<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/NCT02993822</url>
  </required_header>
  <id_info>
    <org_study_id>VOLCANO-2</org_study_id>
    <nct_id>NCT02993822</nct_id>
  </id_info>
  <brief_title>A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough</brief_title>
  <official_title>A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nerre Therapeutics Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nerre Therapeutics Ltd.</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>
      The purpose of this study is to determine the effectiveness of three doses of orvepitant,&#xD;
      taken once a day, in the treatment of chronic refractory cough.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study&#xD;
      in subjects with chronic refractory cough (CRC).&#xD;
&#xD;
      Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in&#xD;
      four parallel groups.&#xD;
&#xD;
      Each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately&#xD;
      292 subjects in total).&#xD;
&#xD;
      All subjects will enter a three-week screening period to determine eligibility. Eligible&#xD;
      subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind&#xD;
      dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There&#xD;
      will be a final safety follow-up visit at Week 14.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Actual">January 24, 2019</completion_date>
  <primary_completion_date type="Actual">January 14, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Week 12 in Awake Objective Cough Frequency</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline</measure>
    <time_frame>Week 4</time_frame>
    <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change in Cough Frequency at Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change in Cough Frequency at Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change in Cough Frequency at Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change in Cough Frequency at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change in Cough Severity at Week 2</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change in Cough Severity at Week 4</measure>
    <time_frame>Baseline to Week 4</time_frame>
    <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change in Cough Severity at Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change in Cough Severity at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">315</enrollment>
  <condition>Chronic Refractory Cough</condition>
  <arm_group>
    <arm_group_label>Orvepitant 10mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orvepitant 10mg tablet, once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orvepitant 20mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orvepitant 20mg tablet, once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orvepitant 30mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orvepitant 30mg tablet, once daily for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo to match tablet, once daily for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Orvepitant Maleate</intervention_name>
    <description>Tablet, once daily, oral</description>
    <arm_group_label>Orvepitant 10mg</arm_group_label>
    <arm_group_label>Orvepitant 20mg</arm_group_label>
    <arm_group_label>Orvepitant 30mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tablet, once daily, oral</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects ≥18 years of age.&#xD;
&#xD;
          -  Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines&#xD;
             attached).&#xD;
&#xD;
          -  An awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during&#xD;
             the screening period.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with respiratory tract infection (&lt;4 weeks prior to study start)&#xD;
&#xD;
          -  Current smokers or ex-smokers with &lt;6 months' abstinence or cumulative history of &gt;10&#xD;
             pack years&#xD;
&#xD;
          -  Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of&#xD;
             screening&#xD;
&#xD;
          -  FEV1 &lt;80% predicted, measured at screening using spirometry&#xD;
&#xD;
          -  History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant&#xD;
             bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease&#xD;
             (COPD)&#xD;
&#xD;
          -  Any clinically significant abnormal laboratory test result(s)&#xD;
&#xD;
          -  Inability to comply with the use of prohibited and allowed medications as described in&#xD;
             the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Study Site 15</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 43</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 52</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92692</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 20</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 28</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 25</name>
      <address>
        <city>Centennial</city>
        <state>Colorado</state>
        <zip>80112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 36</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 48</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 68</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 59</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 12</name>
      <address>
        <city>Largo</city>
        <state>Florida</state>
        <zip>33778</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 62</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 57</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33186</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 33</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 11</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 60</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 39</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 34</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 42</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 41</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 37</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 27</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 16</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 32</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 55</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 24</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 53</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>29732</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 50</name>
      <address>
        <city>Gastonia</city>
        <state>North Carolina</state>
        <zip>28054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 54</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 73</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 71</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 56</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 74</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 26</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 38</name>
      <address>
        <city>East Providence</city>
        <state>Rhode Island</state>
        <zip>02914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 21</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 72</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 22</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 35</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 10</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 49</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 23</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 58</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 19</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 14</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 13</name>
      <address>
        <city>Greenfield</city>
        <state>Wisconsin</state>
        <zip>53228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 66</name>
      <address>
        <city>Niagara Falls</city>
        <state>Ontario</state>
        <zip>L2G 1J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 65</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 4W2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 64</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <zip>G8T 7A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 29</name>
      <address>
        <city>Romford</city>
        <state>Essex</state>
        <zip>RM1 3PJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 94</name>
      <address>
        <city>Blackpool</city>
        <state>Lancashire</state>
        <zip>FY2 0JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 93</name>
      <address>
        <city>Prescot</city>
        <state>Merseyside</state>
        <zip>L34 1BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 17</name>
      <address>
        <city>Northwood</city>
        <state>Middlesex</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 40</name>
      <address>
        <city>Belfast</city>
        <state>Northern Ireland</state>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 96</name>
      <address>
        <city>Barnsley</city>
        <state>South Yorkshire</state>
        <zip>S75 3DL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 97</name>
      <address>
        <city>Cannock</city>
        <state>Staffordshire</state>
        <zip>WS11 0BN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 95</name>
      <address>
        <city>Stockton-on-Tees</city>
        <state>Teesside</state>
        <zip>TS17 6EW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 45</name>
      <address>
        <city>Hull</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 92</name>
      <address>
        <city>Leeds</city>
        <zip>LS10 1DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 30</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 46</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 91</name>
      <address>
        <city>Manchester</city>
        <zip>M32 0UT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 18</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 47</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site 31</name>
      <address>
        <city>North Shields</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Study Site44</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>February 18, 2022</results_first_submitted>
  <results_first_submitted_qc>March 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 26, 2022</results_first_posted>
  <disposition_first_submitted>March 6, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>March 31, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">April 26, 2022</disposition_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cough</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maleic acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 21, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02993822/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT02993822/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The first subject was enrolled (screened and consented) on 22-May-2017; the first subject was randomised on 31-Jan-2017. The last subject was enrolled on 28-Sep-2018. The last subject last visit (study completion) was 24-Jan-2019.&#xD;
Subjects were recruited from a mixture of specialised standalone clinics and clinics within hospitals.</recruitment_details>
      <pre_assignment_details>Screening details:&#xD;
488 subjects were screened, of whom 315 (64.5%) completed screening and were randomised.&#xD;
Screening failures occurred due to not meeting inclusion criteria (74 subjects [15.2%]) or exclusion criteria (79 subjects [16.2%]), withdrawal of consent (nine [1.8%] subjects) and AEs (2 [0.4%] subjects). All other reasons reported in individual subjects.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Orvepitant 10mg</title>
          <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="P2">
          <title>Orvepitant 20mg</title>
          <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="P3">
          <title>Orvepitant 30mg</title>
          <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="P4">
          <title>Placebo</title>
          <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="79"/>
                <participants group_id="P4" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
                <participants group_id="P2" count="74"/>
                <participants group_id="P3" count="69"/>
                <participants group_id="P4" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" 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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unable to attend follow-up due to illness</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Orvepitant 10mg</title>
          <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="B2">
          <title>Orvepitant 20mg</title>
          <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="B3">
          <title>Orvepitant 30mg</title>
          <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="B4">
          <title>Placebo</title>
          <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
        </group>
        <group group_id="B5">
          <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="79"/>
            <count group_id="B2" value="78"/>
            <count group_id="B3" value="79"/>
            <count group_id="B4" value="79"/>
            <count group_id="B5" value="315"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="37"/>
                    <measurement group_id="B5" value="183"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="62.29" spread="9.850"/>
                    <measurement group_id="B2" value="59.86" spread="13.173"/>
                    <measurement group_id="B3" value="59.47" spread="10.020"/>
                    <measurement group_id="B4" value="62.24" spread="11.815"/>
                    <measurement group_id="B5" value="60.97" spread="11.313"/>
                  </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="65"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="60"/>
                    <measurement group_id="B4" value="59"/>
                    <measurement group_id="B5" value="253"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="77"/>
                    <measurement group_id="B4" value="74"/>
                    <measurement group_id="B5" value="299"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>North America</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="51"/>
                    <measurement group_id="B5" value="202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Europe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="28"/>
                    <measurement group_id="B5" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Week 12 in Awake Objective Cough Frequency</title>
        <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Week 12 in Awake Objective Cough Frequency</title>
          <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>coughs per hour (log transformed)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="72"/>
                <count group_id="O3" value="67"/>
                <count group_id="O4" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.185" spread="0.3258"/>
                    <measurement group_id="O2" value="-0.192" spread="0.3405"/>
                    <measurement group_id="O3" value="-0.271" spread="0.4055"/>
                    <measurement group_id="O4" value="-0.243" spread="0.3225"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.324</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.332</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.531</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline</title>
        <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline</title>
          <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>coughs per hour (log transformed)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.180" spread="0.2791"/>
                    <measurement group_id="O2" value="-0.181" spread="0.3142"/>
                    <measurement group_id="O3" value="-0.215" spread="0.2515"/>
                    <measurement group_id="O4" value="-0.139" spread="0.2892"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.482</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.460</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.75</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.144</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline</title>
        <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
        <time_frame>Week 4</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline</title>
          <description>Objective cough frequency measured by ambulatory cough monitoring device</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>coughs per hour (log transformed)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.188" spread="0.3292"/>
                    <measurement group_id="O2" value="-0.231" spread="0.3665"/>
                    <measurement group_id="O3" value="-0.211" spread="0.2994"/>
                    <measurement group_id="O4" value="-0.169" spread="0.2699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.992</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.387</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.71</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change from baseline to each visit (Week 2, Week 4 and Week 12) in log transformed awake objective cough frequency was analysed using a mixed model for repeated measures (MMRM) with restricted maximum likelihood (REML) estimation. The treatment effect at Week 12 was estimated using the ratio of geometric means (i.e. the difference between the treatments least squares means [adjusted means] on the log scale, back transformed to the original scale).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.600</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.74</ci_lower_limit>
            <ci_upper_limit>1.19</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline</title>
        <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline</title>
          <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.41" spread="3.309"/>
                    <measurement group_id="O2" value="2.37" spread="3.252"/>
                    <measurement group_id="O3" value="2.93" spread="3.010"/>
                    <measurement group_id="O4" value="1.24" spread="2.714"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.042</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.5</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline</title>
        <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline</title>
          <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="3.416"/>
                    <measurement group_id="O2" value="2.15" spread="3.490"/>
                    <measurement group_id="O3" value="2.98" spread="3.163"/>
                    <measurement group_id="O4" value="1.61" spread="3.132"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.250</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.4</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.325</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.029</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline</title>
        <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline</title>
          <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="70"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.78" spread="3.535"/>
                    <measurement group_id="O2" value="2.19" spread="3.602"/>
                    <measurement group_id="O3" value="2.82" spread="3.960"/>
                    <measurement group_id="O4" value="1.34" spread="3.222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.038</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.1</ci_lower_limit>
            <ci_upper_limit>2.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.118</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.2</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.025</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline</title>
        <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline</title>
          <description>The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Total score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="67"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.38" spread="3.609"/>
                    <measurement group_id="O2" value="2.09" spread="3.736"/>
                    <measurement group_id="O3" value="3.23" spread="4.007"/>
                    <measurement group_id="O4" value="1.50" spread="3.586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.258</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>1.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.243</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.5</ci_lower_limit>
            <ci_upper_limit>1.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The change from baseline in LCQ total score and the three domain scores was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline.&#xD;
The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in LCQ total score and the three domain scores was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.4</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time</title>
        <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time</title>
          <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.7" spread="26.06"/>
                    <measurement group_id="O2" value="-10.5" spread="27.78"/>
                    <measurement group_id="O3" value="-13.5" spread="22.93"/>
                    <measurement group_id="O4" value="-6.3" spread="19.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-9.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.6</ci_lower_limit>
            <ci_upper_limit>-2.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.198</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.4</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.055</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.7</ci_lower_limit>
            <ci_upper_limit>0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time</title>
        <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time</title>
          <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.9" spread="27.11"/>
                    <measurement group_id="O2" value="-9.4" spread="26.76"/>
                    <measurement group_id="O3" value="-15.9" spread="25.02"/>
                    <measurement group_id="O4" value="-7.8" spread="22.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.3</ci_lower_limit>
            <ci_upper_limit>-1.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.571</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.6</ci_lower_limit>
            <ci_upper_limit>5.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.043</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.2</ci_lower_limit>
            <ci_upper_limit>-0.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time</title>
        <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time</title>
          <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.0" spread="30.37"/>
                    <measurement group_id="O2" value="-9.9" spread="29.57"/>
                    <measurement group_id="O3" value="-18.6" spread="27.24"/>
                    <measurement group_id="O4" value="-8.2" spread="23.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.7</ci_lower_limit>
            <ci_upper_limit>-3.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.435</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.1</ci_lower_limit>
            <ci_upper_limit>4.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-9.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.4</ci_lower_limit>
            <ci_upper_limit>-1.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time</title>
        <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time</title>
          <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.8" spread="31.27"/>
                    <measurement group_id="O2" value="-11.6" spread="27.33"/>
                    <measurement group_id="O3" value="-20.1" spread="29.33"/>
                    <measurement group_id="O4" value="-10.6" spread="24.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.103</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.3</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.546</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.6</ci_lower_limit>
            <ci_upper_limit>5.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.034</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-9.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.2</ci_lower_limit>
            <ci_upper_limit>-0.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time</title>
        <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time</title>
          <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="71"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.8" spread="28.96"/>
                    <measurement group_id="O2" value="-7.8" spread="26.76"/>
                    <measurement group_id="O3" value="-6.2" spread="24.97"/>
                    <measurement group_id="O4" value="-3.9" spread="27.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.8</ci_lower_limit>
            <ci_upper_limit>-3.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.282</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.5</ci_lower_limit>
            <ci_upper_limit>3.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.398</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.7</ci_lower_limit>
            <ci_upper_limit>4.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time</title>
        <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time</title>
          <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="32.87"/>
                    <measurement group_id="O2" value="-7.9" spread="27.52"/>
                    <measurement group_id="O3" value="-5.8" spread="27.96"/>
                    <measurement group_id="O4" value="-2.7" spread="27.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.019</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.3</ci_lower_limit>
            <ci_upper_limit>-1.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.170</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.7</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.384</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.7</ci_lower_limit>
            <ci_upper_limit>4.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time</title>
        <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time</title>
          <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.5" spread="32.65"/>
                    <measurement group_id="O2" value="-6.8" spread="29.07"/>
                    <measurement group_id="O3" value="-9.8" spread="28.73"/>
                    <measurement group_id="O4" value="-2.2" spread="28.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.0</ci_lower_limit>
            <ci_upper_limit>-3.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.222</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.0</ci_lower_limit>
            <ci_upper_limit>3.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.058</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-7.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.0</ci_lower_limit>
            <ci_upper_limit>0.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time</title>
        <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time</title>
          <description>The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from &quot;no cough&quot; (0 mm) on the left to &quot;worst cough&quot; (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.9" spread="35.99"/>
                    <measurement group_id="O2" value="-7.1" spread="26.88"/>
                    <measurement group_id="O3" value="-9.6" spread="30.24"/>
                    <measurement group_id="O4" value="-1.5" spread="33.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.027</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.9</ci_lower_limit>
            <ci_upper_limit>-1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.147</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.9</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the Cough Severity VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in Cough Severity VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.046</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.6</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline</title>
        <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline</title>
          <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.8" spread="24.59"/>
                    <measurement group_id="O2" value="-12.0" spread="25.09"/>
                    <measurement group_id="O3" value="-13.8" spread="22.03"/>
                    <measurement group_id="O4" value="-7.0" spread="20.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-12.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.5</ci_lower_limit>
            <ci_upper_limit>-5.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.114</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-5.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.4</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.056</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.7</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline</title>
        <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline</title>
          <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="75"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.0" spread="26.93"/>
                    <measurement group_id="O2" value="-12.0" spread="26.67"/>
                    <measurement group_id="O3" value="-17.3" spread="24.73"/>
                    <measurement group_id="O4" value="-8.8" spread="24.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.027</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.8</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.357</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-3.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.3</ci_lower_limit>
            <ci_upper_limit>4.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.031</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.2</ci_lower_limit>
            <ci_upper_limit>-0.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline</title>
        <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline</title>
          <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.8" spread="28.00"/>
                    <measurement group_id="O2" value="-14.5" spread="27.55"/>
                    <measurement group_id="O3" value="-19.7" spread="26.80"/>
                    <measurement group_id="O4" value="-11.0" spread="24.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.2</ci_lower_limit>
            <ci_upper_limit>-2.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.321</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-4.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.8</ci_lower_limit>
            <ci_upper_limit>3.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.047</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-8.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.0</ci_lower_limit>
            <ci_upper_limit>-0.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline</title>
        <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline</title>
          <description>The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from &quot;no urge to cough&quot; (0 mm) on the left to &quot;severe urge to cough&quot; (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
          <units>Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="68"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.7" spread="27.30"/>
                    <measurement group_id="O2" value="-12.6" spread="28.57"/>
                    <measurement group_id="O3" value="-22.9" spread="28.43"/>
                    <measurement group_id="O4" value="-11.8" spread="26.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.018</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.4</ci_lower_limit>
            <ci_upper_limit>-1.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.682</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.8</ci_lower_limit>
            <ci_upper_limit>6.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Change in the urge-to-cough VAS was summarised by treatment group and visit (Weeks 2, 4, 8 and 12) in terms of absolute values and changes from baseline. The effect of treatment in terms of the change from baseline to each scheduled visit (Week 2, Week 4, Week 8 and Week 12) in urge-to cough VAS was analysed using a MMRM with REML estimation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>Mixed model repeated measures</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-11.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.0</ci_lower_limit>
            <ci_upper_limit>-3.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Rating of Change in Cough Frequency at Week 2</title>
        <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Global Rating of Change in Cough Frequency at Week 2</title>
          <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</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="73"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="34"/>
                    <measurement group_id="O4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.134</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Rating of Change in Cough Frequency at Week 4</title>
        <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Global Rating of Change in Cough Frequency at Week 4</title>
          <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</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="69"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.401</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.175</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.126</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Rating of Change in Cough Frequency at Week 8</title>
        <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Global Rating of Change in Cough Frequency at Week 8</title>
          <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</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="67"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.144</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.025</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Rating of Change in Cough Frequency at Week 12</title>
        <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Global Rating of Change in Cough Frequency at Week 12</title>
          <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</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="67"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="67"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.158</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.597</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.124</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Rating of Change in Cough Severity at Week 2</title>
        <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Global Rating of Change in Cough Severity at Week 2</title>
          <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</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="73"/>
                <count group_id="O2" value="77"/>
                <count group_id="O3" value="76"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="39"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="37"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.01</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.049</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Rating of Change in Cough Severity at Week 4</title>
        <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 4</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Global Rating of Change in Cough Severity at Week 4</title>
          <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</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="69"/>
                <count group_id="O2" value="76"/>
                <count group_id="O3" value="74"/>
                <count group_id="O4" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="36"/>
                    <measurement group_id="O4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.309</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.387</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.025</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Rating of Change in Cough Severity at Week 8</title>
        <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Global Rating of Change in Cough Severity at Week 8</title>
          <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</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="67"/>
                <count group_id="O2" value="75"/>
                <count group_id="O3" value="72"/>
                <count group_id="O4" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="36"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.003</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.152</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Rating of Change in Cough Severity at Week 12</title>
        <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</population>
        <group_list>
          <group group_id="O1">
            <title>Orvepitant 10mg</title>
            <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O2">
            <title>Orvepitant 20mg</title>
            <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O3">
            <title>Orvepitant 30mg</title>
            <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
          </group>
          <group group_id="O4">
            <title>Placebo</title>
            <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
          </group>
        </group_list>
        <measure>
          <title>Global Rating of Change in Cough Severity at Week 12</title>
          <description>In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with &quot;worse&quot;, &quot;about the same&quot; or &quot;better&quot;. If subjects indicated a change (either &quot;worse&quot; or &quot;better&quot;) they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.</description>
          <population>The number of participants analyzed differs from the overall subject disposition as it includes only participants with data available for the comparison (i.e. some participants have missing data).</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="67"/>
                <count group_id="O2" value="74"/>
                <count group_id="O3" value="67"/>
                <count group_id="O4" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>About the same</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Better</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.100</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.557</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The Global Rating of Change responses were summarised by treatment group and visit (Weeks 2, 4, 8 and 12) as categorical endpoints (&quot;worse&quot;, &quot;about the same&quot; and &quot;better&quot;). Pairwise comparisons were performed using the Cochran Mantel Haenszel test stratified by region using modified ridit scores (row mean scores differ).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.054</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were reported for each participant from the time of consent up until the last visit (follow-up or early withdrawal). For each completed participant this was a period of 17 weeks.</time_frame>
      <desc>Adverse events could be volunteered spontaneously by the subject, or were discovered as a result of general, non leading questioning. Note: The adverse events posted in ClinicalTrials.gov results are treatment-emergent adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Orvepitant 10mg</title>
          <description>Orvepitant 10mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="E2">
          <title>Orvepitant 20mg</title>
          <description>Orvepitant 20mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="E3">
          <title>Orvepitant 30mg</title>
          <description>Orvepitant 30mg tablet, once daily for 12 weeks&#xD;
Orvepitant Maleate: Tablet, once daily, oral</description>
        </group>
        <group group_id="E4">
          <title>Placebo</title>
          <description>Placebo to match tablet, once daily for 12 weeks&#xD;
Placebo: Tablet, once daily, oral</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Non-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="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Intestinal anastomosis complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Non-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="63" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="53" subjects_at_risk="79"/>
                <counts group_id="E4" subjects_affected="40" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="79"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="78"/>
                <counts group_id="E3" events="11" subjects_affected="11" subjects_at_risk="79"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="79"/>
                <counts group_id="E2" events="10" subjects_affected="7" subjects_at_risk="78"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E4" events="9" subjects_affected="9" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="79"/>
              </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="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E2" events="19" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Stephen Pawsey</name_or_title>
      <organization>NeRRe Therapeutics Limited</organization>
      <phone>+44 (0)1438906960</phone>
      <email>steve.pawsey@nerretherapeutics.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/NCT02993822
org study id: VOLCANO-2
nct id: NCT02993822
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine the effectiveness of three doses of orvepitant,
      taken once a day, in the treatment of chronic refractory cough.
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study
      in subjects with chronic refractory cough (CRC).

      Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in
      four parallel groups.

      Each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately
      292 subjects in total).

      All subjects will enter a three-week screening period to determine eligibility. Eligible
      subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind
      dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There
      will be a final safety follow-up visit at Week 14.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline to Week 12 in Awake Objective Cough Frequency
time frame: Baseline to Week 12
description: Objective cough frequency measured by ambulatory cough monitoring device
measure: Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline
time frame: Baseline to Week 2
description: Objective cough frequency measured by ambulatory cough monitoring device
measure: Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline
time frame: Week 4
description: Objective cough frequency measured by ambulatory cough monitoring device
measure: Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline
time frame: Baseline to Week 2
description: The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 2 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline
time frame: Baseline to Week 4
description: The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 4 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline
time frame: Baseline to Week 8
description: The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 8 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline
time frame: Baseline to Week 12
description: The Leicester Cough Questionnaire (LCQ) is a 19 item questionnaire that assessed cough related quality of life. It has three domains (physical, psychological and social) and subjects were asked to complete it based on their experience in a recall period of 12 weeks. The total score range is 3 to 21 and domain scores each range from 1 to 7; a higher score indicated a better quality of life. Subjects completed the LCQ whilst in the clinic at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time
time frame: Baseline to Week 2
description: The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time
time frame: Baseline to Week 4
description: The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time
time frame: Baseline to Week 8
description: The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time
time frame: Baseline to Week 12
description: The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time
time frame: Baseline to Week 2
description: The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time
time frame: Baseline to Week 4
description: The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time
time frame: Baseline to Week 8
description: The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time
time frame: Baseline to Week 12
description: The cough VAS is a 100 mm scale on which subjects indicated their severity of cough over the previous 24 hours, both during the day-time and during night time separately. The VAS ranged from "no cough" (0 mm) on the left to "worst cough" (100 mm) on the right. Subjects completed the cough severity VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline
time frame: Baseline to Week 2
description: The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline
time frame: Baseline to Week 4
description: The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline
time frame: Baseline to Week 8
description: The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline
time frame: Baseline to Week 12
description: The urge-to-cough VAS was a 100 mm scale on which subjects indicated their urge to cough over the previous 24 hours (day/awake time and night time combined). The VAS ranged from "no urge to cough" (0 mm) on the left to "severe urge to cough" (100 mm) on the right. Subjects completed the urge to cough VAS at baseline/Day 1 (pre dose) and at Weeks 2, 4, 8, and 12.
measure: Global Rating of Change in Cough Frequency at Week 2
time frame: Baseline to Week 2
description: In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
measure: Global Rating of Change in Cough Frequency at Week 4
time frame: Baseline to Week 4
description: In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
measure: Global Rating of Change in Cough Frequency at Week 8
time frame: Baseline to Week 8
description: In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
measure: Global Rating of Change in Cough Frequency at Week 12
time frame: Baseline to Week 12
description: In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
measure: Global Rating of Change in Cough Severity at Week 2
time frame: Baseline to Week 2
description: In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
measure: Global Rating of Change in Cough Severity at Week 4
time frame: Baseline to Week 4
description: In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
measure: Global Rating of Change in Cough Severity at Week 8
time frame: Baseline to Week 8
description: In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
measure: Global Rating of Change in Cough Severity at Week 12
time frame: Baseline to Week 12
description: In the Global Rating of Change scale, subjects indicated if there had been a change in their symptoms (cough frequency and, separately, cough severity) since starting the IMP. Subjects responded with "worse", "about the same" or "better". If subjects indicated a change (either "worse" or "better") they then indicated on a 7 point scale the degree of change ranging from 1 (almost the same, hardly any change) to 7 (a very great deal changed). Subjects documented their Global Rating of Change in cough frequency and cough severity at Weeks 2, 4, 8, and 12.
arm group label: Orvepitant 10mg
arm group type: Experimental
description: Orvepitant 10mg tablet, once daily for 12 weeks
arm group label: Orvepitant 20mg
arm group type: Experimental
description: Orvepitant 20mg tablet, once daily for 12 weeks
arm group label: Orvepitant 30mg
arm group type: Experimental
description: Orvepitant 30mg tablet, once daily for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo to match tablet, once daily for 12 weeks
intervention type: Drug
intervention name: Orvepitant Maleate
description: Tablet, once daily, oral
arm group label: Orvepitant 10mg
arm group label: Orvepitant 20mg
arm group label: Orvepitant 30mg
intervention type: Drug
intervention name: Placebo
description: Tablet, once daily, oral
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Canada
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Cough
mesh term: Maleic acid
sharing ipd: No
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