<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/NCT04410523</url>
  </required_header>
  <id_info>
    <org_study_id>CCSJ117A12201C</org_study_id>
    <secondary_id>2019-004905-29</secondary_id>
    <nct_id>NCT04410523</nct_id>
  </id_info>
  <brief_title>Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma</brief_title>
  <official_title>A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients ≥ 18 Years of Age With Severe Uncontrolled Asthma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses&#xD;
      (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to&#xD;
      standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect&#xD;
      to change from baseline in FEV1 at the end of 12 weeks of treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomized, multicenter, multi-national, double-blind, placebo-controlled,&#xD;
      parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with&#xD;
      inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ICS) plus&#xD;
      long-acting beta agonist (LABA).&#xD;
&#xD;
      Subjects were assigned to one of the following six treatment arms/groups in a ratio of&#xD;
      2:1:1:1:2:2:&#xD;
&#xD;
        -  Placebo inhaled once daily&#xD;
&#xD;
        -  CSJ117 0.5 mg inhaled once daily&#xD;
&#xD;
        -  CSJ117 1.0 mg inhaled once daily&#xD;
&#xD;
        -  CSJ117 2.0 mg inhaled once daily&#xD;
&#xD;
        -  CSJ117 4.0 mg inhaled once daily&#xD;
&#xD;
        -  CSJ117 8.0 mg inhaled once daily&#xD;
&#xD;
      The study included:&#xD;
&#xD;
        -  A screening period of approximately 2 weeks&#xD;
&#xD;
        -  A single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects&#xD;
           experiencing an asthma exacerbation or respiratory tract infection during the run-in&#xD;
           period)&#xD;
&#xD;
        -  A double blinded treatment period of 12 weeks&#xD;
&#xD;
        -  A follow-up period of up to 12 weeks, study drug free, following the last dose of study&#xD;
           treatment.&#xD;
&#xD;
      Patients who successfully completed 12 weeks of treatment in this study could be offered&#xD;
      participation in the Safety Extension Study CCSJ117A12201E1 (NCT04946318).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor Desicion&#xD;
  </why_stopped>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Actual">September 6, 2022</completion_date>
  <primary_completion_date type="Actual">July 12, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12</measure>
    <time_frame>Baseline, Weeks 8-12</time_frame>
    <description>FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.&#xD;
Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing.&#xD;
The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind treatment at Day 1.&#xD;
The least-squares means for change from baseline in pre-dose FEV1 averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A positive average change from baseline in pre-dose FEV1 is considered a favorable outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Change From Baseline in FeNO at Week 8 and Week 12</measure>
    <time_frame>Baseline, Weeks 8-12</time_frame>
    <description>Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO).&#xD;
The baseline FeNO pre-dose measurements were taken at the end of the run-in period.&#xD;
The least-squares means for change from baseline in FeNO averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A negative average change from baseline in FeNO is considered a favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Morning PEF at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF.&#xD;
Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Evening PEF at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF.&#xD;
Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12</measure>
    <time_frame>Baseline, Weeks 8-12</time_frame>
    <description>The Asthma Control Questionnaire-5 (ACQ-5) is a five-item, self-completed questionnaire, which is used as a measure of asthma symptom control. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the overall ACQ-5 score is the mean of all 5 questions, therefore between 0 (totally controlled) and 6 (severely uncontrolled).&#xD;
The baseline values of ACQ-5 were collected at the end of the run-in period. The least-squares means for change from baseline in ACQ-5 score averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A negative change from baseline in ACQ-5 is considered a favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12</measure>
    <time_frame>Baseline, Weeks 8-12</time_frame>
    <description>The Asthma Quality of Life Questionnaire+12 (AQLQ+12) is a disease specific questionnaire, which is used as a measure of health-related quality of life. The AQLQ+12 comprises a total of 32 individual questions that span a total of 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The overall AQLQ+12 score is the mean of all 32 individual responses, therefore between 7 and 1 with higher scores indicating less impairment in health-related quality of life.&#xD;
The baseline values of AQLQ+12 were collected at the end of the run-in period. The least-squares means for change from baseline in AQLQ+12 score averaged between Week 8 and Week 12 visits were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A positive change from baseline is considered a favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ADSD Score at Week 8 and Week 12</measure>
    <time_frame>Baseline, Week 8 and Week 12</time_frame>
    <description>Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity.&#xD;
Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking.&#xD;
Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms.&#xD;
Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period.&#xD;
A negative change from baseline is a favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ANSD Score at Week 8 and Week 12</measure>
    <time_frame>Baseline, Week 8 and Week 12</time_frame>
    <description>Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity.&#xD;
Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking.&#xD;
Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms.&#xD;
Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period.&#xD;
A negative change from baseline is a favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Number of Puffs of SABA Taken Per Day at Week 12</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Participants were given a short acting β2-agonist (SABA) such as salbutamol (100 µg) or albuterol (90 µg) to use as rescue medication throughout the study. Participants recorded in the eDiary, once in the morning and once in the evening, the use of rescue medication (number of puffs of SABA taken in the previous 12 hours). The total number of puffs of SABA taken per day was calculated and the mean daily use of puffs of SABA was derived by weekly intervals.&#xD;
The baseline value of number of puffs of SABA taken per day is the average of total daily SABA use during the run-in period.&#xD;
A negative change from baseline is considered a favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period</measure>
    <time_frame>From first dose of double-blind study treatment up to last dose (Week 12)</time_frame>
    <description>Number of participants with AEs and SAEs, including asthma exacerbations, changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs during the on-treatment period.&#xD;
The on-treatment period is between the date of first dose of double-blind study treatment and date of the last dose of randomized study treatment.&#xD;
Grades to characterize the severity of the adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE). For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.&#xD;
The number of participants in each category is reported in the table.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-CSJ117 Antibodies</measure>
    <time_frame>Day 1 and Weeks 2, 4, 8, 12, 14, 16, 20 and 24</time_frame>
    <description>Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CSJ117 Serum Concentration</measure>
    <time_frame>Day 1 and Week 12: pre-dose, 2 and 4 hours post-dose; Weeks 2, 4 and 8: pre-dose and 4 hours post-dose; Weeks 14, 16, 20 and 24: pre-dose</time_frame>
    <description>CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as &quot;zero&quot;.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">335</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>CSJ117 0.5mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CSJ117 0.5 mg inhaled once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSJ117 1mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CSJ117 1 mg inhaled once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSJ117 2mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CSJ117 2 mg inhaled once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSJ117 4mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CSJ117 4 mg inhaled once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CSJ117 8mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CSJ117 8 mg inhaled once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo inhaled once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CSJ117</intervention_name>
    <description>CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.&#xD;
CSJ117 = inhaled monoclonal antibody fragment</description>
    <arm_group_label>CSJ117 0.5mg</arm_group_label>
    <arm_group_label>CSJ117 1mg</arm_group_label>
    <arm_group_label>CSJ117 2mg</arm_group_label>
    <arm_group_label>CSJ117 4mg</arm_group_label>
    <arm_group_label>CSJ117 8mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.&#xD;
Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.</description>
    <arm_group_label>CSJ117 0.5mg</arm_group_label>
    <arm_group_label>CSJ117 1mg</arm_group_label>
    <arm_group_label>CSJ117 2mg</arm_group_label>
    <arm_group_label>CSJ117 4mg</arm_group_label>
    <arm_group_label>CSJ117 8mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed asthma&#xD;
&#xD;
          -  Male and female patients aged ≥18 and ≤75 years&#xD;
&#xD;
          -  Patients who have been treated with medium or high dose ICS plus LABA with up to 2&#xD;
             additional controllers&#xD;
&#xD;
          -  Morning pre-BD FEV1 value of ≥ 40% and ≤ 85% of the predicted normal&#xD;
&#xD;
          -  A positive reversibility test&#xD;
&#xD;
          -  ACQ-5 score of ≥ 1.5 at screening and end of run-in visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have a cigarette smoking history of greater than 10 pack years or current&#xD;
             smokers&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women&#xD;
&#xD;
          -  Women of child-bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant, unless they are using specified methods of contraception during&#xD;
             dosing of study drug and until 12 weeks after last study drug treatment&#xD;
&#xD;
          -  Patients with a history of immunodeficiency disease or hepatitis B, untreated and not&#xD;
             cured hepatitis C or HIV.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>White Marsh</city>
        <state>Maryland</state>
        <zip>21162</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>North Dartmouth</city>
        <state>Massachusetts</state>
        <zip>02747-3322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boerne</city>
        <state>Texas</state>
        <zip>78006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>McKinney</city>
        <state>Texas</state>
        <zip>75069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1056ABJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1122AAK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1414AIF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <state>Buenos Aires</state>
        <zip>C1425BEN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mar del Plata</city>
        <state>Buenos Aires</state>
        <zip>7600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ranelagh, Partido De Berazate</city>
        <state>Buenos Aires</state>
        <zip>1884</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Salvador</city>
        <state>Entre Rios</state>
        <zip>E3218CHH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Concepcion del Uruguay</city>
        <state>Entre Ríos</state>
        <zip>3260</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santa Fe</city>
        <state>Rosario</state>
        <zip>S2000DBS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000DBS</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000JKR</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>T4000IFL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1900</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1125ABE</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1425FVH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Caba</city>
        <zip>C1430CAE</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mendoza</city>
        <zip>5500</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Parana</city>
        <zip>3100</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Erpent</city>
        <zip>5100</zip>
        <country>Belgium</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ruse</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <zip>L1S 2J5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <zip>L7N 3V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Etobicoke</city>
        <state>Ontario</state>
        <zip>M9V 4B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2V 2K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Trois Rivieres</city>
        <state>Quebec</state>
        <zip>G8T 7A1</zip>
        <country>Canada</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Teplice</city>
        <state>CZE</state>
        <zip>415 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <zip>377 01</zip>
        <country>Czechia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lovosice</city>
        <zip>41002</zip>
        <country>Czechia</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Varnsdorf</city>
        <zip>40747</zip>
        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Peine</city>
        <state>Niedersachsen</state>
        <zip>31224</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bamberg</city>
        <zip>96049</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>10119</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>10717</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>10969</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>12159</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Darmstadt</city>
        <zip>64283</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>60596</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20354</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>22299</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hannover</city>
        <zip>30173</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>D-04299</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>D-04347</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mainz</city>
        <zip>55128</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Potsdam</city>
        <zip>14467</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Witten</city>
        <zip>58452</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <state>GTM</state>
        <zip>01010</zip>
        <country>Guatemala</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <state>GTM</state>
        <zip>01011</zip>
        <country>Guatemala</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <zip>01010</zip>
        <country>Guatemala</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guatemala City</city>
        <zip>01011</zip>
        <country>Guatemala</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Balassagyarmat</city>
        <zip>2660</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Godollo</city>
        <zip>2100</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Komarom</city>
        <zip>2900</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Pecs</city>
        <zip>7635</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Szeged</city>
        <zip>6722</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Yokohama-city</city>
        <state>Kanagawa</state>
        <zip>223-0059</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Osaka city</city>
        <state>Osaka</state>
        <zip>530 0001</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chuo ku</city>
        <state>Tokyo</state>
        <zip>104-0031</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>103-0003</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>103-0028</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kodaira</city>
        <state>Tokyo</state>
        <zip>187-0024</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Setagaya-Ku</city>
        <state>Tokyo</state>
        <zip>157-0072</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Setagaya-ku</city>
        <state>Tokyo</state>
        <zip>158-0097</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toshima ku</city>
        <state>Tokyo</state>
        <zip>170 0003</zip>
        <country>Japan</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toshima</city>
        <state>Tokyo</state>
        <zip>170-0003</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Osaka</city>
        <zip>531-0073</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Osaka</city>
        <zip>551-0032</zip>
        <country>Japan</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Riga</city>
        <state>LV</state>
        <zip>1011</zip>
        <country>Latvia</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Riga</city>
        <state>LV</state>
        <zip>1038</zip>
        <country>Latvia</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5401</zip>
        <country>Latvia</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Daugavpils</city>
        <zip>LV-5417</zip>
        <country>Latvia</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Riga</city>
        <zip>LV 1002</zip>
        <country>Latvia</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bulacan</city>
        <zip>3020</zip>
        <country>Philippines</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Iloilo City</city>
        <zip>5000</zip>
        <country>Philippines</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Iloilo</city>
        <zip>5000</zip>
        <country>Philippines</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Manila</city>
        <zip>1000</zip>
        <country>Philippines</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Manila</city>
        <zip>1003</zip>
        <country>Philippines</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bialystok</city>
        <zip>15-044</zip>
        <country>Poland</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Krakow</city>
        <zip>30033</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Krakow</city>
        <zip>31-011</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-693</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Poznan</city>
        <zip>60-823</zip>
        <country>Poland</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Izhevsk</city>
        <zip>426061</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saratov</city>
        <zip>410012</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ulyanovsk</city>
        <zip>432063</zip>
        <country>Russian Federation</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Levice</city>
        <zip>93401</zip>
        <country>Slovakia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Presov</city>
        <zip>080 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Guatemala</country>
    <country>Hungary</country>
    <country>Japan</country>
    <country>Latvia</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
  </removed_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <results_first_submitted>July 18, 2023</results_first_submitted>
  <results_first_submitted_qc>July 18, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 7, 2023</results_first_posted>
  <disposition_first_submitted>June 7, 2023</disposition_first_submitted>
  <disposition_first_submitted_qc>June 7, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">June 13, 2023</disposition_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CSJ117</keyword>
  <keyword>uncontrolled asthma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 21, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT04410523/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 22, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT04410523/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in 116 investigative sites in 15 countries.</recruitment_details>
      <pre_assignment_details>The screening period of approximately 2 weeks began after the participants had provided written informed consent. There was a single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects experiencing an asthma exacerbation or respiratory tract infection during the run-in period) before starting the double blinded treatment period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>CSJ117 0.5mg</title>
          <description>CSJ117 0.5 mg inhaled once daily</description>
        </group>
        <group group_id="P2">
          <title>CSJ117 1mg</title>
          <description>CSJ117 1 mg inhaled once daily</description>
        </group>
        <group group_id="P3">
          <title>CSJ117 2mg</title>
          <description>CSJ117 2 mg inhaled once daily</description>
        </group>
        <group group_id="P4">
          <title>CSJ117 4mg</title>
          <description>CSJ117 4 mg inhaled once daily</description>
        </group>
        <group group_id="P5">
          <title>CSJ117 8mg</title>
          <description>CSJ117 8 mg inhaled once daily</description>
        </group>
        <group group_id="P6">
          <title>Placebo</title>
          <description>Placebo inhaled once daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="37"/>
                <participants group_id="P4" count="76"/>
                <participants group_id="P5" count="74"/>
                <participants group_id="P6" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="69"/>
                <participants group_id="P5" count="71"/>
                <participants group_id="P6" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study terminated by sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CSJ117 0.5mg</title>
          <description>CSJ117 0.5 mg inhaled once daily</description>
        </group>
        <group group_id="B2">
          <title>CSJ117 1mg</title>
          <description>CSJ117 1 mg inhaled once daily</description>
        </group>
        <group group_id="B3">
          <title>CSJ117 2mg</title>
          <description>CSJ117 2 mg inhaled once daily</description>
        </group>
        <group group_id="B4">
          <title>CSJ117 4mg</title>
          <description>CSJ117 4 mg inhaled once daily</description>
        </group>
        <group group_id="B5">
          <title>CSJ117 8mg</title>
          <description>CSJ117 8 mg inhaled once daily</description>
        </group>
        <group group_id="B6">
          <title>Placebo</title>
          <description>Placebo inhaled once daily</description>
        </group>
        <group group_id="B7">
          <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="36"/>
            <count group_id="B2" value="37"/>
            <count group_id="B3" value="37"/>
            <count group_id="B4" value="76"/>
            <count group_id="B5" value="74"/>
            <count group_id="B6" value="75"/>
            <count group_id="B7" value="335"/>
          </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="49.8" spread="12.89"/>
                    <measurement group_id="B2" value="51.2" spread="12.09"/>
                    <measurement group_id="B3" value="51.4" spread="13.31"/>
                    <measurement group_id="B4" value="50.3" spread="12.80"/>
                    <measurement group_id="B5" value="52.7" spread="12.22"/>
                    <measurement group_id="B6" value="51.5" spread="13.46"/>
                    <measurement group_id="B7" value="51.3" spread="12.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>18 - &lt;40 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40 - &lt;65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="50"/>
                    <measurement group_id="B5" value="50"/>
                    <measurement group_id="B6" value="41"/>
                    <measurement group_id="B7" value="213"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="15"/>
                    <measurement group_id="B7" value="54"/>
                  </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="27"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="43"/>
                    <measurement group_id="B5" value="48"/>
                    <measurement group_id="B6" value="45"/>
                    <measurement group_id="B7" value="209"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="33"/>
                    <measurement group_id="B5" value="26"/>
                    <measurement group_id="B6" value="30"/>
                    <measurement group_id="B7" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="56"/>
                    <measurement group_id="B5" value="52"/>
                    <measurement group_id="B6" value="53"/>
                    <measurement group_id="B7" value="243"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12</title>
        <description>FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.&#xD;
Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing.&#xD;
The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind treatment at Day 1.&#xD;
The least-squares means for change from baseline in pre-dose FEV1 averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A positive average change from baseline in pre-dose FEV1 is considered a favorable outcome.</description>
        <time_frame>Baseline, Weeks 8-12</time_frame>
        <population>Full Analysis Set (FAS). The FAS included all participants to whom double-blind treatment had been assigned and who received at least one dose of double-blind treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12</title>
          <description>FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.&#xD;
Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing.&#xD;
The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind treatment at Day 1.&#xD;
The least-squares means for change from baseline in pre-dose FEV1 averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A positive average change from baseline in pre-dose FEV1 is considered a favorable outcome.</description>
          <population>Full Analysis Set (FAS). The FAS included all participants to whom double-blind treatment had been assigned and who received at least one dose of double-blind treatment.</population>
          <units>liters (L)</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="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="76"/>
                <count group_id="O5" value="74"/>
                <count group_id="O6" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.173" spread="0.0445"/>
                    <measurement group_id="O2" value="0.109" spread="0.0446"/>
                    <measurement group_id="O3" value="0.116" spread="0.0419"/>
                    <measurement group_id="O4" value="0.060" spread="0.0299"/>
                    <measurement group_id="O5" value="0.043" spread="0.0305"/>
                    <measurement group_id="O6" value="0.051" spread="0.0309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.025</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>0.122</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0541</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.016</ci_lower_limit>
            <ci_upper_limit>0.229</ci_upper_limit>
            <estimate_desc>Treatment difference (CSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.286</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>0.058</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0542</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.049</ci_lower_limit>
            <ci_upper_limit>0.165</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.212</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>0.065</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0521</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.037</ci_lower_limit>
            <ci_upper_limit>0.168</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.831</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>0.009</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0430</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.076</ci_lower_limit>
            <ci_upper_limit>0.094</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.852</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-0.008</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.0434</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.094</ci_lower_limit>
            <ci_upper_limit>0.077</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Change From Baseline in FeNO at Week 8 and Week 12</title>
        <description>Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO).&#xD;
The baseline FeNO pre-dose measurements were taken at the end of the run-in period.&#xD;
The least-squares means for change from baseline in FeNO averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A negative average change from baseline in FeNO is considered a favorable outcome.</description>
        <time_frame>Baseline, Weeks 8-12</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Average Change From Baseline in FeNO at Week 8 and Week 12</title>
          <description>Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO).&#xD;
The baseline FeNO pre-dose measurements were taken at the end of the run-in period.&#xD;
The least-squares means for change from baseline in FeNO averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A negative average change from baseline in FeNO is considered a favorable outcome.</description>
          <population>Full Analysis Set</population>
          <units>parts per billion (ppb)</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="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="76"/>
                <count group_id="O5" value="74"/>
                <count group_id="O6" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.869" spread="1.9670"/>
                    <measurement group_id="O2" value="-5.299" spread="1.9872"/>
                    <measurement group_id="O3" value="-4.190" spread="1.8760"/>
                    <measurement group_id="O4" value="-1.587" spread="1.3312"/>
                    <measurement group_id="O5" value="-0.208" spread="1.3248"/>
                    <measurement group_id="O6" value="-1.301" spread="1.3142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.508</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-1.568</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.3630</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.219</ci_lower_limit>
            <ci_upper_limit>3.083</ci_upper_limit>
            <estimate_desc>Treatment difference (CSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.095</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-3.998</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.3840</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.691</ci_lower_limit>
            <ci_upper_limit>0.695</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.209</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-2.889</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.2943</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.405</ci_lower_limit>
            <ci_upper_limit>1.627</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.878</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-0.287</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.8718</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.971</ci_lower_limit>
            <ci_upper_limit>3.398</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.558</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>1.093</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.8652</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.578</ci_lower_limit>
            <ci_upper_limit>4.765</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Morning PEF at Week 12</title>
        <description>PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF.&#xD;
Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Morning PEF at Week 12</title>
          <description>PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF.&#xD;
Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.</description>
          <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure</population>
          <units>liters/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="32"/>
                <count group_id="O4" value="65"/>
                <count group_id="O5" value="66"/>
                <count group_id="O6" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9785" spread="22.73169"/>
                    <measurement group_id="O2" value="-1.7035" spread="28.83957"/>
                    <measurement group_id="O3" value="18.9496" spread="50.09045"/>
                    <measurement group_id="O4" value="-0.0319" spread="33.56218"/>
                    <measurement group_id="O5" value="3.5702" spread="37.05293"/>
                    <measurement group_id="O6" value="-2.2060" spread="24.56187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Evening PEF at Week 12</title>
        <description>PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF.&#xD;
Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Evening PEF at Week 12</title>
          <description>PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF.&#xD;
Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.</description>
          <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure</population>
          <units>liters/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="59"/>
                <count group_id="O5" value="62"/>
                <count group_id="O6" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.3894" spread="29.13968"/>
                    <measurement group_id="O2" value="-7.8709" spread="29.06055"/>
                    <measurement group_id="O3" value="14.0265" spread="44.90062"/>
                    <measurement group_id="O4" value="0.3893" spread="30.47064"/>
                    <measurement group_id="O5" value="2.6905" spread="32.27860"/>
                    <measurement group_id="O6" value="-3.2785" spread="22.93816"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12</title>
        <description>The Asthma Control Questionnaire-5 (ACQ-5) is a five-item, self-completed questionnaire, which is used as a measure of asthma symptom control. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the overall ACQ-5 score is the mean of all 5 questions, therefore between 0 (totally controlled) and 6 (severely uncontrolled).&#xD;
The baseline values of ACQ-5 were collected at the end of the run-in period. The least-squares means for change from baseline in ACQ-5 score averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A negative change from baseline in ACQ-5 is considered a favorable outcome.</description>
        <time_frame>Baseline, Weeks 8-12</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12</title>
          <description>The Asthma Control Questionnaire-5 (ACQ-5) is a five-item, self-completed questionnaire, which is used as a measure of asthma symptom control. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the overall ACQ-5 score is the mean of all 5 questions, therefore between 0 (totally controlled) and 6 (severely uncontrolled).&#xD;
The baseline values of ACQ-5 were collected at the end of the run-in period. The least-squares means for change from baseline in ACQ-5 score averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A negative change from baseline in ACQ-5 is considered a favorable outcome.</description>
          <population>Full Analysis Set</population>
          <units>score on a 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="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="76"/>
                <count group_id="O5" value="74"/>
                <count group_id="O6" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.764" spread="0.1230"/>
                    <measurement group_id="O2" value="-1.142" spread="0.1225"/>
                    <measurement group_id="O3" value="-1.011" spread="0.1171"/>
                    <measurement group_id="O4" value="-0.739" spread="0.0824"/>
                    <measurement group_id="O5" value="-0.837" spread="0.0829"/>
                    <measurement group_id="O6" value="-0.722" spread="0.0846"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.780</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-0.042</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1493</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.336</ci_lower_limit>
            <ci_upper_limit>0.252</ci_upper_limit>
            <estimate_desc>Treatment difference (CSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-0.420</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1489</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.713</ci_lower_limit>
            <ci_upper_limit>-0.127</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.047</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-0.289</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1446</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.573</ci_lower_limit>
            <ci_upper_limit>0.004</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.887</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-0.017</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1182</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.249</ci_lower_limit>
            <ci_upper_limit>0.216</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.333</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-0.115</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1184</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.348</ci_lower_limit>
            <ci_upper_limit>0.118</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12</title>
        <description>The Asthma Quality of Life Questionnaire+12 (AQLQ+12) is a disease specific questionnaire, which is used as a measure of health-related quality of life. The AQLQ+12 comprises a total of 32 individual questions that span a total of 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The overall AQLQ+12 score is the mean of all 32 individual responses, therefore between 7 and 1 with higher scores indicating less impairment in health-related quality of life.&#xD;
The baseline values of AQLQ+12 were collected at the end of the run-in period. The least-squares means for change from baseline in AQLQ+12 score averaged between Week 8 and Week 12 visits were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A positive change from baseline is considered a favorable outcome.</description>
        <time_frame>Baseline, Weeks 8-12</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12</title>
          <description>The Asthma Quality of Life Questionnaire+12 (AQLQ+12) is a disease specific questionnaire, which is used as a measure of health-related quality of life. The AQLQ+12 comprises a total of 32 individual questions that span a total of 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The overall AQLQ+12 score is the mean of all 32 individual responses, therefore between 7 and 1 with higher scores indicating less impairment in health-related quality of life.&#xD;
The baseline values of AQLQ+12 were collected at the end of the run-in period. The least-squares means for change from baseline in AQLQ+12 score averaged between Week 8 and Week 12 visits were obtained from a linear mixed effects model for repeated measures (MMRM).&#xD;
A positive change from baseline is considered a favorable outcome.</description>
          <population>Full Analysis Set</population>
          <units>score on a 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="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="76"/>
                <count group_id="O5" value="74"/>
                <count group_id="O6" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.467" spread="0.1223"/>
                    <measurement group_id="O2" value="0.781" spread="0.1220"/>
                    <measurement group_id="O3" value="0.642" spread="0.1177"/>
                    <measurement group_id="O4" value="0.597" spread="0.0828"/>
                    <measurement group_id="O5" value="0.636" spread="0.0826"/>
                    <measurement group_id="O6" value="0.564" spread="0.0842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.515</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>-0.097</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1485</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.389</ci_lower_limit>
            <ci_upper_limit>0.195</ci_upper_limit>
            <estimate_desc>Treatment difference (CSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.143</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>0.218</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1484</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.074</ci_lower_limit>
            <ci_upper_limit>0.510</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.590</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>0.078</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1450</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.207</ci_lower_limit>
            <ci_upper_limit>0.364</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.778</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>0.033</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1180</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.199</ci_lower_limit>
            <ci_upper_limit>0.265</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.539</p_value>
            <method>MMRM</method>
            <param_type>Least Squares mean</param_type>
            <param_value>0.073</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1180</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.160</ci_lower_limit>
            <ci_upper_limit>0.305</ci_upper_limit>
            <estimate_desc>Treatment difference (CCSJ117-placebo)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ADSD Score at Week 8 and Week 12</title>
        <description>Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity.&#xD;
Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking.&#xD;
Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms.&#xD;
Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period.&#xD;
A negative change from baseline is a favorable outcome.</description>
        <time_frame>Baseline, Week 8 and Week 12</time_frame>
        <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure at each timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ADSD Score at Week 8 and Week 12</title>
          <description>Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity.&#xD;
Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking.&#xD;
Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms.&#xD;
Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period.&#xD;
A negative change from baseline is a favorable outcome.</description>
          <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure at each timepoint</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="73"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="67"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="73"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.678"/>
                    <measurement group_id="O2" value="-0.42" spread="0.622"/>
                    <measurement group_id="O3" value="-0.35" spread="0.773"/>
                    <measurement group_id="O4" value="-0.32" spread="0.555"/>
                    <measurement group_id="O5" value="-0.33" spread="0.787"/>
                    <measurement group_id="O6" value="-0.25" spread="0.580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="32"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="65"/>
                    <count group_id="O6" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="0.752"/>
                    <measurement group_id="O2" value="-0.59" spread="0.938"/>
                    <measurement group_id="O3" value="-0.38" spread="0.687"/>
                    <measurement group_id="O4" value="-0.33" spread="0.581"/>
                    <measurement group_id="O5" value="-0.35" spread="0.820"/>
                    <measurement group_id="O6" value="-0.37" spread="0.754"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ANSD Score at Week 8 and Week 12</title>
        <description>Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity.&#xD;
Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking.&#xD;
Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms.&#xD;
Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period.&#xD;
A negative change from baseline is a favorable outcome.</description>
        <time_frame>Baseline, Week 8 and Week 12</time_frame>
        <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure at each timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ANSD Score at Week 8 and Week 12</title>
          <description>Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity.&#xD;
Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking.&#xD;
Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms.&#xD;
Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period.&#xD;
A negative change from baseline is a favorable outcome.</description>
          <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure at each timepoint</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="74"/>
                <count group_id="O5" value="72"/>
                <count group_id="O6" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.15" spread="0.637"/>
                    <measurement group_id="O2" value="-0.35" spread="0.629"/>
                    <measurement group_id="O3" value="-0.30" spread="0.760"/>
                    <measurement group_id="O4" value="-0.27" spread="0.547"/>
                    <measurement group_id="O5" value="-0.26" spread="0.753"/>
                    <measurement group_id="O6" value="-0.25" spread="0.634"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="35"/>
                    <count group_id="O4" value="70"/>
                    <count group_id="O5" value="69"/>
                    <count group_id="O6" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.19" spread="0.480"/>
                    <measurement group_id="O2" value="-0.46" spread="0.868"/>
                    <measurement group_id="O3" value="-0.29" spread="0.695"/>
                    <measurement group_id="O4" value="-0.26" spread="0.590"/>
                    <measurement group_id="O5" value="-0.23" spread="0.769"/>
                    <measurement group_id="O6" value="-0.33" spread="0.729"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Number of Puffs of SABA Taken Per Day at Week 12</title>
        <description>Participants were given a short acting β2-agonist (SABA) such as salbutamol (100 µg) or albuterol (90 µg) to use as rescue medication throughout the study. Participants recorded in the eDiary, once in the morning and once in the evening, the use of rescue medication (number of puffs of SABA taken in the previous 12 hours). The total number of puffs of SABA taken per day was calculated and the mean daily use of puffs of SABA was derived by weekly intervals.&#xD;
The baseline value of number of puffs of SABA taken per day is the average of total daily SABA use during the run-in period.&#xD;
A negative change from baseline is considered a favorable outcome.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Puffs of SABA Taken Per Day at Week 12</title>
          <description>Participants were given a short acting β2-agonist (SABA) such as salbutamol (100 µg) or albuterol (90 µg) to use as rescue medication throughout the study. Participants recorded in the eDiary, once in the morning and once in the evening, the use of rescue medication (number of puffs of SABA taken in the previous 12 hours). The total number of puffs of SABA taken per day was calculated and the mean daily use of puffs of SABA was derived by weekly intervals.&#xD;
The baseline value of number of puffs of SABA taken per day is the average of total daily SABA use during the run-in period.&#xD;
A negative change from baseline is considered a favorable outcome.</description>
          <population>Participants in the Full Analysis Set with a valid measurement for the outcome measure</population>
          <units>puffs of SABA per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
                <count group_id="O4" value="70"/>
                <count group_id="O5" value="70"/>
                <count group_id="O6" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2189" spread="0.72340"/>
                    <measurement group_id="O2" value="-0.4548" spread="0.88125"/>
                    <measurement group_id="O3" value="-0.3420" spread="0.68267"/>
                    <measurement group_id="O4" value="-0.4310" spread="0.80279"/>
                    <measurement group_id="O5" value="-0.3766" spread="0.98070"/>
                    <measurement group_id="O6" value="-0.3543" spread="0.78420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period</title>
        <description>Number of participants with AEs and SAEs, including asthma exacerbations, changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs during the on-treatment period.&#xD;
The on-treatment period is between the date of first dose of double-blind study treatment and date of the last dose of randomized study treatment.&#xD;
Grades to characterize the severity of the adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE). For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.&#xD;
The number of participants in each category is reported in the table.</description>
        <time_frame>From first dose of double-blind study treatment up to last dose (Week 12)</time_frame>
        <population>Safety Analysis Set defined as participants who received at least one dose of double-blind treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period</title>
          <description>Number of participants with AEs and SAEs, including asthma exacerbations, changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs during the on-treatment period.&#xD;
The on-treatment period is between the date of first dose of double-blind study treatment and date of the last dose of randomized study treatment.&#xD;
Grades to characterize the severity of the adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE). For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.&#xD;
The number of participants in each category is reported in the table.</description>
          <population>Safety Analysis Set defined as participants who received at least one dose of double-blind treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="76"/>
                <count group_id="O5" value="74"/>
                <count group_id="O6" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least one AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="25"/>
                    <measurement group_id="O6" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="12"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Study treatment-related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-CSJ117 Antibodies</title>
        <description>Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA).</description>
        <time_frame>Day 1 and Weeks 2, 4, 8, 12, 14, 16, 20 and 24</time_frame>
        <population>Participants in the Safety Analysis Set with a valid measurement for the outcome measure. Safety Analysis Set is defined as participants who received at least one dose of double-blind treatment. The number analyzed per row represents participants with data at the corresponding time point.</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
          <group group_id="O6">
            <title>Placebo</title>
            <description>Placebo inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-CSJ117 Antibodies</title>
          <description>Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA).</description>
          <population>Participants in the Safety Analysis Set with a valid measurement for the outcome measure. Safety Analysis Set is defined as participants who received at least one dose of double-blind treatment. The number analyzed per row represents participants with data at the corresponding time point.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="76"/>
                <count group_id="O5" value="74"/>
                <count group_id="O6" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="36"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="76"/>
                    <count group_id="O5" value="74"/>
                    <count group_id="O6" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="66"/>
                    <measurement group_id="O5" value="63"/>
                    <measurement group_id="O6" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="75"/>
                    <count group_id="O5" value="74"/>
                    <count group_id="O6" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="65"/>
                    <measurement group_id="O5" value="64"/>
                    <measurement group_id="O6" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="71"/>
                    <count group_id="O6" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="49"/>
                    <measurement group_id="O5" value="47"/>
                    <measurement group_id="O6" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="25"/>
                    <measurement group_id="O5" value="24"/>
                    <measurement group_id="O6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="72"/>
                    <count group_id="O5" value="72"/>
                    <count group_id="O6" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="22"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="50"/>
                    <measurement group_id="O5" value="54"/>
                    <measurement group_id="O6" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="35"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="71"/>
                    <count group_id="O6" value="66"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="19"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="52"/>
                    <measurement group_id="O5" value="60"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="29"/>
                    <count group_id="O4" value="59"/>
                    <count group_id="O5" value="52"/>
                    <count group_id="O6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="46"/>
                    <measurement group_id="O5" value="46"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="29"/>
                    <count group_id="O4" value="58"/>
                    <count group_id="O5" value="53"/>
                    <count group_id="O6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="46"/>
                    <measurement group_id="O5" value="46"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="29"/>
                    <count group_id="O4" value="58"/>
                    <count group_id="O5" value="53"/>
                    <count group_id="O6" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="45"/>
                    <measurement group_id="O5" value="47"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="28"/>
                    <count group_id="O4" value="56"/>
                    <count group_id="O5" value="53"/>
                    <count group_id="O6" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Negative</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Positive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="43"/>
                    <measurement group_id="O5" value="45"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>CSJ117 Serum Concentration</title>
        <description>CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as &quot;zero&quot;.</description>
        <time_frame>Day 1 and Week 12: pre-dose, 2 and 4 hours post-dose; Weeks 2, 4 and 8: pre-dose and 4 hours post-dose; Weeks 14, 16, 20 and 24: pre-dose</time_frame>
        <population>Participants in the PK set with a valid measurement for the outcome measure. PK set is defined as participants with at least one evaluable drug concentration data sample. The number analyzed per row represents participants with data at the corresponding time point.</population>
        <group_list>
          <group group_id="O1">
            <title>CSJ117 0.5mg</title>
            <description>CSJ117 0.5 mg inhaled once daily</description>
          </group>
          <group group_id="O2">
            <title>CSJ117 1mg</title>
            <description>CSJ117 1 mg inhaled once daily</description>
          </group>
          <group group_id="O3">
            <title>CSJ117 2mg</title>
            <description>CSJ117 2 mg inhaled once daily</description>
          </group>
          <group group_id="O4">
            <title>CSJ117 4mg</title>
            <description>CSJ117 4 mg inhaled once daily</description>
          </group>
          <group group_id="O5">
            <title>CSJ117 8mg</title>
            <description>CSJ117 8 mg inhaled once daily</description>
          </group>
        </group_list>
        <measure>
          <title>CSJ117 Serum Concentration</title>
          <description>CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as &quot;zero&quot;.</description>
          <population>Participants in the PK set with a valid measurement for the outcome measure. PK set is defined as participants with at least one evaluable drug concentration data sample. The number analyzed per row represents participants with data at the corresponding time point.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="37"/>
                <count group_id="O4" value="75"/>
                <count group_id="O5" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="1.34" spread="8.02"/>
                    <measurement group_id="O4" value="0.00" spread="0.00"/>
                    <measurement group_id="O5" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 2 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="1.86" spread="7.36"/>
                    <measurement group_id="O4" value="0.00" spread="0.00"/>
                    <measurement group_id="O5" value="0.157" spread="0.947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 4 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="36"/>
                    <count group_id="O2" value="37"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="1.97" spread="7.90"/>
                    <measurement group_id="O4" value="0.214" spread="1.33"/>
                    <measurement group_id="O5" value="0.924" spread="2.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="75"/>
                    <count group_id="O5" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.320" spread="1.89"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="2.32" spread="8.57"/>
                    <measurement group_id="O4" value="2.00" spread="4.74"/>
                    <measurement group_id="O5" value="6.58" spread="7.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2, 2 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="73"/>
                    <count group_id="O5" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.389" spread="2.30"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="2.20" spread="8.05"/>
                    <measurement group_id="O4" value="1.66" spread="3.51"/>
                    <measurement group_id="O5" value="7.66" spread="7.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="35"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.336" spread="1.93"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="2.89" spread="9.03"/>
                    <measurement group_id="O4" value="2.86" spread="5.11"/>
                    <measurement group_id="O5" value="12.0" spread="19.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4, 2 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.467" spread="2.68"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="3.19" spread="9.01"/>
                    <measurement group_id="O4" value="3.59" spread="5.69"/>
                    <measurement group_id="O5" value="13.8" spread="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="37"/>
                    <count group_id="O4" value="72"/>
                    <count group_id="O5" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.69" spread="4.34"/>
                    <measurement group_id="O2" value="3.15" spread="6.50"/>
                    <measurement group_id="O3" value="6.79" spread="12.0"/>
                    <measurement group_id="O4" value="11.5" spread="15.8"/>
                    <measurement group_id="O5" value="39.3" spread="51.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, 2 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="36"/>
                    <count group_id="O4" value="71"/>
                    <count group_id="O5" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.84" spread="4.69"/>
                    <measurement group_id="O2" value="3.29" spread="6.85"/>
                    <measurement group_id="O3" value="6.94" spread="12.2"/>
                    <measurement group_id="O4" value="11.1" spread="14.7"/>
                    <measurement group_id="O5" value="39.8" spread="49.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="33"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="69"/>
                    <count group_id="O5" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.83" spread="4.69"/>
                    <measurement group_id="O2" value="2.20" spread="4.61"/>
                    <measurement group_id="O3" value="10.3" spread="16.8"/>
                    <measurement group_id="O4" value="14.6" spread="20.3"/>
                    <measurement group_id="O5" value="49.5" spread="62.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, 2 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.02" spread="4.68"/>
                    <measurement group_id="O2" value="2.49" spread="4.81"/>
                    <measurement group_id="O3" value="10.2" spread="16.4"/>
                    <measurement group_id="O4" value="14.3" spread="20.3"/>
                    <measurement group_id="O5" value="45.7" spread="49.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, 4 hours post-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="68"/>
                    <count group_id="O5" value="68"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" spread="4.84"/>
                    <measurement group_id="O2" value="2.51" spread="4.79"/>
                    <measurement group_id="O3" value="10.1" spread="16.3"/>
                    <measurement group_id="O4" value="15.2" spread="20.7"/>
                    <measurement group_id="O5" value="46.7" spread="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 14, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="58"/>
                    <count group_id="O5" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.239" spread="1.19"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="2.97" spread="10.1"/>
                    <measurement group_id="O4" value="1.59" spread="4.43"/>
                    <measurement group_id="O5" value="7.26" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="57"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="2.16" spread="10.0"/>
                    <measurement group_id="O4" value="0.424" spread="1.92"/>
                    <measurement group_id="O5" value="2.53" spread="8.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="27"/>
                    <count group_id="O4" value="58"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="1.94" spread="8.99"/>
                    <measurement group_id="O4" value="0.00" spread="0.00"/>
                    <measurement group_id="O5" value="0.163" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, pre-dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="26"/>
                    <count group_id="O4" value="55"/>
                    <count group_id="O5" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.00"/>
                    <measurement group_id="O2" value="0.00" spread="0.00"/>
                    <measurement group_id="O3" value="1.86" spread="6.81"/>
                    <measurement group_id="O4" value="0.00" spread="0.00"/>
                    <measurement group_id="O5" value="0.00" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of double-blind study treatment up to 12 weeks after last dose (Week 24)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CSJ117 0.5mg</title>
          <description>CSJ117 0.5 mg inhaled once daily</description>
        </group>
        <group group_id="E2">
          <title>CSJ117 1mg</title>
          <description>CSJ117 1 mg inhaled once daily</description>
        </group>
        <group group_id="E3">
          <title>CSJ117 2mg</title>
          <description>CSJ117 2 mg inhaled once daily</description>
        </group>
        <group group_id="E4">
          <title>CSJ117 4mg</title>
          <description>CSJ117 4 mg inhaled once daily</description>
        </group>
        <group group_id="E5">
          <title>CSJ117 8mg</title>
          <description>CSJ117 1 mg inhaled once daily</description>
        </group>
        <group group_id="E6">
          <title>Placebo</title>
          <description>Placebo inhaled once daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (25.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (25.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="23" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="27" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Vaccination site swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Oral fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Papilloma viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pharyngitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Vaccination complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cervicobrachial syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Spinal cord herniation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Intermenstrual bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Chronic rhinosinusitis with nasal polyps</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="37"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="37"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="76"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="74"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="75"/>
              </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>The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862-778-8300</phone>
      <email>Novartis.email@novartis.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410523
org study id: CCSJ117A12201C
secondary id: 2019-004905-29
nct id: NCT04410523
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses
      (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to
      standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect
      to change from baseline in FEV1 at the end of 12 weeks of treatment.
This was a randomized, multicenter, multi-national, double-blind, placebo-controlled,
      parallel-arm study evaluating the effect of 5 dose levels of CSJ117 in adult subjects with
      inadequately controlled asthma despite medium to high dose inhaled corticosteroid (ICS) plus
      long-acting beta agonist (LABA).

      Subjects were assigned to one of the following six treatment arms/groups in a ratio of
      2:1:1:1:2:2:

        -  Placebo inhaled once daily

        -  CSJ117 0.5 mg inhaled once daily

        -  CSJ117 1.0 mg inhaled once daily

        -  CSJ117 2.0 mg inhaled once daily

        -  CSJ117 4.0 mg inhaled once daily

        -  CSJ117 8.0 mg inhaled once daily

      The study included:

        -  A screening period of approximately 2 weeks

        -  A single blinded placebo run-in period of 4 weeks (extended to 8 weeks for subjects
           experiencing an asthma exacerbation or respiratory tract infection during the run-in
           period)

        -  A double blinded treatment period of 12 weeks

        -  A follow-up period of up to 12 weeks, study drug free, following the last dose of study
           treatment.

      Patients who successfully completed 12 weeks of treatment in this study could be offered
      participation in the Safety Extension Study CCSJ117A12201E1 (NCT04946318).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Average Change From Baseline in Pre-dose FEV1 at Week 8 and Week 12
time frame: Baseline, Weeks 8-12
description: FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.
Pre-dose FEV1 is defined as average of the two FEV1 measurements taken at approximately 45 minutes and 15 minutes prior to dosing.
The baseline pre-dose FEV1 value is defined as the average of the values taken approximately 2 hours 45 minutes and 2 hours 15 minutes prior to the first dose of double-blind treatment at Day 1.
The least-squares means for change from baseline in pre-dose FEV1 averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).
A positive average change from baseline in pre-dose FEV1 is considered a favorable outcome.
measure: Average Change From Baseline in FeNO at Week 8 and Week 12
time frame: Baseline, Weeks 8-12
description: Fractional exhaled Nitric Oxide (FeNO) pre-dose measurements were done at the investigational sites prior to spirometry assessments. FeNO is defined as the mean of two serial measurements. The measurement of exhaled nitric oxide is widely accepted as a non-invasive marker of airway inflammation (inflammation leads to elevation of FeNO).
The baseline FeNO pre-dose measurements were taken at the end of the run-in period.
The least-squares means for change from baseline in FeNO averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).
A negative average change from baseline in FeNO is considered a favorable outcome.
measure: Change From Baseline in Morning PEF at Week 12
time frame: Baseline, Week 12
description: PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF.
Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.
measure: Change From Baseline in Evening PEF at Week 12
time frame: Baseline, Week 12
description: PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (eDiary/ePEF), once in the morning and once approximately 12 hours later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the eDiary/ePEF.
Mean morning and evening PEF values were calculated by weekly intervals. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome.
measure: Average Change From Baseline in ACQ-5 Score at Week 8 and Week 12
time frame: Baseline, Weeks 8-12
description: The Asthma Control Questionnaire-5 (ACQ-5) is a five-item, self-completed questionnaire, which is used as a measure of asthma symptom control. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the overall ACQ-5 score is the mean of all 5 questions, therefore between 0 (totally controlled) and 6 (severely uncontrolled).
The baseline values of ACQ-5 were collected at the end of the run-in period. The least-squares means for change from baseline in ACQ-5 score averaged between Week 8 and Week 12 visits for each individual dose group were obtained from a linear mixed effects model for repeated measures (MMRM).
A negative change from baseline in ACQ-5 is considered a favorable outcome.
measure: Average Change From Baseline in AQLQ+12 Score at Week 8 and Week 12
time frame: Baseline, Weeks 8-12
description: The Asthma Quality of Life Questionnaire+12 (AQLQ+12) is a disease specific questionnaire, which is used as a measure of health-related quality of life. The AQLQ+12 comprises a total of 32 individual questions that span a total of 4 domains: symptoms, activity limitation, emotional function, and environmental stimuli. Patients are asked to recall their experiences during the previous 2 weeks and to score each item on a 7-point scale (7 = not at all impaired to 1 = severely impaired). The overall AQLQ+12 score is the mean of all 32 individual responses, therefore between 7 and 1 with higher scores indicating less impairment in health-related quality of life.
The baseline values of AQLQ+12 were collected at the end of the run-in period. The least-squares means for change from baseline in AQLQ+12 score averaged between Week 8 and Week 12 visits were obtained from a linear mixed effects model for repeated measures (MMRM).
A positive change from baseline is considered a favorable outcome.
measure: Change From Baseline in ADSD Score at Week 8 and Week 12
time frame: Baseline, Week 8 and Week 12
description: Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity.
Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking.
Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms.
Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period.
A negative change from baseline is a favorable outcome.
measure: Change From Baseline in ANSD Score at Week 8 and Week 12
time frame: Baseline, Week 8 and Week 12
description: Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) are patient reported outcome measures of asthma symptom severity.
Patients recorded asthma symptoms twice daily in the eDiary. Severity of daytime asthma symptoms were assessed before going to bed and severity of nighttime symptoms upon waking.
Both diaries comprised of 6 items assessing breathing symptoms (difficulty breathing, wheezing, and shortness of breath), chest symptoms (chest tightness and chest pain), and cough symptoms (cough). All items were assessed using an 11-point numeric rating scale ranging from 0 ('None') to 10 ('As bad as you can imagine'). The overall score is the mean of all 6 individual responses, therefore between 0 and 10 with higher scores indicating more severe symptoms.
Mean daily scores of both diaries were calculated by weekly intervals. The baseline values were defined as the average score during the run-in period.
A negative change from baseline is a favorable outcome.
measure: Change From Baseline in Number of Puffs of SABA Taken Per Day at Week 12
time frame: Baseline, Week 12
description: Participants were given a short acting β2-agonist (SABA) such as salbutamol (100 µg) or albuterol (90 µg) to use as rescue medication throughout the study. Participants recorded in the eDiary, once in the morning and once in the evening, the use of rescue medication (number of puffs of SABA taken in the previous 12 hours). The total number of puffs of SABA taken per day was calculated and the mean daily use of puffs of SABA was derived by weekly intervals.
The baseline value of number of puffs of SABA taken per day is the average of total daily SABA use during the run-in period.
A negative change from baseline is considered a favorable outcome.
measure: Number of Participants With On-treatment Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-treatment Period
time frame: From first dose of double-blind study treatment up to last dose (Week 12)
description: Number of participants with AEs and SAEs, including asthma exacerbations, changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs during the on-treatment period.
The on-treatment period is between the date of first dose of double-blind study treatment and date of the last dose of randomized study treatment.
Grades to characterize the severity of the adverse events were based on the Common Terminology Criteria for Adverse Events (CTCAE). For CTCAE, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE.
The number of participants in each category is reported in the table.
measure: Number of Participants With Anti-CSJ117 Antibodies
time frame: Day 1 and Weeks 2, 4, 8, 12, 14, 16, 20 and 24
description: Immunogenicity (antibody formation against CSJ117) was evaluated in serum by a validated bridging electrochemiluminescence immunoassay (ECLIA).
measure: CSJ117 Serum Concentration
time frame: Day 1 and Week 12: pre-dose, 2 and 4 hours post-dose; Weeks 2, 4 and 8: pre-dose and 4 hours post-dose; Weeks 14, 16, 20 and 24: pre-dose
description: CSJ117 concentration was determined in serum by a validated immunoassay method. Concentrations below the lower limit of quantification (LLOQ) were treated as "zero".
arm group label: CSJ117 0.5mg
arm group type: Experimental
description: CSJ117 0.5 mg inhaled once daily
arm group label: CSJ117 1mg
arm group type: Experimental
description: CSJ117 1 mg inhaled once daily
arm group label: CSJ117 2mg
arm group type: Experimental
description: CSJ117 2 mg inhaled once daily
arm group label: CSJ117 4mg
arm group type: Experimental
description: CSJ117 4 mg inhaled once daily
arm group label: CSJ117 8mg
arm group type: Experimental
description: CSJ117 8 mg inhaled once daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo inhaled once daily
intervention type: Drug
intervention name: CSJ117
description: CSJ117 inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
CSJ117 = inhaled monoclonal antibody fragment
arm group label: CSJ117 0.5mg
arm group label: CSJ117 1mg
arm group label: CSJ117 2mg
arm group label: CSJ117 4mg
arm group label: CSJ117 8mg
intervention type: Drug
intervention name: Placebo
description: Run-in period (all arms): Placebo inhaled once daily (in the morning) for 4 weeks. Placebo dosing extended to 8 weeks in case of asthma exacerbation or respiratory tract infection during this period.
Treatment period (Placebo arm only): Placebo inhaled once daily (in the morning) for 12 weeks. Delivered via Concept1 device.
arm group label: CSJ117 0.5mg
arm group label: CSJ117 1mg
arm group label: CSJ117 2mg
arm group label: CSJ117 4mg
arm group label: CSJ117 8mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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country: Argentina
country: Belgium
country: Bulgaria
country: Canada
country: Czechia
country: Germany
country: Guatemala
country: Hungary
country: Japan
country: Latvia
country: Philippines
country: Poland
country: Russian Federation
country: Slovakia
country: United States
country: France
country: Italy
country: Korea, Republic of
country: Spain
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
provided document: 
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reported events: 
certain agreements: 
point of contact: 