor B-lymphoblastic lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Renal cancer recurrent</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Renal neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Thyroid cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ureteric cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Anosmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Cerebrovascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Drug withdrawal convulsions</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Haemorrhagic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Multiple sclerosis relapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Parkinson's disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Radiculopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Sensory disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Status epilepticus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Subdural hygroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>VIth nerve paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Vascular dementia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Vertebral artery dissection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Vocal cord paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion missed</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Unintended pregnancy</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Unwanted pregnancy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Alcoholism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Antisocial personality disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Delusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Depression suicidal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Eating disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hypomania</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Persistent depressive disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Schizoaffective disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="2119"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Loin pain haematuria syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ureteric obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Oedema genital</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Ovarian cyst torsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="34" subjects_affected="30" subjects_at_risk="2119"/>
                <counts group_id="E2" events="30" subjects_affected="24" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Bronchiectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pharyngeal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pickwickian syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pulmonary eosinophilia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Reflux laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Skin necrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Abortion induced</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Angiodysplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Aortic stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Essential hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Raynaud's phenomenon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Superior vena cava occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2114"/>
              </event>
              <event>
                <sub_title>Temporal arteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="2119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2114"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2119"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2114"/>
              </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>
    </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/NCT01706198
org study id: 115150
nct id: NCT01706198
lead sponsor: 
has dmc: Yes
This study is designed to compare the effectiveness and safety of Fluticasone
      Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate ((FF), GW685698)/25mcg
      Vilanterol ((VI), GW642444) or 200mcg Fluticasone Furoate ((FF), GW685698)/25mcg Vilanterol
      ((VI), GW642444) ) delivered once daily via a Novel Dry Powder Inhaler (NDPI) compared with
      the existing asthma maintenance therapy over twelve months in subjects diagnosed with asthma.
      This is a Phase III multi-centre, randomised open label study. Subjects who meet the
      eligibility criteria are randomised and will enter a 12 month treatment period.
This is a Phase III multi-centre, randomised open label study performed in subjects followed
      in primary care who have a diagnosis of and receive regular treatment for asthma in a
      localised geographical region of the UK
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24.
time frame: Baseline (Day 0) and Week 24
description: The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of <20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score >=20 or an increase from Baseline of >=3 has been presented
measure: Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.
time frame: Baseline (Day 0) and Weeks 12, 40 and 52
description: The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score >=20 or an increase from Baseline of >=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
measure: Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.
time frame: Weeks 12, 24, 40 and 52
description: The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score >=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
measure: Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.
time frame: Baseline (Day 0) and Weeks 12, 24, 40 and 52
description: The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score >=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
measure: Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.
time frame: Baseline (Day 0) and Weeks 12, 24, 40 and 52
description: The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
measure: Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
time frame: Weeks 12, 24, 40 and 52
description: The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is >=20, 16 to 19 and <=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
measure: Annual Rate of Asthma-related Secondary Care Contacts
time frame: Up to Week 52
description: All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A&E) contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented.
measure: Annual Rate of Asthma-related Primary Care Contacts
time frame: Up to Week 52
description: All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented.
measure: Number of Participants With Time to First Asthma-related Primary Care Contact
time frame: Up to Week 52
description: Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.
measure: Annual Rate of All On-treatment Secondary Care Contacts
time frame: Up to Week 52
description: A secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an A&E contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized.
measure: Annual Rate of All On-treatment Primary Care Contacts
time frame: Up to Week 52
description: All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Total primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional. The least square mean annual rate of all on-treatment primary care contacts along with 95% confidence interval has been presented.
measure: Number of Participants With Time to First Primary Care Contact
time frame: Up to Week 52
description: Time to first primary care contact is measured from the date of randomization (that is, study treatment start date) to the date of first primary care contact, or study treatment stop date for participants who completed the study without any primary care contacts (censored). Analyses of time to first primary care contact will be censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.
measure: Mean Annual Rate of Severe Asthma Exacerbations
time frame: Up to Week 52
description: A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. Least square mean for annual rate of severe asthma exacerbation along with 95% confidence interval has been presented.
measure: Time to First Severe Asthma Exacerbation.
time frame: Up to Week 52
description: A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.
measure: Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.
time frame: Up to 12 months
description: Salbutamol was prescribed as a rescue medication to be used as and when necessary throughout the study. The number of salbutamol inhalers used by each participant during the study was calculated based on the total number of inhalers (adjusted to an equivalence of 200 metered actuations) prescribed. Number of salbutamol inhalers prescribed during the study was derived taking the participants time on study medication into account so it corresponds to 12 months on treatment. The least square mean number of salbutamol inhalers prescribed per participant during the study has been presented. Only participants exposed to study drug for at least 30 days were included in the analysis.
measure: Time to Modification of Initial Therapy
time frame: Up to Week 52
description: Initial therapy is defined as the treatment that the participant was prescribed at randomization. Modification of initial therapy included any change in brand, dose or frequency of inhaler, that is, stepping up in class, dose or frequency, stepping down in class, dose or frequency, switching to another brand of inhaler, switching treatment arm or withdrawal from the study. Time to modification of initial therapy was measured from the date of randomization (that is, exposure start date) to the date of modification of initial therapy or date of treatment termination for participants who completed the study without modifiying initial therapy (censored). The number of participants with modification of initial therapy has been presented.
measure: Percentage of Participants Who Have an Increase From Baseline of >=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52.
time frame: Baseline (Day 0) and Week 52
description: The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated "total impairment" and a value of 7 indicated "no impairment". The total AQLQ(S) score is the mean of all 32 items in the questionnaire and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of >=0.5 in AQLQ(S) total score has been presented. Only those participants available at the specified time point was analyzed.
measure: Percentage of Participants Who Have an Increase From Baseline of >=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.
time frame: Baseline (Day 0) and Week 52
description: The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated "total impairment" and a value of 7 indicated "no impairment". The total environmental stimuli domain score was calculated as the mean of the items within the environmental stimuli domain. Hence, the environmental stimuli domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of >=0.5 in AQLQ(S) environmental stimuli domain score has been presented. Only those participants available at the specified time point was analyzed.
measure: Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia
time frame: Up to Week 52
description: A serious advent event (SAE) of pneumonia was defined as any SAE in the adverse event special interest (AESI) group of "pneumonia". The incidence of the SAEs of pneumonia for each treatment group is defined as the percentage of participants in that group who have experienced at least one SAE of pneumonia from start date of study treatment to the stop date of exposure + 28 days or date of study discontinuation, whichever is earliest. The percentage of participants with SAE of pneumonia has been presented.
measure: Time to First SAE of Pneumonia
time frame: Up to Week 52
description: An SAE of pneumonia was defined as any SAE in the AESI group of "pneumonia". The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min [end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented.
measure: Number of Participants With Fatal SAEs of Pneumonia
time frame: Up to Week 52
description: All SAEs included in the AESI group of "pneumonia" were considered as an SAE of pneumonia. Fatal SAEs of pneumonia are SAEs that led to death of participants. The number of participants with fatal SAEs of pneumonia has been presented.
measure: Number of Participants With SAEs
time frame: Up to Week 52
description: An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events which may require medical or surgical intervention for example, invasive or malignant cancers; all events of possible drug-induced liver injury with hyperbilirubinemia. The number of participants with on-treatment SAEs has been summarized.
measure: Number of Participants With Adverse Drug Reactions (ADRs)
time frame: Up to Week 52
description: An ADR is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. ADRs are a subset of AEs for a given medicinal product.
arm group label: FF/VI
arm group type: Experimental
description: fluticasone furoate (FF) + vilanterol (VI) once daily via a Novel Dry Powder Inhaler
arm group label: ICS or ICS/LABA maintenance therapy
arm group type: Active Comparator
description: inhaled corticosteroid (ICS) alone or in combination with a long acting beta2-agonist (LABA)
intervention type: Drug
intervention name: fluticasone furoate + vilanterol
description: once daily via a Novel Dry Powder Inhaler
arm group label: FF/VI
intervention type: Drug
intervention name: inhaled corticosteroid with or without a long acting beta2-agonist
description: ICS alone or in combination with a long acting bronchodilator
arm group label: FF/VI
arm group label: ICS or ICS/LABA maintenance therapy
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: United Kingdom
url: https://clinicalstudydatarequest.com
description: IPD for this study will be made available via the Clinical Study Data Request site.
responsible party type: Sponsor
mesh term: Asthma
mesh term: Fluticasone
mesh term: Xhance
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://clinicalstudydatarequest.com
participant flow: 
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reported events: 
certain agreements: 
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