<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/NCT03034967</url>
  </required_header>
  <id_info>
    <org_study_id>205724</org_study_id>
    <secondary_id>2016-003675-21</secondary_id>
    <nct_id>NCT03034967</nct_id>
  </id_info>
  <brief_title>Danirixin Dose Ranging Study in Participants With Chronic Obstructive Pulmonary Disease (COPD)</brief_title>
  <official_title>Randomised, Double-Blind (Sponsor Open), Placebo-Controlled, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of Danirixin Tablets Administered Twice Daily Compared With Placebo for 24 Weeks in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a&#xD;
      potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized,&#xD;
      double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the&#xD;
      clinical activity and safety of danirixin compared with placebo in participants with COPD.&#xD;
      Following baseline assessments collected over a 7 day period participants will be randomized&#xD;
      (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram [mg], 10 mg, 25&#xD;
      mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for&#xD;
      24 weeks. Participants will continue with their standard of care inhaled medications (i.e.&#xD;
      long acting bronchodilators with or without inhaled corticosteroids) while receiving study&#xD;
      treatment. Follow up will continue up to 28 days post last dose. Approximately 700&#xD;
      participants will be screened with a target of 540 participants completing 24 weeks of&#xD;
      treatment and key study assessments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 25, 2017</start_date>
  <completion_date type="Actual">October 5, 2018</completion_date>
  <primary_completion_date type="Actual">October 5, 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score)</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score)</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score)</measure>
    <time_frame>Baseline and Month 6</time_frame>
    <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI)</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by &quot;x&quot;, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High =&gt; 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=&gt; 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low &lt;0.6x, high &gt;4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by &quot;x&quot;, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Worst Case Vital Signs Parameter Results by PCI</measure>
    <time_frame>Up to Day 168</time_frame>
    <description>Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: &lt;90 to &gt;160 millimeters of mercury (mmHg) for SBP and &lt;40 to &gt;110 mmHg for DBP, &lt;35 or &gt;120 beats per minute for heart rate and &lt;8 or &gt;30 breaths per minute for respiration rate. Values above and below this range were considered of PCI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings</measure>
    <time_frame>Baseline and Day 168</time_frame>
    <description>Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room [ER] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and &gt;=2= participants in each treatment group who experienced 2 or more events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Responders E-RS in COPD (E-RS): COPD Total Score</measure>
    <time_frame>Month 6</time_frame>
    <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of EXACT Events Per Participant</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and &gt;=2= participants in each treatment group who experienced 2 or more events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First EXACT Event</measure>
    <time_frame>Up to Day 168</time_frame>
    <description>The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of EXACT Event</measure>
    <time_frame>Up to Day 168</time_frame>
    <description>EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EXACT Event Duration for All Events</measure>
    <time_frame>Up to Day 168</time_frame>
    <description>EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First HCRU-defined COPD Exacerbation</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Severe HCRU-defined COPD Exacerbation</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HCRU-defined Exacerbation Duration</measure>
    <time_frame>Up to Day 196</time_frame>
    <description>The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score</measure>
    <time_frame>Baseline, Days 84 and 168</time_frame>
    <description>The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of SGRQ Responder</measure>
    <time_frame>Day 84 and Day 168</time_frame>
    <description>A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline COPD Assessment Test (CAT) Total Score</measure>
    <time_frame>Baseline, Days 84 and 168</time_frame>
    <description>The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of CAT Responder</measure>
    <time_frame>Day 84 and Day 168</time_frame>
    <description>A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment</measure>
    <time_frame>Baseline, Days 84 and 168</time_frame>
    <description>Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Predicted Normal FEV1</measure>
    <time_frame>At Screening</time_frame>
    <description>Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment</measure>
    <time_frame>Baseline, Days 84 and 168</time_frame>
    <description>Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment</measure>
    <time_frame>Baseline, Days 84 and 168</time_frame>
    <description>Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Number of Puffs of Rescue Medication Per Day</measure>
    <time_frame>Baseline, Months 1, 2, 3, 4, 5 and 6</time_frame>
    <description>The mean number of puffs of rescue per day was calculated over the same time periods and using the same assumptions as rescue use via diary. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire</measure>
    <time_frame>Days 84 and 168</time_frame>
    <description>The Clinical Visit PROactive Physical Activity in COPD (C-PPAC) tool is a designed for intermittent use within a clinical study. PROactive Total Score and two domain scores (amount and difficulty) are derived using data from the C-PPAC questionnaire and a physical activity monitor worn for 7 days prior to the questionnaire.C-PPAC is a 12 item questionnaire. The PROactive tools are scored from 0 to 100 with higher scores indicating greater disease impact. It was implemented in a subset of approximately 50% of participants. The amount domain is calculated using 2 items from the C-PPAC questionnaire (amount of walking outside and chores outside) and 2 activity monitor outputs (vector magnitude units per minute (VMU/min) and steps/day). Each domain score is based on the addition of items (0-15 for amount and 0-40 for difficulty) and then scaled from 0-100. The total score is calculated as (amount+difficulty)/2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Danirixin Whole Blood Pharmacokinetic Concentration-Time Data</measure>
    <time_frame>Pre-dose on Days 1, 56, 84 and 168; 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Days 1 and 168</time_frame>
    <description>Blood samples were collected from the participants for the analysis of blood pharmacokinetic concentration-time data. All participants in the mITT population who had at least 1 non-missing Pharmacokinetic assessment obtained and analyzed whilst on treatment with danirixin were included Pharmacokinetic population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot</measure>
    <time_frame>Days 1 and 168</time_frame>
    <description>Blood samples were collected at indicated timepoints for the analysis of phamacokinetic parameter. All participants in the PK population who had at least 1 non-missing PK assessment obtained and analyzed whilst on treatment with danirixin from a dry blood spot sample and corresponding wet whole blood sample were included in Pharmacokinetic population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots</measure>
    <time_frame>Days 1 and 168</time_frame>
    <description>Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots</measure>
    <time_frame>Days 1 and 168</time_frame>
    <description>Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">614</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>Danirixin 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will receive danirixin 5 mg tablet with food twice daily along with standard care of treatment for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Danirixin 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will receive danirixin 10 mg tablet with food twice daily along with standard care of treatment for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Danirixin 25 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will receive danirixin 25 mg tablet with food twice daily along with standard care of treatment for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Danirixin 35 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will receive danirixin 35 mg tablet with food twice daily along with standard care of treatment for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Danirixin 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will receive danirixin 50 mg tablet with food twice daily along with standard care of treatment for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Eligible participants will receive placebo tablet with food twice daily along with standard care of treatment for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Danirixin</intervention_name>
    <description>Danirixin is available as 5, 10, 25, 35 and 50 mg white, film-coated, oval or round shaped tablets for oral administration.</description>
    <arm_group_label>Danirixin 10 mg</arm_group_label>
    <arm_group_label>Danirixin 25 mg</arm_group_label>
    <arm_group_label>Danirixin 35 mg</arm_group_label>
    <arm_group_label>Danirixin 5 mg</arm_group_label>
    <arm_group_label>Danirixin 50 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Danirixin matching placebo</intervention_name>
    <description>Danirixin matching placebo will be available as white, film-coated, oval or round shaped tablets for oral administration.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) during the study treatment.</description>
    <arm_group_label>Danirixin 10 mg</arm_group_label>
    <arm_group_label>Danirixin 25 mg</arm_group_label>
    <arm_group_label>Danirixin 35 mg</arm_group_label>
    <arm_group_label>Danirixin 5 mg</arm_group_label>
    <arm_group_label>Danirixin 50 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rescue medication</intervention_name>
    <description>Participants will continue to use rescue medication(s). The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.</description>
    <arm_group_label>Danirixin 10 mg</arm_group_label>
    <arm_group_label>Danirixin 25 mg</arm_group_label>
    <arm_group_label>Danirixin 35 mg</arm_group_label>
    <arm_group_label>Danirixin 5 mg</arm_group_label>
    <arm_group_label>Danirixin 50 mg</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Participants must be aged between 40 to 80 years of age inclusive, at the time of&#xD;
             signing the informed consent.&#xD;
&#xD;
          -  Participants who have COPD (post bronchodilator FEV1/FVC ratio &lt;0.7 and FEV1%&#xD;
             predicted &gt;=40%) based on American Thoracic Society (ATS)/European Respiratory Society&#xD;
             (ERS) current guidelines. Participants with a historical diagnosis of asthma may be&#xD;
             included so long as they have a current diagnosis of COPD.&#xD;
&#xD;
          -  History of respiratory symptoms including chronic cough, mucus hypersecretion, and&#xD;
             dyspnea on most days for at least the previous 3 months prior to screening.&#xD;
&#xD;
          -  Participants with a documented history of COPD exacerbation(s) in the 12 months prior&#xD;
             to study participation (screening) meeting at least one of the following criteria: &gt;=2&#xD;
             COPD exacerbations resulting in prescription for antibiotics and/or oral&#xD;
             corticosteroids or hospitalization or extended observation in a hospital emergency&#xD;
             room or outpatient center; 1 COPD exacerbation resulting in prescription for&#xD;
             antibiotics and/or oral corticosteroids of hospitalization or extended observation in&#xD;
             a hospital emergency room or outpatient center and a plasma fibrinogen concentration&#xD;
             at screening &gt;=3 grams/liter (300 milligram/deciliter)&#xD;
&#xD;
          -  Current and former smokers with a cigarette smoking history of &gt;=10 pack years (1 pack&#xD;
             year = 20 cigarettes smoked per day for 1 year or equivalent). Current smokers are&#xD;
             defined as those who are currently smoking cigarettes (i.e. have smoked at least one&#xD;
             cigarette daily or most days for the month prior to Visit 1). Former smokers are&#xD;
             defined as those who have stopped smoking for at least 6 months prior to Visit 1.&#xD;
&#xD;
          -  Participants must have the ability and willingness to use an electronic diary (log&#xD;
             pad) on a daily basis.&#xD;
&#xD;
          -  Body weight &gt;=45 kilogram (kg)&#xD;
&#xD;
          -  Male or female: A male participant must agree to use contraception during the&#xD;
             treatment period and for at least 60 hours after the last dose of study treatment,&#xD;
             corresponding to approximately 6 half-lives (which is the time needed to eliminate any&#xD;
             teratogenic study treatment) and to refrain from donating sperm during this period; A&#xD;
             female participant is eligible to participate if she is not pregnant, not&#xD;
             breastfeeding, and at least one of the following conditions applies: Not a woman of&#xD;
             childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive&#xD;
             guidance during the treatment period and for at least 60 hours after the last dose of&#xD;
             study treatment.&#xD;
&#xD;
          -  Capable of giving signed informed consent.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Diagnosis of other clinically relevant lung diseases (other than COPD), e.g.&#xD;
             sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis or lung cancer.&#xD;
&#xD;
          -  Alpha-1-antitrypsin deficiency as the underlying cause of COPD&#xD;
&#xD;
          -  Pulse oximetry &lt;88% at rest at screening. Participants should be tested while&#xD;
             breathing room air. However, participants living at high altitudes (above 5000 feet or&#xD;
             1500 meters above sea level) who are receiving supplemental oxygen can be included&#xD;
             provided they are receiving the equivalent of &lt;4 liter per minute (L/min) and&#xD;
             screening pulse oximetry is measured while on their usual oxygen settings.&#xD;
&#xD;
          -  Less than 14 days have elapsed from the completion of a course of antibiotics or oral&#xD;
             corticosteroids for a recent COPD exacerbation.&#xD;
&#xD;
          -  A peripheral blood neutrophil count &lt;1.5 x 10^9/L.&#xD;
&#xD;
          -  Diagnosis of pneumonia (chest X-ray or CT confirmed) within the 3 months prior to&#xD;
             screening.&#xD;
&#xD;
          -  Chest x-ray (posterior-anterior with lateral) or CT scan reveals evidence of a&#xD;
             clinically significant abnormality not believed to be due to the presence of COPD&#xD;
             (historic results up to 1 year prior to screening may be used). For sites in Germany:&#xD;
             If a chest x-ray (or CT scan) within 1 year prior to screening is not available,&#xD;
             approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal&#xD;
             Office of Radiation Protection (BfS).&#xD;
&#xD;
          -  History or current evidence of other clinically significant medical condition that is&#xD;
             uncontrolled on permitted therapies. Significant is defined as any disease that, in&#xD;
             the opinion of the Investigator, would put the safety of the participant at risk&#xD;
             through study participation, or that would affect the safety analysis or other&#xD;
             analysis if the disease/condition worsened during the study.&#xD;
&#xD;
          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities&#xD;
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).&#xD;
&#xD;
          -  Abnormal and clinically significant 12-lead ECG finding. The investigator will&#xD;
             determine the clinical significance of each abnormal ECG finding in relation to the&#xD;
             participant's medical history and exclude participants who would be at undue risk by&#xD;
             participating in the study. An abnormal and clinically significant finding that would&#xD;
             preclude a participant from entering the study is defined as a 12-lead tracing that is&#xD;
             interpreted as, but not limited to, any of the following: atrial fibrillation with&#xD;
             rapid ventricular rate &gt;120 beats per minute (bpm); sustained or non-sustained&#xD;
             ventricular tachycardia; second degree heart block Mobitz type II and third degree&#xD;
             heart block (unless pacemaker or defibrillator has been implanted); Corrected QT&#xD;
             Interval using Fridericia formula (QTcF) &gt;=500 millisecond (msec) in participants with&#xD;
             QRS &lt;120 msec and QTcF &gt;=530 msec in participants with QRS &gt;=120 msec.&#xD;
&#xD;
          -  Previous lung surgery (e.g. lobectomy, pneumonectomy) or lung volume reduction&#xD;
             procedure.&#xD;
&#xD;
          -  Current or expected chronic use of macrolide antibiotics during the study period for&#xD;
             the prevention of COPD exacerbations. Examples of chronic use include, but are not&#xD;
             limited to, daily or two to three times per week use for at least 3 months.&#xD;
&#xD;
          -  Oral or injectable CYP3A4 or breast cancer resistance protein (BRCP) substrates with a&#xD;
             narrow therapeutic index (CYP3A4 substrates include, but are not limited to,&#xD;
             alfenatil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine,&#xD;
             sirolimus, tacrolimus, and theophylline; BRCP substrates include, but are not limited&#xD;
             to, topotecan.) The Investigator should consult with the Medical Monitor if necessary.&#xD;
&#xD;
          -  Current or expected use of phosphodiesterase-4 inhibitors (e.g. roflumilast).&#xD;
             Participants currently receiving roflumilast may be included if they are able to&#xD;
             discontinue use from 30 days prior to screening through the completion of the follow&#xD;
             up visit.&#xD;
&#xD;
          -  Participation in a previous clinical trial and has received an investigational product&#xD;
             within any of the following time periods prior to the first dosing day in the current&#xD;
             study: 30 days, 5 half lives, or twice the duration of the biological effect of the&#xD;
             investigational product (whichever is longer).&#xD;
&#xD;
          -  Participation in a previous clinical trial with danirixin within 1 year prior to the&#xD;
             first dosing day in the current study&#xD;
&#xD;
          -  Exposure to more than four investigational products within 1 year prior to the first&#xD;
             dosing day in the current study.&#xD;
&#xD;
          -  Alanine transferase (ALT) &gt;2x upper limit of normal (ULN); bilirubin &gt; 1.5xULN&#xD;
             (isolated bilirubin &gt; 1.5xULN is acceptable if bilirubin is fractionated and direct&#xD;
             bilirubin &lt;35%).&#xD;
&#xD;
          -  A positive test for human immunodeficiency virus (HIV) antibody&#xD;
&#xD;
          -  A positive pre-study hepatitis B surface antigen or positive hepatitis C antibody&#xD;
             result within 3 months prior to screening.&#xD;
&#xD;
          -  Pulmonary rehabilitation: Participants who have taken part in the acute phase of a&#xD;
             pulmonary rehabilitation program within 4 weeks prior to screening or participants who&#xD;
             plan to enter the acute phase of a pulmonary rehabilitation program during the study.&#xD;
             Participants who are in the maintenance phase of a pulmonary rehabilitation program&#xD;
             are not excluded.&#xD;
&#xD;
          -  A history of allergy or hypersensitivity to any of the ingredients in the study&#xD;
             treatment.&#xD;
&#xD;
          -  A known or suspected history of alcohol or drug abuse within the 2 years prior to&#xD;
             screening.&#xD;
&#xD;
          -  Inability to read: in the opinion of the Investigator, any participant who is unable&#xD;
             to read and/or would not be able to complete study related materials.&#xD;
&#xD;
          -  Affiliation with the study site: study investigators, sub-investigators, study&#xD;
             coordinators, employees of a study investigator, sub-investigator or study site, or&#xD;
             immediate family member of any of the above that are involved with the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Footscray</city>
        <state>Victoria</state>
        <zip>3011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Murdoch</city>
        <state>Western Australia</state>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2K 3S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Truro</city>
        <state>Nova Scotia</state>
        <zip>B2N 1L2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 3A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gatineau</city>
        <state>Quebec</state>
        <zip>J8Y 6S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St. Charles-Borromee</city>
        <state>Quebec</state>
        <zip>J6E 2B4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quebec</city>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Darmstadt</city>
        <state>Hessen</state>
        <zip>64283</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30173</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Koblenz</city>
        <state>Rheinland-Pfalz</state>
        <zip>56068</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Leipzg</city>
        <state>Sachsen</state>
        <zip>04109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Grosshansdorf</city>
        <state>Schleswig-Holstein</state>
        <zip>22927</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10367</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10717</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Berlin</city>
        <zip>10787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucheon-Si, Gyeonggi-Do</city>
        <zip>420-021</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Incheon</city>
        <zip>403-720</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>130-709</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>130-872</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>156-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>156-755</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wonju-si, Gangwon-do</city>
        <zip>220-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Alkmaar</city>
        <zip>1815 JD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Breda</city>
        <zip>4818 CK</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hengelo</city>
        <zip>7555 DL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hoorn</city>
        <zip>1624 NP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ksawerow</city>
        <zip>95-054</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lubin</city>
        <zip>59-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ostrowiec Swietokrzyski</city>
        <zip>27-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Szczecin</city>
        <zip>71-124</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wroclaw</city>
        <zip>54-239</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bacau</city>
        <zip>600252</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <zip>050159</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cluj Napoca</city>
        <zip>400275</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cluj Napoca</city>
        <zip>400371</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Constanta</city>
        <zip>900002</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Focsani</city>
        <zip>620043</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Iasi</city>
        <zip>700115</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ramnicu Valcea</city>
        <zip>240564</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Slobozia</city>
        <zip>920013</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Suceava</city>
        <zip>720237</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pozuelo De Alarcón/Madrid</city>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Lazaar AL, Miller BE, Donald AC, Keeley T, Ambery C, Russell J, Watz H, Tal-Singer R; for 205724 Investigators. CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial. Respir Res. 2020 Jun 12;21(1):149. doi: 10.1186/s12931-020-01401-4.</citation>
    <PMID>32532258</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>September 27, 2019</results_first_submitted>
  <results_first_submitted_qc>November 11, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 29, 2019</results_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCRU exacerbations</keyword>
  <keyword>SGRQ</keyword>
  <keyword>CXCR2 antagonist</keyword>
  <keyword>GSK1325756</keyword>
  <keyword>Danirixin</keyword>
  <keyword>COPD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study is available via the Clinical Study Data Request site.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20593</ipd_url>
  </patient_data>
  <provided_document_section>
    <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>October 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03034967/SAP_000.pdf</document_url>
    </provided_document>
    <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>October 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT03034967/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study investigated the dose response and safety of danirixin compared with placebo in Chronic Obstructive Pulmonary Disease (COPD) participants with respiratory symptoms including cough, increased sputum production and dyspnoea.</recruitment_details>
      <pre_assignment_details>A total of 614 participants were randomized in this study across 9 countries.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Danirixin 5 mg</title>
          <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Danirixin 10 mg</title>
          <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="P4">
          <title>Danirixin 25 mg</title>
          <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="P5">
          <title>Danirixin 35 mg</title>
          <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="P6">
          <title>Danirixin 50 mg</title>
          <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="102"/>
                <participants group_id="P3" count="103"/>
                <participants group_id="P4" count="103"/>
                <participants group_id="P5" count="102"/>
                <participants group_id="P6" count="102"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="97"/>
                <participants group_id="P3" count="90"/>
                <participants group_id="P4" count="92"/>
                <participants group_id="P5" count="88"/>
                <participants group_id="P6" count="87"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="14"/>
                <participants group_id="P6" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Liver function test abnormality</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <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>Protocol Violation</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>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event, non-fatal</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event, Serious Fatal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <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>Placebo</title>
          <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Danirixin 5 mg</title>
          <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Danirixin 10 mg</title>
          <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="B4">
          <title>Danirixin 25 mg</title>
          <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="B5">
          <title>Danirixin 35 mg</title>
          <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="B6">
          <title>Danirixin 50 mg</title>
          <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</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="102"/>
            <count group_id="B2" value="102"/>
            <count group_id="B3" value="103"/>
            <count group_id="B4" value="103"/>
            <count group_id="B5" value="102"/>
            <count group_id="B6" value="102"/>
            <count group_id="B7" value="614"/>
          </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="66.2" spread="7.31"/>
                    <measurement group_id="B2" value="66.3" spread="6.79"/>
                    <measurement group_id="B3" value="65.7" spread="7.48"/>
                    <measurement group_id="B4" value="66.3" spread="7.28"/>
                    <measurement group_id="B5" value="65.1" spread="7.58"/>
                    <measurement group_id="B6" value="65.7" spread="6.98"/>
                    <measurement group_id="B7" value="65.9" spread="7.23"/>
                  </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="29"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="32"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="35"/>
                    <measurement group_id="B6" value="32"/>
                    <measurement group_id="B7" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="71"/>
                    <measurement group_id="B4" value="65"/>
                    <measurement group_id="B5" value="67"/>
                    <measurement group_id="B6" value="70"/>
                    <measurement group_id="B7" value="412"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Asian - East Asian Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian - South East Asian Heritage</title>
              <category_list>
                <category>
                  <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="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Arabic/North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - White/Caucasian/European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="84"/>
                    <measurement group_id="B4" value="86"/>
                    <measurement group_id="B5" value="92"/>
                    <measurement group_id="B6" value="84"/>
                    <measurement group_id="B7" value="526"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score</title>
        <description>E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified data points was analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score</title>
          <description>E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified data points was analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="91"/>
                <count group_id="O5" value="85"/>
                <count group_id="O6" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.11" spread="0.345"/>
                    <measurement group_id="O2" value="-1.93" spread="0.289"/>
                    <measurement group_id="O3" value="-1.47" spread="0.349"/>
                    <measurement group_id="O4" value="-0.87" spread="0.286"/>
                    <measurement group_id="O5" value="-0.76" spread="0.259"/>
                    <measurement group_id="O6" value="-0.71" spread="0.281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.08</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90 percent (%) credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.61</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>1.52</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>1.25</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>1.97</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>1.34</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>2.03</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>1.38</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.79</ci_lower_limit>
            <ci_upper_limit>2.07</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score)</title>
        <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>Per Protocol Population. Only those participants with available data at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score)</title>
          <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
          <population>Per Protocol Population. Only those participants with available data at the specified time points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="91"/>
                <count group_id="O5" value="85"/>
                <count group_id="O6" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.82" spread="0.202"/>
                    <measurement group_id="O2" value="-0.69" spread="0.162"/>
                    <measurement group_id="O3" value="-0.41" spread="0.183"/>
                    <measurement group_id="O4" value="-0.15" spread="0.148"/>
                    <measurement group_id="O5" value="-0.10" spread="0.141"/>
                    <measurement group_id="O6" value="-0.09" spread="0.158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.09</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.42</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.43</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.87</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.68</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.72</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.37</ci_lower_limit>
            <ci_upper_limit>1.10</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.73</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>1.12</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score)</title>
        <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>Per Protocol Population. Only those participants with available data at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score)</title>
          <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
          <population>Per Protocol Population. Only those participants with available data at the specified time points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="91"/>
                <count group_id="O5" value="85"/>
                <count group_id="O6" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.83" spread="0.107"/>
                    <measurement group_id="O2" value="-0.79" spread="0.090"/>
                    <measurement group_id="O3" value="-0.67" spread="0.109"/>
                    <measurement group_id="O4" value="-0.46" spread="0.104"/>
                    <measurement group_id="O5" value="-0.40" spread="0.088"/>
                    <measurement group_id="O6" value="-0.37" spread="0.098"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.16</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.12</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.00</ci_lower_limit>
            <ci_upper_limit>0.43</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.38</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.04</ci_lower_limit>
            <ci_upper_limit>0.61</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.42</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.21</ci_lower_limit>
            <ci_upper_limit>0.64</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>4-parameter Emax model selected.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Emax</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.45</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.26</ci_lower_limit>
            <ci_upper_limit>0.66</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score)</title>
        <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
        <time_frame>Baseline and Month 6</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score)</title>
          <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="91"/>
                <count group_id="O5" value="85"/>
                <count group_id="O6" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="0.148"/>
                    <measurement group_id="O2" value="-0.35" spread="0.061"/>
                    <measurement group_id="O3" value="-0.34" spread="0.062"/>
                    <measurement group_id="O4" value="-0.34" spread="0.069"/>
                    <measurement group_id="O5" value="-0.34" spread="0.073"/>
                    <measurement group_id="O6" value="-0.34" spread="0.078"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Log-linear model.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Log-linear</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.21</ci_lower_limit>
            <ci_upper_limit>0.23</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Log-linear model</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Log-linear</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.23</ci_lower_limit>
            <ci_upper_limit>0.25</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Log-linear model</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Log-linear</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.27</ci_lower_limit>
            <ci_upper_limit>0.29</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Log-linear model</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Log-linear</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.28</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Log-linear model</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Log-linear</non_inferiority_desc>
            <param_type>Median Posterior Difference</param_type>
            <param_value>0.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.29</ci_lower_limit>
            <ci_upper_limit>0.31</ci_upper_limit>
            <estimate_desc>Median posterior difference, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)</title>
        <description>AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>Modified Intent-to-Treat (mITT) population. mIIT population comprised of all randomized participants who were randomized apart from those randomized in error, received a treatment randomization number, modified and data for this population were based on actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)</title>
          <description>AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.</description>
          <population>Modified Intent-to-Treat (mITT) population. mIIT population comprised of all randomized participants who were randomized apart from those randomized in error, received a treatment randomization number, modified and data for this population were based on actual treatment received.</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="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="102"/>
                <count group_id="O6" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="69"/>
                    <measurement group_id="O4" value="68"/>
                    <measurement group_id="O5" value="63"/>
                    <measurement group_id="O6" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI)</title>
        <description>Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by &quot;x&quot;, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI)</title>
          <description>Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by &quot;x&quot;, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.</description>
          <population>mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles).</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="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="102"/>
                <count group_id="O6" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils, No change, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, High, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils,No change,n=97,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="98"/>
                    <measurement group_id="O5" value="100"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, High, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCHC, Low, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCHC,No change,n=97,102,101,101,102,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="102"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCHC, High, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCH, Low, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCH, No Change, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="102"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCH, High, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCV, Low, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCV, No Change, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="102"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ery. MCV, High, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, Low, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes, No change,n=97,102,101,101,102,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="99"/>
                    <measurement group_id="O3" value="97"/>
                    <measurement group_id="O4" value="97"/>
                    <measurement group_id="O5" value="99"/>
                    <measurement group_id="O6" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythrocytes. High, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, Low, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, No Change, n=97,102,101,101,102,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="102"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit, High, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, Low, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, No change, n=97,102,101,101,102,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="100"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, High, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, Low, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, No change, n=97,102,101,101,102,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="102"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes, High, n=97, 102, 101, 101, 102, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="102"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Low, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, No change, n=97,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="95"/>
                    <measurement group_id="O3" value="96"/>
                    <measurement group_id="O4" value="92"/>
                    <measurement group_id="O5" value="93"/>
                    <measurement group_id="O6" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, High, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, No change, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="100"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, High, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, Low, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, No change, n=97,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="98"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils, High, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, Low, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, No change, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="99"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="99"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets, High, n=97, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI</title>
        <description>Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High =&gt; 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=&gt; 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low &lt;0.6x, high &gt;4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by &quot;x&quot;, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles)..</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI</title>
          <description>Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High =&gt; 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=&gt; 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low &lt;0.6x, high &gt;4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by &quot;x&quot;, otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.</description>
          <population>mITT population. Only those participants with available data at the specified time points were analyzed (represented by n= X in the category titles)..</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="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="102"/>
                <count group_id="O6" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT, No change,n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="102"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, High, n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP, No change,n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="102"/>
                    <measurement group_id="O4" value="102"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP, High, n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, No change,n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="102"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, High, n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, No change, n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="102"/>
                    <measurement group_id="O4" value="102"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, High, n=99, 102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Low, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, No change, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, High, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2, Low, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2, No change, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="99"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2, High, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>Chloride, Low, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, No change, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, High, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, No change, n=96,102,101,101,101,99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="99"/>
                    <measurement group_id="O5" value="99"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, High, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct bilirubin,NoChange,n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="102"/>
                    <measurement group_id="O4" value="102"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct bilirubin,High,n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Low, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, No change, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, High, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Low, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, No change, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, High, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, No change, n=99, 102, 102, 102, 101, 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="102"/>
                    <measurement group_id="O4" value="102"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, High, n=99, 102, 102, 102, 101, 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Low, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, No change, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, High, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea, Low, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea, No change, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea, High, n=96, 102, 101, 101, 101, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="101"/>
                    <count group_id="O4" value="101"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin/ALT,No change,n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="102"/>
                    <measurement group_id="O4" value="102"/>
                    <measurement group_id="O5" value="101"/>
                    <measurement group_id="O6" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin/ALT, High,n=99,102,102,102,101,100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="99"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="101"/>
                    <count group_id="O6" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Worst Case Vital Signs Parameter Results by PCI</title>
        <description>Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: &lt;90 to &gt;160 millimeters of mercury (mmHg) for SBP and &lt;40 to &gt;110 mmHg for DBP, &lt;35 or &gt;120 beats per minute for heart rate and &lt;8 or &gt;30 breaths per minute for respiration rate. Values above and below this range were considered of PCI.</description>
        <time_frame>Up to Day 168</time_frame>
        <population>mITT population. Only those participants with available data at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Vital Signs Parameter Results by PCI</title>
          <description>Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: &lt;90 to &gt;160 millimeters of mercury (mmHg) for SBP and &lt;40 to &gt;110 mmHg for DBP, &lt;35 or &gt;120 beats per minute for heart rate and &lt;8 or &gt;30 breaths per minute for respiration rate. Values above and below this range were considered of PCI.</description>
          <population>mITT population. Only those participants with available data at the specified time points were analyzed.</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="96"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="102"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="92"/>
                    <measurement group_id="O3" value="95"/>
                    <measurement group_id="O4" value="98"/>
                    <measurement group_id="O5" value="98"/>
                    <measurement group_id="O6" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="102"/>
                    <measurement group_id="O6" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate, No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="102"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulse rate, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory rate, Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory rate, No change</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="101"/>
                    <measurement group_id="O4" value="101"/>
                    <measurement group_id="O5" value="102"/>
                    <measurement group_id="O6" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory rate, High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings</title>
        <description>Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline.</description>
        <time_frame>Baseline and Day 168</time_frame>
        <population>mITT population. Only those participants with available data at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings</title>
          <description>Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline.</description>
          <population>mITT population. Only those participants with available data at the specified time points were analyzed.</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="96"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="101"/>
                <count group_id="O4" value="101"/>
                <count group_id="O5" value="102"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not Clinical significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="65"/>
                    <measurement group_id="O3" value="68"/>
                    <measurement group_id="O4" value="67"/>
                    <measurement group_id="O5" value="62"/>
                    <measurement group_id="O6" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical significant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant</title>
        <description>Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room [ER] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and &gt;=2= participants in each treatment group who experienced 2 or more events.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>Per Protocol Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant</title>
          <description>Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room [ER] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and &gt;=2= participants in each treatment group who experienced 2 or more events.</description>
          <population>Per Protocol Population.</population>
          <units>Exacerbations per participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="61"/>
                    <measurement group_id="O4" value="63"/>
                    <measurement group_id="O5" value="55"/>
                    <measurement group_id="O6" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="28"/>
                    <measurement group_id="O5" value="30"/>
                    <measurement group_id="O6" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="15"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Responders E-RS in COPD (E-RS): COPD Total Score</title>
        <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline.</description>
        <time_frame>Month 6</time_frame>
        <population>Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responders E-RS in COPD (E-RS): COPD Total Score</title>
          <description>E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline.</description>
          <population>Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="87"/>
                <count group_id="O4" value="91"/>
                <count group_id="O5" value="85"/>
                <count group_id="O6" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="30"/>
                    <measurement group_id="O5" value="29"/>
                    <measurement group_id="O6" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.089</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.</p_value_desc>
            <method>linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.71</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.02</ci_lower_limit>
            <ci_upper_limit>2.86</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.881</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.</p_value_desc>
            <method>linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.05</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.62</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.674</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.</p_value_desc>
            <method>linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.87</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.804</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.</p_value_desc>
            <method>linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.54</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.987</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, relevant Baseline E-RS: COPD score, smoking status at Screening, country, month, Baseline by month and treatment by month interactions.</p_value_desc>
            <method>linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>1.71</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of EXACT Events Per Participant</title>
        <description>EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and &gt;=2= participants in each treatment group who experienced 2 or more events.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>Per Protocol Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of EXACT Events Per Participant</title>
          <description>EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and &gt;=2= participants in each treatment group who experienced 2 or more events.</description>
          <population>Per Protocol Population.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="92"/>
                    <measurement group_id="O3" value="92"/>
                    <measurement group_id="O4" value="92"/>
                    <measurement group_id="O5" value="86"/>
                    <measurement group_id="O6" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First EXACT Event</title>
        <description>The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1.</description>
        <time_frame>Up to Day 168</time_frame>
        <population>Per Protocol Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First EXACT Event</title>
          <description>The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1.</description>
          <population>Per Protocol Population.</population>
          <units>Days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>First quartile (Q1) time to event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O2" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O3" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O4" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O5" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O6" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median time to event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O2" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O3" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O4" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O5" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O6" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Posterior Hazard Ratio</param_type>
            <param_value>1.2</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
            <estimate_desc>Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX versus (vs.) Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted Forced Expiratory Volume in one second (FEV1)at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Posterior Hazard Ratio</param_type>
            <param_value>1.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
            <estimate_desc>Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Posterior Hazard Ratio</param_type>
            <param_value>1.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.6</ci_lower_limit>
            <ci_upper_limit>3.2</ci_upper_limit>
            <estimate_desc>Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Posterior Hazard Ratio</param_type>
            <param_value>2.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0</ci_lower_limit>
            <ci_upper_limit>4.3</ci_upper_limit>
            <estimate_desc>Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median Posterior Hazard Ratio</param_type>
            <param_value>2.0</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>4.5</ci_upper_limit>
            <estimate_desc>Median Posterior Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Severity of EXACT Event</title>
        <description>EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery.</description>
        <time_frame>Up to Day 168</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Severity of EXACT Event</title>
          <description>EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.1" spread="6.60"/>
                    <measurement group_id="O2" value="26.7" spread="3.71"/>
                    <measurement group_id="O3" value="22.9" spread="5.28"/>
                    <measurement group_id="O4" value="28.6" spread="5.68"/>
                    <measurement group_id="O5" value="25.0" spread="5.54"/>
                    <measurement group_id="O6" value="26.4" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>EXACT Event Duration for All Events</title>
        <description>EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported.</description>
        <time_frame>Up to Day 168</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>EXACT Event Duration for All Events</title>
          <description>EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="19"/>
                <count group_id="O6" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.3" spread="50.37"/>
                    <measurement group_id="O2" value="11.6" spread="10.15"/>
                    <measurement group_id="O3" value="45.8" spread="51.97"/>
                    <measurement group_id="O4" value="25.5" spread="42.11"/>
                    <measurement group_id="O5" value="17.6" spread="16.28"/>
                    <measurement group_id="O6" value="18.7" spread="37.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First HCRU-defined COPD Exacerbation</title>
        <description>The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>Per Protocol Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First HCRU-defined COPD Exacerbation</title>
          <description>The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.</description>
          <population>Per Protocol Population.</population>
          <units>Days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Q1 time to event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="63"/>
                    <measurement group_id="O4" value="79"/>
                    <measurement group_id="O5" value="70"/>
                    <measurement group_id="O6" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median time to event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O2" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O3" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O4" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O5" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O6" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.5</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator %predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.1</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.4</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0</ci_lower_limit>
            <ci_upper_limit>2.1</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.6</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1</ci_lower_limit>
            <ci_upper_limit>2.3</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Severe HCRU-defined COPD Exacerbation</title>
        <description>A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>Per Protocol Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Severe HCRU-defined COPD Exacerbation</title>
          <description>A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.</description>
          <population>Per Protocol Population.</population>
          <units>Days</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Q1 time to event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O2" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O3" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O4" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O5" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O6" value="NA">If &lt;25% of participants experienced the event within a treatment then Q1 time to event are displayed as NA (not applicable) for that treatment.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Median time to event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O2" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O3" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O4" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O5" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                    <measurement group_id="O6" value="NA">If &lt;50% of participants experienced the event within a treatment then median time to event are displayed as NA (not applicable) for that treatment.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>5.5</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.9</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>5.8</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.7</ci_lower_limit>
            <ci_upper_limit>5.6</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>2.3</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.9</ci_lower_limit>
            <ci_upper_limit>6.9</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bayesian proportional hazards model</non_inferiority_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.8</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
            <estimate_desc>Hazard Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
            <other_analysis_desc>DNX vs. Placebo statistics calculated using a Bayesian proportional hazards model including treatment, gender, exacerbation history (&lt;=1/&gt;=2 moderate/severe), smoking status at Screening, country and post-bronchodilator % predicted FEV1 at Screening.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HCRU-defined Exacerbation Duration</title>
        <description>The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event.</description>
        <time_frame>Up to Day 196</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>HCRU-defined Exacerbation Duration</title>
          <description>The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="58"/>
                <count group_id="O4" value="56"/>
                <count group_id="O5" value="66"/>
                <count group_id="O6" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="7.37"/>
                    <measurement group_id="O2" value="12.3" spread="8.95"/>
                    <measurement group_id="O3" value="12.9" spread="9.58"/>
                    <measurement group_id="O4" value="14.0" spread="8.71"/>
                    <measurement group_id="O5" value="10.7" spread="7.21"/>
                    <measurement group_id="O6" value="14.2" spread="9.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score</title>
        <description>The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
        <time_frame>Baseline, Days 84 and 168</time_frame>
        <population>Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score</title>
          <description>The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
          <population>Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 84, n=93, 97, 94, 96, 91, 90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="96"/>
                    <count group_id="O5" value="91"/>
                    <count group_id="O6" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.79" spread="1.172"/>
                    <measurement group_id="O2" value="-3.63" spread="1.150"/>
                    <measurement group_id="O3" value="-1.31" spread="1.146"/>
                    <measurement group_id="O4" value="-3.19" spread="1.148"/>
                    <measurement group_id="O5" value="-2.83" spread="1.189"/>
                    <measurement group_id="O6" value="-2.48" spread="1.175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=85, 96, 86, 90, 86, 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="96"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="90"/>
                    <count group_id="O5" value="86"/>
                    <count group_id="O6" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.11" spread="1.292"/>
                    <measurement group_id="O2" value="-3.44" spread="1.246"/>
                    <measurement group_id="O3" value="-4.19" spread="1.292"/>
                    <measurement group_id="O4" value="-4.94" spread="1.251"/>
                    <measurement group_id="O5" value="-4.12" spread="1.287"/>
                    <measurement group_id="O6" value="-3.41" spread="1.302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of SGRQ Responder</title>
        <description>A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower.</description>
        <time_frame>Day 84 and Day 168</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of SGRQ Responder</title>
          <description>A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 84, n=93, 97, 94, 96, 91, 90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="96"/>
                    <count group_id="O5" value="91"/>
                    <count group_id="O6" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="49"/>
                    <measurement group_id="O5" value="35"/>
                    <measurement group_id="O6" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=85, 96, 86, 90, 86, 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="96"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="90"/>
                    <count group_id="O5" value="86"/>
                    <count group_id="O6" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="40"/>
                    <measurement group_id="O4" value="47"/>
                    <measurement group_id="O5" value="41"/>
                    <measurement group_id="O6" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.208</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.51</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>2.59</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.482</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.27</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>2.20</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.239</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.47</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>2.53</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.426</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.31</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.763</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline SGRQ total score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>1.58</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline COPD Assessment Test (CAT) Total Score</title>
        <description>The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
        <time_frame>Baseline, Days 84 and 168</time_frame>
        <population>Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline COPD Assessment Test (CAT) Total Score</title>
          <description>The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.</description>
          <population>Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 84, n=89, 97, 92, 89, 88, 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="89"/>
                    <count group_id="O5" value="88"/>
                    <count group_id="O6" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="0.536"/>
                    <measurement group_id="O2" value="-0.86" spread="0.525"/>
                    <measurement group_id="O3" value="-0.63" spread="0.524"/>
                    <measurement group_id="O4" value="-0.55" spread="0.542"/>
                    <measurement group_id="O5" value="-1.51" spread="0.543"/>
                    <measurement group_id="O6" value="-0.36" spread="0.549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=84, 94, 86, 87, 85, 83</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="87"/>
                    <count group_id="O5" value="85"/>
                    <count group_id="O6" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.39" spread="0.557"/>
                    <measurement group_id="O2" value="-1.39" spread="0.537"/>
                    <measurement group_id="O3" value="-1.23" spread="0.548"/>
                    <measurement group_id="O4" value="-0.97" spread="0.560"/>
                    <measurement group_id="O5" value="-1.56" spread="0.560"/>
                    <measurement group_id="O6" value="-1.32" spread="0.565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of CAT Responder</title>
        <description>A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower.</description>
        <time_frame>Day 84 and Day 168</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of CAT Responder</title>
          <description>A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</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="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 84, n=89, 97, 92, 89, 88, 85</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="89"/>
                    <count group_id="O5" value="88"/>
                    <count group_id="O6" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="37"/>
                    <measurement group_id="O5" value="43"/>
                    <measurement group_id="O6" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=84, 94, 86, 87, 85, 83</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="86"/>
                    <count group_id="O4" value="87"/>
                    <count group_id="O5" value="85"/>
                    <count group_id="O6" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="44"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="42"/>
                    <measurement group_id="O5" value="46"/>
                    <measurement group_id="O6" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.973</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.01</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.58</ci_lower_limit>
            <ci_upper_limit>1.76</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 5 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.825</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.53</ci_lower_limit>
            <ci_upper_limit>1.63</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 10 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.887</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>1.66</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 25 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.567</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.21</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>2.13</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 35 mg has been presented.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.501</p_value>
            <p_value_desc>Analysis performed using a generalized linear mixed model with a logit link function including treatment, Baseline CAT score, smoking status at Screening, country, visit, Baseline by visit and treatment by visit interactions.</p_value_desc>
            <method>Linear mixed model</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.26</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.72</ci_lower_limit>
            <ci_upper_limit>2.20</ci_upper_limit>
            <estimate_desc>Odds Ratio, 90% credible interval for Placebo and Danirixin 50 mg has been presented.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment</title>
        <description>Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
        <time_frame>Baseline, Days 84 and 168</time_frame>
        <population>mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment</title>
          <description>Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
          <population>mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
          <units>Liters</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="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="102"/>
                <count group_id="O6" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 84, n=94, 99, 98, 97, 92, 93</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="98"/>
                    <count group_id="O4" value="97"/>
                    <count group_id="O5" value="92"/>
                    <count group_id="O6" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.016" spread="0.0208"/>
                    <measurement group_id="O2" value="-0.031" spread="0.0203"/>
                    <measurement group_id="O3" value="-0.029" spread="0.0204"/>
                    <measurement group_id="O4" value="-0.018" spread="0.0206"/>
                    <measurement group_id="O5" value="-0.027" spread="0.0211"/>
                    <measurement group_id="O6" value="0.027" spread="0.0210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=88, 97, 90, 90, 88, 86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="90"/>
                    <count group_id="O5" value="88"/>
                    <count group_id="O6" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.016" spread="0.0199"/>
                    <measurement group_id="O2" value="-0.043" spread="0.0191"/>
                    <measurement group_id="O3" value="-0.033" spread="0.0197"/>
                    <measurement group_id="O4" value="-0.058" spread="0.0198"/>
                    <measurement group_id="O5" value="-0.012" spread="0.0201"/>
                    <measurement group_id="O6" value="-0.011" spread="0.0202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Predicted Normal FEV1</title>
        <description>Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition.</description>
        <time_frame>At Screening</time_frame>
        <population>Per Protocol Population. Only those participants with available data at the specified time points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Predicted Normal FEV1</title>
          <description>Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition.</description>
          <population>Per Protocol Population. Only those participants with available data at the specified time points were analyzed.</population>
          <units>Percent predicted FEV1</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.98" spread="12.838"/>
                    <measurement group_id="O2" value="56.75" spread="12.038"/>
                    <measurement group_id="O3" value="56.62" spread="11.848"/>
                    <measurement group_id="O4" value="56.84" spread="12.813"/>
                    <measurement group_id="O5" value="57.51" spread="14.076"/>
                    <measurement group_id="O6" value="57.84" spread="12.794"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment</title>
        <description>Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
        <time_frame>Baseline, Days 84 and 168</time_frame>
        <population>mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment</title>
          <description>Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
          <population>mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
          <units>Liters</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="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="102"/>
                <count group_id="O6" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 84, n=94, 99, 98, 97, 92, 93</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="98"/>
                    <count group_id="O4" value="97"/>
                    <count group_id="O5" value="92"/>
                    <count group_id="O6" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.024" spread="0.0321"/>
                    <measurement group_id="O2" value="-0.054" spread="0.0313"/>
                    <measurement group_id="O3" value="-0.043" spread="0.0315"/>
                    <measurement group_id="O4" value="0.027" spread="0.0317"/>
                    <measurement group_id="O5" value="-0.049" spread="0.0326"/>
                    <measurement group_id="O6" value="0.014" spread="0.0323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=88, 97, 90, 90, 88, 86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="90"/>
                    <count group_id="O5" value="88"/>
                    <count group_id="O6" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.011" spread="0.0348"/>
                    <measurement group_id="O2" value="-0.079" spread="0.0335"/>
                    <measurement group_id="O3" value="-0.043" spread="0.0344"/>
                    <measurement group_id="O4" value="-0.024" spread="0.0345"/>
                    <measurement group_id="O5" value="-0.036" spread="0.0351"/>
                    <measurement group_id="O6" value="-0.016" spread="0.0353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment</title>
        <description>Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
        <time_frame>Baseline, Days 84 and 168</time_frame>
        <population>mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment</title>
          <description>Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.</description>
          <population>mITT Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the mITT population without missing covariate information and with at least one post baseline measurement are included in the analysis.</population>
          <units>Ratio of FEV1/FVC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="102"/>
                <count group_id="O6" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 84, n=94, 99, 98, 97, 92, 93</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="98"/>
                    <count group_id="O4" value="97"/>
                    <count group_id="O5" value="92"/>
                    <count group_id="O6" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.003" spread="0.0543"/>
                    <measurement group_id="O2" value="-0.001" spread="0.0554"/>
                    <measurement group_id="O3" value="-0.000" spread="0.0453"/>
                    <measurement group_id="O4" value="-0.013" spread="0.0630"/>
                    <measurement group_id="O5" value="-0.000" spread="0.0402"/>
                    <measurement group_id="O6" value="0.014" spread="0.1636"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=88, 97, 90, 90, 88, 86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="90"/>
                    <count group_id="O4" value="90"/>
                    <count group_id="O5" value="88"/>
                    <count group_id="O6" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.007" spread="0.0622"/>
                    <measurement group_id="O2" value="-0.003" spread="0.0555"/>
                    <measurement group_id="O3" value="0.003" spread="0.0420"/>
                    <measurement group_id="O4" value="-0.015" spread="0.0610"/>
                    <measurement group_id="O5" value="0.002" spread="0.0495"/>
                    <measurement group_id="O6" value="-0.002" spread="0.0385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Number of Puffs of Rescue Medication Per Day</title>
        <description>The mean number of puffs of rescue per day was calculated over the same time periods and using the same assumptions as rescue use via diary. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
        <time_frame>Baseline, Months 1, 2, 3, 4, 5 and 6</time_frame>
        <population>Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post Baseline measurement are included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Number of Puffs of Rescue Medication Per Day</title>
          <description>The mean number of puffs of rescue per day was calculated over the same time periods and using the same assumptions as rescue use via diary. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.</description>
          <population>Per Protocol Population. Number of participants presented represent those with data available at the time point being presented; however, all participants in the per protocol population without missing covariate information and with at least one post Baseline measurement are included in the analysis.</population>
          <units>Puffs per day</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="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1, n=100, 102, 100, 102, 98, 99</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="100"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="98"/>
                    <count group_id="O6" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.132"/>
                    <measurement group_id="O2" value="0.36" spread="0.130"/>
                    <measurement group_id="O3" value="0.28" spread="0.132"/>
                    <measurement group_id="O4" value="0.15" spread="0.130"/>
                    <measurement group_id="O5" value="-0.03" spread="0.133"/>
                    <measurement group_id="O6" value="0.28" spread="0.133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 2, n=96, 100, 98, 97, 98, 96</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="96"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="98"/>
                    <count group_id="O4" value="97"/>
                    <count group_id="O5" value="98"/>
                    <count group_id="O6" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.22" spread="0.187"/>
                    <measurement group_id="O2" value="0.42" spread="0.184"/>
                    <measurement group_id="O3" value="0.18" spread="0.186"/>
                    <measurement group_id="O4" value="0.35" spread="0.185"/>
                    <measurement group_id="O5" value="0.07" spread="0.187"/>
                    <measurement group_id="O6" value="0.33" spread="0.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3, n=95, 100, 95, 97, 94, 92</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="95"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="97"/>
                    <count group_id="O5" value="94"/>
                    <count group_id="O6" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.184"/>
                    <measurement group_id="O2" value="0.29" spread="0.181"/>
                    <measurement group_id="O3" value="0.21" spread="0.184"/>
                    <measurement group_id="O4" value="0.25" spread="0.182"/>
                    <measurement group_id="O5" value="0.07" spread="0.185"/>
                    <measurement group_id="O6" value="0.27" spread="0.186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4, n=92, 98, 92, 97, 90, 90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="98"/>
                    <count group_id="O3" value="92"/>
                    <count group_id="O4" value="97"/>
                    <count group_id="O5" value="90"/>
                    <count group_id="O6" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="0.193"/>
                    <measurement group_id="O2" value="0.27" spread="0.189"/>
                    <measurement group_id="O3" value="0.27" spread="0.192"/>
                    <measurement group_id="O4" value="0.21" spread="0.190"/>
                    <measurement group_id="O5" value="-0.04" spread="0.194"/>
                    <measurement group_id="O6" value="0.44" spread="0.195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 5, n=88, 97, 88, 94, 87, 87</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="97"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="94"/>
                    <count group_id="O5" value="87"/>
                    <count group_id="O6" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.16" spread="0.190"/>
                    <measurement group_id="O2" value="0.17" spread="0.186"/>
                    <measurement group_id="O3" value="0.19" spread="0.190"/>
                    <measurement group_id="O4" value="0.25" spread="0.187"/>
                    <measurement group_id="O5" value="-0.06" spread="0.191"/>
                    <measurement group_id="O6" value="0.29" spread="0.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6, n=86, 95, 88, 91, 85, 86</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="95"/>
                    <count group_id="O3" value="88"/>
                    <count group_id="O4" value="91"/>
                    <count group_id="O5" value="85"/>
                    <count group_id="O6" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="0.196"/>
                    <measurement group_id="O2" value="0.21" spread="0.191"/>
                    <measurement group_id="O3" value="0.10" spread="0.195"/>
                    <measurement group_id="O4" value="0.15" spread="0.193"/>
                    <measurement group_id="O5" value="0.04" spread="0.197"/>
                    <measurement group_id="O6" value="0.28" spread="0.198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire</title>
        <description>The Clinical Visit PROactive Physical Activity in COPD (C-PPAC) tool is a designed for intermittent use within a clinical study. PROactive Total Score and two domain scores (amount and difficulty) are derived using data from the C-PPAC questionnaire and a physical activity monitor worn for 7 days prior to the questionnaire.C-PPAC is a 12 item questionnaire. The PROactive tools are scored from 0 to 100 with higher scores indicating greater disease impact. It was implemented in a subset of approximately 50% of participants. The amount domain is calculated using 2 items from the C-PPAC questionnaire (amount of walking outside and chores outside) and 2 activity monitor outputs (vector magnitude units per minute (VMU/min) and steps/day). Each domain score is based on the addition of items (0-15 for amount and 0-40 for difficulty) and then scaled from 0-100. The total score is calculated as (amount+difficulty)/2.</description>
        <time_frame>Days 84 and 168</time_frame>
        <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O6">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire</title>
          <description>The Clinical Visit PROactive Physical Activity in COPD (C-PPAC) tool is a designed for intermittent use within a clinical study. PROactive Total Score and two domain scores (amount and difficulty) are derived using data from the C-PPAC questionnaire and a physical activity monitor worn for 7 days prior to the questionnaire.C-PPAC is a 12 item questionnaire. The PROactive tools are scored from 0 to 100 with higher scores indicating greater disease impact. It was implemented in a subset of approximately 50% of participants. The amount domain is calculated using 2 items from the C-PPAC questionnaire (amount of walking outside and chores outside) and 2 activity monitor outputs (vector magnitude units per minute (VMU/min) and steps/day). Each domain score is based on the addition of items (0-15 for amount and 0-40 for difficulty) and then scaled from 0-100. The total score is calculated as (amount+difficulty)/2.</description>
          <population>Per Protocol Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="103"/>
                <count group_id="O5" value="100"/>
                <count group_id="O6" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total score, Day 84, n=8, 4, 6, 6, 10, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="5.964"/>
                    <measurement group_id="O2" value="-5.75" spread="6.035"/>
                    <measurement group_id="O3" value="-3.83" spread="12.754"/>
                    <measurement group_id="O4" value="0.42" spread="2.635"/>
                    <measurement group_id="O5" value="-1.20" spread="8.453"/>
                    <measurement group_id="O6" value="2.33" spread="2.677"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total score, Day 168, n=13, 7, 9, 8, 6, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.96" spread="13.266"/>
                    <measurement group_id="O2" value="1.86" spread="9.344"/>
                    <measurement group_id="O3" value="2.11" spread="5.878"/>
                    <measurement group_id="O4" value="1.25" spread="3.423"/>
                    <measurement group_id="O5" value="4.08" spread="6.492"/>
                    <measurement group_id="O6" value="0.43" spread="7.607"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amount score, Day 84, n=8, 4, 6, 6, 10, 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.25" spread="5.825"/>
                    <measurement group_id="O2" value="-8.50" spread="7.937"/>
                    <measurement group_id="O3" value="-4.00" spread="19.204"/>
                    <measurement group_id="O4" value="0.00" spread="6.957"/>
                    <measurement group_id="O5" value="-4.20" spread="10.706"/>
                    <measurement group_id="O6" value="-0.83" spread="5.345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amount score, Day 168, n=13, 7, 9, 8, 6, 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.69" spread="14.733"/>
                    <measurement group_id="O2" value="-0.43" spread="8.810"/>
                    <measurement group_id="O3" value="2.11" spread="9.558"/>
                    <measurement group_id="O4" value="1.25" spread="9.161"/>
                    <measurement group_id="O5" value="3.67" spread="11.708"/>
                    <measurement group_id="O6" value="-4.14" spread="12.522"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficult score, Day 84, n=29, 22, 18, 19, 24, 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="22"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="19"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.38" spread="9.511"/>
                    <measurement group_id="O2" value="1.64" spread="8.301"/>
                    <measurement group_id="O3" value="-0.17" spread="7.679"/>
                    <measurement group_id="O4" value="1.89" spread="11.704"/>
                    <measurement group_id="O5" value="2.79" spread="9.278"/>
                    <measurement group_id="O6" value="4.50" spread="9.598"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficult score, Day 168, n=29, 20, 18, 19, 25, 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="19"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.03" spread="14.409"/>
                    <measurement group_id="O2" value="2.20" spread="11.039"/>
                    <measurement group_id="O3" value="2.11" spread="7.553"/>
                    <measurement group_id="O4" value="0.63" spread="11.413"/>
                    <measurement group_id="O5" value="1.52" spread="9.687"/>
                    <measurement group_id="O6" value="4.87" spread="8.887"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Danirixin Whole Blood Pharmacokinetic Concentration-Time Data</title>
        <description>Blood samples were collected from the participants for the analysis of blood pharmacokinetic concentration-time data. All participants in the mITT population who had at least 1 non-missing Pharmacokinetic assessment obtained and analyzed whilst on treatment with danirixin were included Pharmacokinetic population.</description>
        <time_frame>Pre-dose on Days 1, 56, 84 and 168; 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Days 1 and 168</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Danirixin Whole Blood Pharmacokinetic Concentration-Time Data</title>
          <description>Blood samples were collected from the participants for the analysis of blood pharmacokinetic concentration-time data. All participants in the mITT population who had at least 1 non-missing Pharmacokinetic assessment obtained and analyzed whilst on treatment with danirixin were included Pharmacokinetic population.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="103"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="102"/>
                <count group_id="O5" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, Pre-dose, n=97, 99, 102, 102, 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="99"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="102"/>
                    <count group_id="O5" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="19.41"/>
                    <measurement group_id="O2" value="0.4" spread="3.92"/>
                    <measurement group_id="O3" value="0.3" spread="3.06"/>
                    <measurement group_id="O4" value="17.2" spread="169.33"/>
                    <measurement group_id="O5" value="3.9" spread="39.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 0.5 hour, n=16, 19, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.7" spread="85.73"/>
                    <measurement group_id="O2" value="210.4" spread="207.54"/>
                    <measurement group_id="O3" value="730.5" spread="1046.42"/>
                    <measurement group_id="O4" value="976.1" spread="839.37"/>
                    <measurement group_id="O5" value="1331.0" spread="1220.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 1 hour, n=16, 18, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148.3" spread="104.75"/>
                    <measurement group_id="O2" value="343.3" spread="228.66"/>
                    <measurement group_id="O3" value="822.0" spread="527.47"/>
                    <measurement group_id="O4" value="1183.5" spread="760.02"/>
                    <measurement group_id="O5" value="1846.2" spread="979.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 2 hours, n=16, 19, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.3" spread="46.00"/>
                    <measurement group_id="O2" value="277.7" spread="245.32"/>
                    <measurement group_id="O3" value="707.7" spread="256.63"/>
                    <measurement group_id="O4" value="1011.2" spread="398.82"/>
                    <measurement group_id="O5" value="1472.8" spread="858.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 4 hours, n=16, 19, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.2" spread="17.79"/>
                    <measurement group_id="O2" value="165.3" spread="136.50"/>
                    <measurement group_id="O3" value="401.5" spread="188.75"/>
                    <measurement group_id="O4" value="591.5" spread="302.96"/>
                    <measurement group_id="O5" value="904.6" spread="599.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 6 hours, n=16, 19, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.4" spread="12.32"/>
                    <measurement group_id="O2" value="100.6" spread="84.26"/>
                    <measurement group_id="O3" value="270.0" spread="169.37"/>
                    <measurement group_id="O4" value="371.5" spread="335.23"/>
                    <measurement group_id="O5" value="594.9" spread="525.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 8 hours, n=15, 19, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.1" spread="13.54"/>
                    <measurement group_id="O2" value="67.8" spread="61.02"/>
                    <measurement group_id="O3" value="213.8" spread="162.24"/>
                    <measurement group_id="O4" value="325.8" spread="359.79"/>
                    <measurement group_id="O5" value="428.2" spread="398.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 10 hours, n=16, 18, 22, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="22"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5" spread="67.85"/>
                    <measurement group_id="O2" value="61.5" spread="56.67"/>
                    <measurement group_id="O3" value="265.0" spread="396.25"/>
                    <measurement group_id="O4" value="274.5" spread="328.04"/>
                    <measurement group_id="O5" value="302.3" spread="255.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, 12 hours, n=16, 16, 21, 26, 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2" spread="174.14"/>
                    <measurement group_id="O2" value="74.7" spread="82.51"/>
                    <measurement group_id="O3" value="188.2" spread="188.27"/>
                    <measurement group_id="O4" value="232.8" spread="316.67"/>
                    <measurement group_id="O5" value="459.3" spread="561.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 56, Pre-dose, n=94, 91, 94, 95, 92</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="94"/>
                    <count group_id="O2" value="91"/>
                    <count group_id="O3" value="94"/>
                    <count group_id="O4" value="95"/>
                    <count group_id="O5" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.2" spread="73.19"/>
                    <measurement group_id="O2" value="91.8" spread="102.43"/>
                    <measurement group_id="O3" value="252.3" spread="295.15"/>
                    <measurement group_id="O4" value="372.1" spread="427.41"/>
                    <measurement group_id="O5" value="572.0" spread="738.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 84, Pre-dose, n=97, 94, 96, 91, 90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="97"/>
                    <count group_id="O2" value="94"/>
                    <count group_id="O3" value="96"/>
                    <count group_id="O4" value="91"/>
                    <count group_id="O5" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.2" spread="77.78"/>
                    <measurement group_id="O2" value="76.2" spread="106.86"/>
                    <measurement group_id="O3" value="212.3" spread="211.35"/>
                    <measurement group_id="O4" value="342.8" spread="411.28"/>
                    <measurement group_id="O5" value="484.3" spread="527.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, Pre-dose, n=92, 85, 89, 85, 84</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="85"/>
                    <count group_id="O3" value="89"/>
                    <count group_id="O4" value="85"/>
                    <count group_id="O5" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.2" spread="38.02"/>
                    <measurement group_id="O2" value="99.5" spread="138.00"/>
                    <measurement group_id="O3" value="217.9" spread="221.92"/>
                    <measurement group_id="O4" value="350.7" spread="336.07"/>
                    <measurement group_id="O5" value="459.5" spread="421.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, 0.5 hours, n=14, 12, 17, 18, 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.7" spread="91.51"/>
                    <measurement group_id="O2" value="248.3" spread="189.30"/>
                    <measurement group_id="O3" value="530.5" spread="536.75"/>
                    <measurement group_id="O4" value="1449.5" spread="949.00"/>
                    <measurement group_id="O5" value="1635.6" spread="1077.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, 1 hours, n=14, 13, 17, 18, 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162.1" spread="108.88"/>
                    <measurement group_id="O2" value="314.0" spread="157.04"/>
                    <measurement group_id="O3" value="681.2" spread="630.86"/>
                    <measurement group_id="O4" value="1590.3" spread="1019.32"/>
                    <measurement group_id="O5" value="1725.4" spread="870.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, 2 hours, n=14, 13, 17, 18, 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127.4" spread="88.80"/>
                    <measurement group_id="O2" value="331.9" spread="164.10"/>
                    <measurement group_id="O3" value="574.7" spread="445.85"/>
                    <measurement group_id="O4" value="1045.2" spread="414.21"/>
                    <measurement group_id="O5" value="1736.6" spread="592.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, 4 hours, n=13, 11, 16, 18, 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5" spread="53.67"/>
                    <measurement group_id="O2" value="190.9" spread="103.35"/>
                    <measurement group_id="O3" value="452.8" spread="289.44"/>
                    <measurement group_id="O4" value="805.0" spread="346.87"/>
                    <measurement group_id="O5" value="1459.9" spread="909.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, 6 hours, n=13, 13, 16, 18, 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" spread="26.36"/>
                    <measurement group_id="O2" value="135.5" spread="87.39"/>
                    <measurement group_id="O3" value="289.6" spread="188.04"/>
                    <measurement group_id="O4" value="554.8" spread="313.52"/>
                    <measurement group_id="O5" value="960.4" spread="633.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, 8 hours, n=13, 13, 17, 18, 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.5" spread="19.75"/>
                    <measurement group_id="O2" value="102.6" spread="60.14"/>
                    <measurement group_id="O3" value="245.1" spread="165.40"/>
                    <measurement group_id="O4" value="444.9" spread="298.69"/>
                    <measurement group_id="O5" value="760.8" spread="679.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, 10 hours, n=13, 12, 17, 18, 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.4" spread="35.98"/>
                    <measurement group_id="O2" value="76.6" spread="56.95"/>
                    <measurement group_id="O3" value="193.9" spread="128.42"/>
                    <measurement group_id="O4" value="380.2" spread="285.81"/>
                    <measurement group_id="O5" value="715.0" spread="840.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, 12 hours, n=13, 12, 17, 18, 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.2" spread="41.29"/>
                    <measurement group_id="O2" value="73.1" spread="41.21"/>
                    <measurement group_id="O3" value="169.7" spread="114.20"/>
                    <measurement group_id="O4" value="481.2" spread="640.17"/>
                    <measurement group_id="O5" value="662.4" spread="877.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot</title>
        <description>Blood samples were collected at indicated timepoints for the analysis of phamacokinetic parameter. All participants in the PK population who had at least 1 non-missing PK assessment obtained and analyzed whilst on treatment with danirixin from a dry blood spot sample and corresponding wet whole blood sample were included in Pharmacokinetic population.</description>
        <time_frame>Days 1 and 168</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot</title>
          <description>Blood samples were collected at indicated timepoints for the analysis of phamacokinetic parameter. All participants in the PK population who had at least 1 non-missing PK assessment obtained and analyzed whilst on treatment with danirixin from a dry blood spot sample and corresponding wet whole blood sample were included in Pharmacokinetic population.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Hour*nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="103"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="102"/>
                <count group_id="O5" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=17, 19, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="543.0" lower_limit="354.9" upper_limit="830.8"/>
                    <measurement group_id="O2" value="1373.1" lower_limit="1081.7" upper_limit="1743.0"/>
                    <measurement group_id="O3" value="3851.5" lower_limit="3136.7" upper_limit="4729.2"/>
                    <measurement group_id="O4" value="5485.1" lower_limit="4604.8" upper_limit="6533.8"/>
                    <measurement group_id="O5" value="8073.4" lower_limit="6591.3" upper_limit="9888.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=14, 13, 17, 18, 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="752.1" lower_limit="546.8" upper_limit="1034.4"/>
                    <measurement group_id="O2" value="1701.8" lower_limit="1257.2" upper_limit="2303.7"/>
                    <measurement group_id="O3" value="4170.1" lower_limit="3198.1" upper_limit="5437.6"/>
                    <measurement group_id="O4" value="7682.6" lower_limit="6384.8" upper_limit="9244.0"/>
                    <measurement group_id="O5" value="11538.0" lower_limit="9313.4" upper_limit="14294.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots</title>
        <description>Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.</description>
        <time_frame>Days 1 and 168</time_frame>
        <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
        <group_list>
          <group group_id="O1">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots</title>
          <description>Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.</description>
          <population>Pharmacokinetic Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).</population>
          <units>Nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="103"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="102"/>
                <count group_id="O5" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=17, 19, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164.9" lower_limit="119.5" upper_limit="227.5"/>
                    <measurement group_id="O2" value="343.1" lower_limit="264.1" upper_limit="445.6"/>
                    <measurement group_id="O3" value="1028.8" lower_limit="818.2" upper_limit="1293.7"/>
                    <measurement group_id="O4" value="1386.2" lower_limit="1172.1" upper_limit="1639.3"/>
                    <measurement group_id="O5" value="2119.1" lower_limit="1728.9" upper_limit="2597.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=14, 13, 17, 18, 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171.9" lower_limit="123.5" upper_limit="239.4"/>
                    <measurement group_id="O2" value="357.3" lower_limit="274.4" upper_limit="465.4"/>
                    <measurement group_id="O3" value="821.2" lower_limit="570.9" upper_limit="1181.2"/>
                    <measurement group_id="O4" value="1695.0" lower_limit="1285.8" upper_limit="2234.5"/>
                    <measurement group_id="O5" value="2390.5" lower_limit="2014.6" upper_limit="2836.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots</title>
        <description>Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.</description>
        <time_frame>Days 1 and 168</time_frame>
        <population>Pharmacokinetic Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Danirixin 5 mg</title>
            <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Danirixin 10 mg</title>
            <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Danirixin 25 mg</title>
            <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O4">
            <title>Danirixin 35 mg</title>
            <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
          <group group_id="O5">
            <title>Danirixin 50 mg</title>
            <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots</title>
          <description>Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.</description>
          <population>Pharmacokinetic Population.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="103"/>
                <count group_id="O3" value="102"/>
                <count group_id="O4" value="102"/>
                <count group_id="O5" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, n=17, 19, 24, 26, 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="24"/>
                    <count group_id="O4" value="26"/>
                    <count group_id="O5" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="0.58" upper_limit="11.80"/>
                    <measurement group_id="O2" value="1.000" lower_limit="0.50" upper_limit="12.00"/>
                    <measurement group_id="O3" value="1.000" lower_limit="0.50" upper_limit="10.08"/>
                    <measurement group_id="O4" value="1.000" lower_limit="0.48" upper_limit="5.85"/>
                    <measurement group_id="O5" value="1.000" lower_limit="0.50" upper_limit="12.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 168, n=14, 13, 17, 18, 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.000" lower_limit="0.50" upper_limit="11.78"/>
                    <measurement group_id="O2" value="1.000" lower_limit="0.50" upper_limit="2.00"/>
                    <measurement group_id="O3" value="1.000" lower_limit="0.33" upper_limit="10.00"/>
                    <measurement group_id="O4" value="1.000" lower_limit="0.48" upper_limit="11.87"/>
                    <measurement group_id="O5" value="1.542" lower_limit="0.50" upper_limit="11.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>On-treatment serious adverse events (SAEs) and non serious AEs were collected from the start of study treatment up to 196 days</time_frame>
      <desc>mITT population comprised of all randomized participants who were randomized apart from those randomized in error, received a treatment randomization number, modified and data for this population were based on actual treatment received. SAEs and AEs were reported for mITT Population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Danirixin 5 mg</title>
          <description>Participants received danirixin 5 milligram (mg) film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Danirixin 10 mg</title>
          <description>Participants received danirixin 10 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="E4">
          <title>Danirixin 25 mg</title>
          <description>Participants received danirixin 25 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="E5">
          <title>Danirixin 35 mg</title>
          <description>Participants received danirixin 35 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
        <group group_id="E6">
          <title>Danirixin 50 mg</title>
          <description>Participants received danirixin 50 mg film coated tablets orally twice daily with food and standard care of treatment for 24 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="103"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anal prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Gastrointestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pancreatitis chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Metapneumovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Perichondritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Psoas abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Ankylosing spondylitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Bladder papilloma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Cardiac neoplasm unspecified</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Oesophageal adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="103"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="103"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="103"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="102"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="103"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="103"/>
                <counts group_id="E5" subjects_affected="27" subjects_at_risk="102"/>
                <counts group_id="E6" subjects_affected="27" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="102"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="102"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="103"/>
                <counts group_id="E4" events="14" subjects_affected="12" subjects_at_risk="103"/>
                <counts group_id="E5" events="16" subjects_affected="14" subjects_at_risk="102"/>
                <counts group_id="E6" events="14" subjects_affected="10" subjects_at_risk="102"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="103"/>
                <counts group_id="E4" events="12" subjects_affected="9" subjects_at_risk="103"/>
                <counts group_id="E5" events="8" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E6" events="8" subjects_affected="6" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="102"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="103"/>
                <counts group_id="E4" events="7" subjects_affected="6" subjects_at_risk="103"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="102"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="102"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="103"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="103"/>
                <counts group_id="E5" events="9" subjects_affected="8" subjects_at_risk="102"/>
                <counts group_id="E6" events="8" subjects_affected="8" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

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


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03034967
org study id: 205724
secondary id: 2016-003675-21
nct id: NCT03034967
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Danirixin (DNX) is a selective CXC chemokine receptor (CXCR2) antagonist being developed as a
      potential anti-inflammatory agent for the treatment of COPD. This is a Phase 2, randomized,
      double-blind (Sponsor Open) study. The primary objective of the study is to evaluate the
      clinical activity and safety of danirixin compared with placebo in participants with COPD.
      Following baseline assessments collected over a 7 day period participants will be randomized
      (1:1:1:1:1:1) to receive one of five dose strengths of danirixin (5 milligram [mg], 10 mg, 25
      mg, 35 mg and 50 mg) or placebo. Study treatment will be administered orally twice daily for
      24 weeks. Participants will continue with their standard of care inhaled medications (i.e.
      long acting bronchodilators with or without inhaled corticosteroids) while receiving study
      treatment. Follow up will continue up to 28 days post last dose. Approximately 700
      participants will be screened with a target of 540 participants completing 24 weeks of
      treatment and key study assessments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in Respiratory Symptoms Measured by Evaluating Respiratory Symptoms (E-RS) in COPD. E-RS: COPD Total Score
time frame: Baseline and Month 6
description: E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms (RS)-breathlessness (RS-BRL comprised of 5 items, score range [0-17]), RS-cough and sputum (RS-CSP comprised of 3 items, score range [0-11]), and RS-chest symptoms (RS-CSY comprised of 3 items, score range [0-12]). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Per protocol population included all participants from the mITT population who did not have a protocol deviation considered to impact efficacy. Posterior mean change and standard deviation has been presented.
measure: Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Breathlessness Score)
time frame: Baseline and Month 6
description: E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
measure: Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Cough and Sputum Score)
time frame: Baseline and Month 6
description: E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
measure: Change From Baseline in Respiratory Symptoms Measured by E-RS in COPD (E-RS: COPD Chest Symptoms Score)
time frame: Baseline and Month 6
description: E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: RS-BRL comprised of 5 items, score range (0-17), RS-CSP comprised of 3 items, score range (0-11), and RS-CSY comprised of 3 items, score range (0-12). The total score ranged between 0-40 and higher values indicates severe respiratory symptoms. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
measure: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
time frame: Up to Day 196
description: AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
measure: Number of Participants With Worst Case Hematology Parameter Results by Potential Clinical Importance (PCI)
time frame: Up to Day 196
description: Blood samples were collected from participants for analysis of following hematology parameters with PCI low and high values: Basophils % (High 5.00x), Eosinophils % (High 2.00x), Mean corpuscular hemoglobin concentration (MCHC) gram per deciliter (g/dL) (Low 0.85x, high 1.10x), Mean corpuscular hemoglobin (MCH) picograms (pg) (Low 0.85x, high 1.20x), Mean corpuscular volume (MCV) femtoliter (fL) (low 0.25x, high 2.00x), Erythrocytes (Ery.)(10^12cells/L) (Low 0.93x, high 1.07x), Hematocrit (Ratio of 1) (Low 0.50x, high 0.50x), Hemoglobin gram per liter (g/L) (Low 0.85x, high 1.20x), Leukocytes (x10^9/L) (Low 0.70x, high 1.60x), Lymphocytes % (Low 0.80x, high 1.20x), Monocytes % (Low 0.80x, high 1.60x), Neutrophils % (Low 0.65x, high 1.50x), Platelets (x10^9cells/L) (Low 0.90x, high 1.10x). Multipliers are identified by "x", otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.
measure: Number of Participants With Worst Case Clinical Chemistry Parameter Results by PCI
time frame: Up to Day 196
description: Blood samples were collected from participants for analysis of following chemistry parameters with PCI low and high values: Alanine aminotransferase (ALT) International units per liter (IU/L) (High => 3x ULN), Alkaline phosphatase (ALP) (IU/L) (High ≥ 2x ULN); Aspartate aminotransferase (AST) (IU/L) (High=> 3x ULN); Bilirubin micromole per liter (umol/L) (High ≥ 2x ULN); Calcium millimole per liter (mmol/L) (Low 0.85x, high 1.08x), Chloride (mmol/L) (Low 0.90x, high 1.10x), Creatinine (umol/L) (High 1.30x), Direct bilirubin (umol/L) (High ≥ 2x ULN), Glucose (mmol/L) (Low <0.6x, high >4x), Potassium (mmol/L) (Low 0.75x, high 1.30x); Protein (g/L) (High 1.25x), Sodium (mmol/L) (Low 0.80x, high 1.15x), Multipliers are identified by "x", otherwise actual comparison values are provided with units. Values above and below this range were considered of PCI.
measure: Number of Participants With Worst Case Vital Signs Parameter Results by PCI
time frame: Up to Day 168
description: Vital signs parameters includes systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse rate and respiration rate were measured in a semi-supine position after 5 minutes rest for the participants at indicated time points. PCI ranges for vital signs parameters were as follows: <90 to >160 millimeters of mercury (mmHg) for SBP and <40 to >110 mmHg for DBP, <35 or >120 beats per minute for heart rate and <8 or >30 breaths per minute for respiration rate. Values above and below this range were considered of PCI.
measure: Number of Participants With Worst Case Post-Baseline Abnormal 12-lead Electrocardiogram (ECG) Findings
time frame: Baseline and Day 168
description: Triplicate 12-lead ECG obtained to measure PR, QRS, QT, and Corrected QT intervals. Only those participants with worst case post-Baseline data have been represented for abnormal - not clinical significant and abnormal - clinical significant. Day 1 was considered as Baseline.
measure: Number of Moderate or Severe Healthcare Resource Utilization (HCRU) Exacerbations Per Participant
time frame: Up to Day 196
description: Participants with moderate or severe COPD exacerbations, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness analyzed. Mild exacerbations are defined as exacerbations that did not require treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, Emergency Room [ER] visit or resulting in death). Moderate exacerbations are defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization, ER visit or resulting in death). Severe exacerbations are defined as exacerbations that required hospitalization, ER visit or resulted in death. Number of moderate or severe HCRU exacerbations per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and >=2= participants in each treatment group who experienced 2 or more events.
measure: Number of Responders E-RS in COPD (E-RS): COPD Total Score
time frame: Month 6
description: E-RS: COPD is a subset of EXACT. E-RS is a tool that consists of 11 items from the 14 item EXACT instrument. E-RS is intended to capture information related to the respiratory symptoms of COPD, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS has a scoring range of 0-40; higher scores indicate more severe symptoms. Response is defined as an E-RS: COPD total score of 2 units below baseline or lower. Non-response is defined as an E-RS: COPD total score higher than 2 units below Baseline.
measure: Number of EXACT Events Per Participant
time frame: Up to Day 196
description: EXACT is a 14 item patient reported outcome (PRO) instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Events were categorized as recovered, censored, or persistent worsening. Number of EXACT events per participant has been presented, where 0= participants in each treatment group who did not experience an event; 1= participants in each treatment group who experienced 1 event and >=2= participants in each treatment group who experienced 2 or more events.
measure: Time to First EXACT Event
time frame: Up to Day 168
description: The time to first on-treatment EXACT event was calculated as the onset date of the first on-treatment EXACT event minus date of start of treatment plus 1.
measure: Severity of EXACT Event
time frame: Up to Day 168
description: EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery.
measure: EXACT Event Duration for All Events
time frame: Up to Day 168
description: EXACT is a 14 item PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in participants with COPD. The total score for EXACT-PRO ranges from 0-100, higher scores indicate more severe symptoms. Severity is the highest EXACT total score during the period from onset to recovery. Duration of EXACT events has been reported.
measure: Time to First HCRU-defined COPD Exacerbation
time frame: Up to Day 196
description: The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.
measure: Time to First Severe HCRU-defined COPD Exacerbation
time frame: Up to Day 196
description: A COPD exacerbation defined as a severe exacerbation if it requires hospitalization or ER visit or extended observation. The time to first on-treatment Moderate/Severe HCRU exacerbation was calculated as exacerbation onset date of first on-treatment moderate or severe on-treatment exacerbation - date of start of treatment +1.
measure: HCRU-defined Exacerbation Duration
time frame: Up to Day 196
description: The duration of HCRU exacerbation were determined. The duration of the exacerbation was calculated as (exacerbation resolution date or date of death - exacerbation onset date + 1). For exacerbations which were not resolved but where the participant later died from other causes, the duration was calculated using date of death as the end date of the event.
measure: Change From Baseline in St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Total Score
time frame: Baseline, Days 84 and 168
description: The SGRQ-C consists of 40 items aggregated into 3 component scores: Symptoms, Activity, Impacts, and a Total score. Each response to a question is assigned a weight. Component scores are calculated by summing the weights from all positive items in that component, dividing by the sum of weights for all items in that component, and multiplying this number by 100. Component scores could range from 0-100, with a higher component score indicating greater disease burden. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
measure: Number of SGRQ Responder
time frame: Day 84 and Day 168
description: A participant was consider Responder according to SGRQ total score if their change from Baseline SGRQ total score of 4 units below Baseline or lower.
measure: Change From Baseline COPD Assessment Test (CAT) Total Score
time frame: Baseline, Days 84 and 168
description: The CAT is an 8 item questionnaire (cough, sputum, chest tightness, breathlessness, going up hills/stairs, activity limitation at home, confidence leaving the home, and sleep and energy) that measures health status of participants with COPD. Participants were completed each question by rating their experience on a 6 point scale ranging from 0 (maximum impairment) to 5 (no impairment) with a total scoring range of 0-40; higher scores indicate worse health status. A CAT score was calculated by summing the non-missing scores on the eight items. Individual items are scored from 0 to 5 with a total score range from 0 - 40, higher scores indicate greater disease impact. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Posterior mean change and standard deviation has been presented.
measure: Number of CAT Responder
time frame: Day 84 and Day 168
description: A participant was considered as a responder according to CAT score if their change from Baseline CAT score 2.0 units below Baseline or lower.
measure: Change From Baseline in Post-bronchodilator FEV1 as a Lung Function Assessment
time frame: Baseline, Days 84 and 168
description: Spirometric analysis was done to determine FEV1. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.
measure: Percent Predicted Normal FEV1
time frame: At Screening
description: Spirometric analysis was done to determine percent predicted FEVI at screening. FEV1 is forced expiratory volume in one second. Percent predicted FEV1 is defined as the percent FEV1 of the participant is divided by average FEV1 percent in the population of any person similar age, sex and body composition.
measure: Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC) as a Lung Function Assessment
time frame: Baseline, Days 84 and 168
description: Spirometric analysis was done to determine FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.
measure: Change From Baseline in Post-bronchodilator FEV1/FVC Ratio as a Lung Function Assessment
time frame: Baseline, Days 84 and 168
description: Spirometric analysis was done to determine FEV1 and FVC. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value.
measure: Change From Baseline Number of Puffs of Rescue Medication Per Day
time frame: Baseline, Months 1, 2, 3, 4, 5 and 6
description: The mean number of puffs of rescue per day was calculated over the same time periods and using the same assumptions as rescue use via diary. Day 1 was considered as Baseline. Change from Baseline was calculated by subtracting Baseline value from the specified time point value. Least square mean change from Baseline and standard error has been presented.
measure: Participant Experience of Physical Activity Measured Using PROactive Physical Activity in COPD (C-PPAC) Questionnaire
time frame: Days 84 and 168
description: The Clinical Visit PROactive Physical Activity in COPD (C-PPAC) tool is a designed for intermittent use within a clinical study. PROactive Total Score and two domain scores (amount and difficulty) are derived using data from the C-PPAC questionnaire and a physical activity monitor worn for 7 days prior to the questionnaire.C-PPAC is a 12 item questionnaire. The PROactive tools are scored from 0 to 100 with higher scores indicating greater disease impact. It was implemented in a subset of approximately 50% of participants. The amount domain is calculated using 2 items from the C-PPAC questionnaire (amount of walking outside and chores outside) and 2 activity monitor outputs (vector magnitude units per minute (VMU/min) and steps/day). Each domain score is based on the addition of items (0-15 for amount and 0-40 for difficulty) and then scaled from 0-100. The total score is calculated as (amount+difficulty)/2.
measure: Danirixin Whole Blood Pharmacokinetic Concentration-Time Data
time frame: Pre-dose on Days 1, 56, 84 and 168; 0.5, 1, 2, 4, 6, 8, 10, 12 hours post-dose on Days 1 and 168
description: Blood samples were collected from the participants for the analysis of blood pharmacokinetic concentration-time data. All participants in the mITT population who had at least 1 non-missing Pharmacokinetic assessment obtained and analyzed whilst on treatment with danirixin were included Pharmacokinetic population.
measure: Area Under the Plasma Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration [AUC(0-t)] of Danirixin in Whole Blood Using Dried Blood Spot
time frame: Days 1 and 168
description: Blood samples were collected at indicated timepoints for the analysis of phamacokinetic parameter. All participants in the PK population who had at least 1 non-missing PK assessment obtained and analyzed whilst on treatment with danirixin from a dry blood spot sample and corresponding wet whole blood sample were included in Pharmacokinetic population.
measure: Concentration Maximum (Cmax) of Danirixin in Whole Blood Using Dried Blood Spots
time frame: Days 1 and 168
description: Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Danirixin in Whole Blood Using Dried Blood Spots
time frame: Days 1 and 168
description: Blood samples were collected from the participants for the analysis of pharmacokinetic parameter.
arm group label: Danirixin 5 mg
arm group type: Experimental
description: Eligible participants will receive danirixin 5 mg tablet with food twice daily along with standard care of treatment for 24 weeks.
arm group label: Danirixin 10 mg
arm group type: Experimental
description: Eligible participants will receive danirixin 10 mg tablet with food twice daily along with standard care of treatment for 24 weeks.
arm group label: Danirixin 25 mg
arm group type: Experimental
description: Eligible participants will receive danirixin 25 mg tablet with food twice daily along with standard care of treatment for 24 weeks.
arm group label: Danirixin 35 mg
arm group type: Experimental
description: Eligible participants will receive danirixin 35 mg tablet with food twice daily along with standard care of treatment for 24 weeks.
arm group label: Danirixin 50 mg
arm group type: Experimental
description: Eligible participants will receive danirixin 50 mg tablet with food twice daily along with standard care of treatment for 24 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Eligible participants will receive placebo tablet with food twice daily along with standard care of treatment for 24 weeks.
intervention type: Drug
intervention name: Danirixin
description: Danirixin is available as 5, 10, 25, 35 and 50 mg white, film-coated, oval or round shaped tablets for oral administration.
arm group label: Danirixin 10 mg
arm group label: Danirixin 25 mg
arm group label: Danirixin 35 mg
arm group label: Danirixin 5 mg
arm group label: Danirixin 50 mg
intervention type: Drug
intervention name: Danirixin matching placebo
description: Danirixin matching placebo will be available as white, film-coated, oval or round shaped tablets for oral administration.
arm group label: Placebo
intervention type: Drug
intervention name: Standard of care
description: Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) during the study treatment.
arm group label: Danirixin 10 mg
arm group label: Danirixin 25 mg
arm group label: Danirixin 35 mg
arm group label: Danirixin 5 mg
arm group label: Danirixin 50 mg
arm group label: Placebo
intervention type: Drug
intervention name: Rescue medication
description: Participants will continue to use rescue medication(s). The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.
arm group label: Danirixin 10 mg
arm group label: Danirixin 25 mg
arm group label: Danirixin 35 mg
arm group label: Danirixin 5 mg
arm group label: Danirixin 50 mg
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Australia
country: Canada
country: Germany
country: Korea, Republic of
country: Netherlands
country: Poland
country: Romania
country: Spain
country: United States
citation: Lazaar AL, Miller BE, Donald AC, Keeley T, Ambery C, Russell J, Watz H, Tal-Singer R; for 205724 Investigators. CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial. Respir Res. 2020 Jun 12;21(1):149. doi: 10.1186/s12931-020-01401-4.
PMID: 32532258
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Yes
ipd description: IPD for this study is available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: https://www.clinicalstudydatarequest.com/Posting.aspx?ID=20593
provided document: 
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reported events: 
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point of contact: 