<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/NCT03000348</url>
  </required_header>
  <id_info>
    <org_study_id>NBTCS02</org_study_id>
    <nct_id>NCT03000348</nct_id>
  </id_info>
  <brief_title>A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations</brief_title>
  <acronym>CARE-CF1</acronym>
  <official_title>A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients Being Treated for an Exacerbation of CF-associated Lung Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NovaBiotics Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agility Clinical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>PSR Group B.V.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NovaBiotics Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis&#xD;
      who are experiencing an exacerbation of CF-associated lung disease. There are six different&#xD;
      potential dosing regimens, including one that is placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, double-blind, randomized, placebo-controlled, 6-arm study to&#xD;
      investigate the optimal dose regimen, efficacy, and safety of cysteamine in the treatment of&#xD;
      adult patients with CF who are experiencing an exacerbation of CF-associated lung disease.&#xD;
      Patients will be screened for the study and eligible patients will be randomized to receive&#xD;
      either cysteamine or placebo as add-on therapy to their standard of care treatment for&#xD;
      CF-associated lung disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Sputum Bacterial Load</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>Change from baseline through to Day 21 in log10 cfu/ml transformed total gram negative sputum bacterial load</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and Tolerability Assessed by the Number of Subjects With Adverse Events</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>Assessed by variables such as adverse events (AEs), laboratory assessments, physical examinations, and vital signs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Neutrophil Elastase Levels</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>Actual values and change from baseline in neutrophil elastase levels were summarized using descriptive statistics by visit for each treatment group and each TDD group for the ITT Population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Sputum IL8</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>Sputum IL-8 Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in FEV1</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in BMI</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>BMI (kg/m^2) by Visit - ANCOVA with Observed Data ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in C-Reactive Protein</measure>
    <time_frame>Baseline through Day 21</time_frame>
    <description>Change from baseline in C-Reactive Protein at visits 7, 14 and 21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Blood Leukocyte Count</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>Blood Leukocyte Count (10^9 leucocytes/L) by Visit - ANCOVA with Observed Data ITT Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Blood Cysteamine Levels</measure>
    <time_frame>Day 14</time_frame>
    <description>Study Drug Plasma at Day 14 Safety Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Sputum Cysteamine Levels</measure>
    <time_frame>Day 14</time_frame>
    <description>Study Drug Sputum Concentrations at Day 14 Safety Population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CFRSD-CRISS</measure>
    <time_frame>Baseline through to Day 21</time_frame>
    <description>Mean Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD)-Chronic Respiratory Infection Symptom Scale (CRISS) CRFSD-CRISS:The CFRSD is a 16-item PROM to evaluate the effect of treatment on the severity of symptoms of acute respiratory infections associated with CF (i.e., CFRSD-CRISS) and to assess the emotional and activity impacts of these symptoms. The overall CRISS score range is 0-100 with 100 being the most severe symptoms.The CFRSD-CRISS is a validated unidimensional scale based on a subset of 8 items from the CFRSD questionnaire that quantifies symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recover from an exacerbation. The 8 items on the CFRSD-CRISS were scored using a 5-point Likert scale ranging from 0 (no symptom) to 4 (the highest magnitude of severity). So score range of 0-32.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CFQ-R</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>The CFQ-R is a disease-specific HRQOL (Health related quality of life) measure containing both generic and CF-specific scales and measures functioning during the previous 2 weeks. Each CFQ-R scale yielded standardized scores ranging from 0 to 100; higher scores indicated better HRQOL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Jarad and Sequeiros Symptom Score Questionnaire</measure>
    <time_frame>changes from baseline at day 7 and day 14</time_frame>
    <description>The Jarad and Sequeiros Symptom Questionnaire (Jarad, 2012) is a simple participant-completed questionnaire that assesses and evaluates change in participant symptoms related to different aspects of respiratory function during a CF exacerbation. The questionnaire consists of 4 questions, each answered on a 4-point scale ranging from 1 (best) to 4 (worst). A range of minimum 4 to maximum16.Jarad and Sequeiros Questionnaire Score - changes from baseline at day 7 and day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Weight</measure>
    <time_frame>Baseline through Day 21/End of Study</time_frame>
    <description>Weight (kg) by visit - ANCOVA with observed data</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>High Dose, Once per day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient takes one oral dose of Cysteamine (high dose) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose, Twice per day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient takes two oral doses of Cysteamine (high dose) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High Dose, Three times per day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Dose, Three times per day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient takes three oral doses of Cysteamine (low dose) per day, one in the morning, one at mid-day and one in the evening.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mid-Range Dose, Three times per day</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient takes three oral doses of Cysteamine (mid-range dose) per day, one in the morning, one at mid-day and one in the evening.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cysteamine</intervention_name>
    <description>Oral Cysteamine Capsule</description>
    <arm_group_label>High Dose, Once per day</arm_group_label>
    <arm_group_label>High Dose, Three times per day</arm_group_label>
    <arm_group_label>High Dose, Twice per day</arm_group_label>
    <arm_group_label>Low Dose, Three times per day</arm_group_label>
    <arm_group_label>Mid-Range Dose, Three times per day</arm_group_label>
    <other_name>Lynovex</other_name>
    <other_name>NM001</other_name>
    <other_name>Lynovex Oral</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>Placebo Oral Capsule</description>
    <arm_group_label>High Dose, Once per day</arm_group_label>
    <arm_group_label>High Dose, Twice per day</arm_group_label>
    <arm_group_label>Low Dose, Three times per day</arm_group_label>
    <arm_group_label>Mid-Range Dose, Three times per day</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. CF-associated lung disease with documented history of chronic infection with&#xD;
             Gram-negative organism(s)&#xD;
&#xD;
          2. Established patient of the Principal Investigator's CF Multi Disciplinary Team (MDT)&#xD;
&#xD;
          3. Age ≥18 years&#xD;
&#xD;
          4. Weight &gt;40 kg&#xD;
&#xD;
          5. FEV1 &gt;30% of predicted within the 6 months prior to study exacerbation&#xD;
&#xD;
          6. At the baseline visit: experiencing a new exacerbation of CF-associated lung disease&#xD;
             (based on Investigator assessment of ≥4 symptoms present on the Fuchs' criteria)&#xD;
             requiring treatment that includes an aminoglycoside antibiotic&#xD;
&#xD;
          7. Females of childbearing potential will be included if they are either sexually&#xD;
             inactive (sexually abstinent for 14 days prior to the first study drug dose continuing&#xD;
             through 28 days after the last study drug dose, or using one of the following highly&#xD;
             effective contraceptive (i.e. results in &lt;1% failure rate when used consistently and&#xD;
             correctly) methods in this trial:&#xD;
&#xD;
               1. intrauterine device (IUD);&#xD;
&#xD;
               2. surgical sterilization of the partner (vasectomy for 6 months minimum);&#xD;
&#xD;
               3. combined (estrogen or progestogen containing) hormonal contraception associated&#xD;
                  with the inhibition of ovulation (either oral, intravaginal, or transdermal);&#xD;
&#xD;
               4. progestogen only hormonal contraception associated with the inhibition of&#xD;
                  ovulation (either oral, injectable, or implantable);&#xD;
&#xD;
               5. intrauterine hormone releasing system (IUS);&#xD;
&#xD;
               6. bilateral tubal occlusion.&#xD;
&#xD;
          8. Females of childbearing potential agree to remain sexually inactive or to keep the&#xD;
             same birth control method for at least 28 days following the last dose.&#xD;
&#xD;
          9. A female of non-childbearing potential must have undergone one of the following&#xD;
             sterilization procedures at least 6 months prior to the first study drug dose:&#xD;
&#xD;
               1. hysteroscopic sterilization;&#xD;
&#xD;
               2. bilateral tubal ligation or bilateral salpingectomy;&#xD;
&#xD;
               3. hysterectomy;&#xD;
&#xD;
               4. bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 1 year&#xD;
                  prior to the first study drug dose and follicle stimulating hormone (FSH) serum&#xD;
                  levels consistent with postmenopausal status.&#xD;
&#xD;
         10. A non-vasectomized male subject agrees to use a condom with spermicide or abstain from&#xD;
             sexual intercourse during the study until 90 days beyond the last dose of study&#xD;
             medication and the female partner agrees to comply with inclusion 7 or 9. For a&#xD;
             vasectomized male who has had his vasectomy 6 months or more prior to study start, it&#xD;
             is required that they use a condom during sexual intercourse. A male who has been&#xD;
             vasectomized less than 6 months prior to study start must follow the same restrictions&#xD;
             as a non-vasectomized male.&#xD;
&#xD;
         11. If male, agrees not to donate sperm from the first study drug dose until 90 days after&#xD;
             dosing.&#xD;
&#xD;
         12. Willing and able to comply with all protocol requirements and procedures, including&#xD;
             induction of sputum, if necessary&#xD;
&#xD;
         13. Willing and able to provide signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitive to cysteamine or to any of the excipients&#xD;
&#xD;
          2. Hypersensitive to penicillamine&#xD;
&#xD;
          3. Transplant recipient&#xD;
&#xD;
          4. Participation in any other interventional clinical research study (participation in&#xD;
             observational studies is not exclusionary) within 30 days of Baseline (Day 0), and any&#xD;
             planned participation in an interventional clinical research study for the duration of&#xD;
             this study&#xD;
&#xD;
          5. If female, pregnancy, planned pregnancy, or breast-feeding&#xD;
&#xD;
          6. Any other significant disease/disorder which, in the Investigator's opinion, either&#xD;
             puts the patient at risk due to study participation, or may influence the results of&#xD;
             the study or the patient's ability to participate in the study&#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>Banner University of Arizona Medical Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Francisco Critical Care Medical Group California Pacific Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Florida Pulmonary</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical College</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical College of Wisconsin/Froedtert Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Padiatrico Bambino Gesu Centro Fibrosi Cistica</name>
      <address>
        <city>Roma</city>
        <zip>00165</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Integrato di Verona Borgo Trento Centro Fibrosi Cistica</name>
      <address>
        <city>Verona</city>
        <zip>37126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aberdeen Royal Infirmary</name>
      <address>
        <city>Aberdeen</city>
        <state>Scotland</state>
        <zip>AB25 2ZN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ninewells Hospital Scottish Adult Cystic Fibrosis Service</name>
      <address>
        <city>Dundee</city>
        <zip>DD1 9SY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital Edinburgh, CF Adults / CF Unit</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 3HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS GGC</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raigmore Hospital</name>
      <address>
        <city>Inverness</city>
        <zip>IV2 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. James University Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Infirmary Adult CF Centre</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.novabiotics.co.uk/</url>
    <description>NovaBiotics Website</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <results_first_submitted>February 10, 2021</results_first_submitted>
  <results_first_submitted_qc>April 13, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 14, 2021</results_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exacerbation</keyword>
  <keyword>CF</keyword>
  <keyword>Lung disease</keyword>
  <keyword>Lung infection</keyword>
  <keyword>Gram negative</keyword>
  <keyword>Bacterial Infection</keyword>
  <keyword>pneumonia</keyword>
  <keyword>bronchitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysteamine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03000348/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>91 adult CF patients experiencing a pulmonary exacerbation were enrolled across 15 US and EU centres. 89 patients were randomised and 78 completed the 14 day treatment period of the study. First Patient first visit was 12 Jan 2017 and Last Patient last visit was 11 April 2018.</recruitment_details>
      <pre_assignment_details>Of the 91 patients enrolled 89 patients met the inclusion criteria and 2 were not eligible:&#xD;
1 patient had &lt;4 Fuchs criteria (not considered to be exacerbating)&#xD;
1 patient had reproductive issues</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="P2">
          <title>450mg, Once Per Day</title>
          <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="P3">
          <title>150mg, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="P4">
          <title>450mg, Twice Per Day</title>
          <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="P5">
          <title>300mg, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="P6">
          <title>450mg, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="16"/>
                <participants group_id="P6" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Day 14 Treatment Period</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="13"/>
                <participants group_id="P6" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="12"/>
                <participants group_id="P5" count="11"/>
                <participants group_id="P6" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to expectorate sputum</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 group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No gram negative</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Patient had no transport</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Dosing</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="B2">
          <title>450mg, Once Per Day</title>
          <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="B3">
          <title>150mg, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="B4">
          <title>450mg, Twice Per Day</title>
          <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="B5">
          <title>300mg, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="B6">
          <title>450mg, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="17"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="15"/>
            <count group_id="B5" value="16"/>
            <count group_id="B6" value="15"/>
            <count group_id="B7" value="89"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.2" spread="5.64"/>
                    <measurement group_id="B2" value="27.5" spread="6.77"/>
                    <measurement group_id="B3" value="32.5" spread="12.7"/>
                    <measurement group_id="B4" value="32.3" spread="9.78"/>
                    <measurement group_id="B5" value="31.4" spread="12.0"/>
                    <measurement group_id="B6" value="27.5" spread="7.89"/>
                    <measurement group_id="B7" value="29.8" spread="9.59"/>
                  </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="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="46"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="15"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="78"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.2" spread="2.23"/>
                    <measurement group_id="B2" value="20.3" spread="3.03"/>
                    <measurement group_id="B3" value="20.7" spread="2.41"/>
                    <measurement group_id="B4" value="21.5" spread="2.21"/>
                    <measurement group_id="B5" value="20.5" spread="3.03"/>
                    <measurement group_id="B6" value="21.7" spread="2.84"/>
                    <measurement group_id="B7" value="20.8" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age at CF Diagnosis</title>
          <description>Age at CF diagnosis was calculated as the date of CF diagnosis-date of birth</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.9" spread="2.41"/>
                    <measurement group_id="B2" value="3.9" spread="0.24"/>
                    <measurement group_id="B3" value="0.3" spread="0.49"/>
                    <measurement group_id="B4" value="1.6" spread="4.93"/>
                    <measurement group_id="B5" value="4.8" spread="11.45"/>
                    <measurement group_id="B6" value="1.8" spread="5.63"/>
                    <measurement group_id="B7" value="0.9" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of CF years</title>
          <description>Duration of CF was calculated as the informed consent date - the date of diagnosis/365.25</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.36" spread="5.69"/>
                    <measurement group_id="B2" value="23.7" spread="9.26"/>
                    <measurement group_id="B3" value="32.45" spread="12.44"/>
                    <measurement group_id="B4" value="31.11" spread="10.92"/>
                    <measurement group_id="B5" value="26.76" spread="11.69"/>
                    <measurement group_id="B6" value="25.88" spread="7.07"/>
                    <measurement group_id="B7" value="27.85" spread="9.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>FEV1 Percent predicted (%)</title>
          <units>litres per second</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.5" spread="15.31"/>
                    <measurement group_id="B2" value="39.4" spread="19.81"/>
                    <measurement group_id="B3" value="48.0" spread="18.26"/>
                    <measurement group_id="B4" value="46.1" spread="22.75"/>
                    <measurement group_id="B5" value="37.7" spread="13.44"/>
                    <measurement group_id="B6" value="46.9" spread="20.58"/>
                    <measurement group_id="B7" value="43.3" spread="18.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Sputum Bacterial Load</title>
        <description>Change from baseline through to Day 21 in log10 cfu/ml transformed total gram negative sputum bacterial load</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>Intention to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>High Dose, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sputum Bacterial Load</title>
          <description>Change from baseline through to Day 21 in log10 cfu/ml transformed total gram negative sputum bacterial load</description>
          <population>Intention to treat population</population>
          <units>log 10 cfu/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="2.887"/>
                    <measurement group_id="O2" value="-1.03" spread="3.124"/>
                    <measurement group_id="O3" value="-1.28" spread="1.978"/>
                    <measurement group_id="O4" value="-1.7" spread="2.439"/>
                    <measurement group_id="O5" value="-1.03" spread="1.997"/>
                    <measurement group_id="O6" value="-0.25" spread="2.228"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.38" spread="2.291"/>
                    <measurement group_id="O2" value="0.12" spread="2.045"/>
                    <measurement group_id="O3" value="-1.24" spread="2.686"/>
                    <measurement group_id="O4" value="-1.32" spread="2.298"/>
                    <measurement group_id="O5" value="-0.98" spread="1.894"/>
                    <measurement group_id="O6" value="0.33" spread="2.270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="1.238"/>
                    <measurement group_id="O2" value="-1.22" spread="2.760"/>
                    <measurement group_id="O3" value="-0.26" spread="1.639"/>
                    <measurement group_id="O4" value="-1.04" spread="2.891"/>
                    <measurement group_id="O5" value="-0.87" spread="1.677"/>
                    <measurement group_id="O6" value="0.93" spread="2.348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Safety and Tolerability Assessed by the Number of Subjects With Adverse Events</title>
        <description>Assessed by variables such as adverse events (AEs), laboratory assessments, physical examinations, and vital signs.</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>Summary of participant reported adverse events (AEs) by study group</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Safety and Tolerability Assessed by the Number of Subjects With Adverse Events</title>
          <description>Assessed by variables such as adverse events (AEs), laboratory assessments, physical examinations, and vital signs.</description>
          <population>Summary of participant reported adverse events (AEs) by study group</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="40"/>
                    <measurement group_id="O4" value="33"/>
                    <measurement group_id="O5" value="45"/>
                    <measurement group_id="O6" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 or more AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="10"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity of AE mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity of AE moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severity of AE severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to drug discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decreased appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haemoptysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oropharyngeal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breath odour</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Neutrophil Elastase Levels</title>
        <description>Actual values and change from baseline in neutrophil elastase levels were summarized using descriptive statistics by visit for each treatment group and each TDD group for the ITT Population.</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>Neutrophil Elastase Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine 450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Neutrophil Elastase Levels</title>
          <description>Actual values and change from baseline in neutrophil elastase levels were summarized using descriptive statistics by visit for each treatment group and each TDD group for the ITT Population.</description>
          <population>Neutrophil Elastase Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4659" spread="38335"/>
                    <measurement group_id="O2" value="23431" spread="53111"/>
                    <measurement group_id="O3" value="704" spread="36395"/>
                    <measurement group_id="O4" value="-19623" spread="35548"/>
                    <measurement group_id="O5" value="-15769" spread="40899"/>
                    <measurement group_id="O6" value="5135" spread="27791"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3706" spread="42879"/>
                    <measurement group_id="O2" value="-380" spread="157122"/>
                    <measurement group_id="O3" value="-7208" spread="19210"/>
                    <measurement group_id="O4" value="-12014" spread="23269"/>
                    <measurement group_id="O5" value="-14083" spread="41215"/>
                    <measurement group_id="O6" value="14660" spread="35539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1000" spread="59856"/>
                    <measurement group_id="O2" value="4853" spread="18616"/>
                    <measurement group_id="O3" value="171" spread="19229"/>
                    <measurement group_id="O4" value="-21002" spread="2472"/>
                    <measurement group_id="O5" value="-14591" spread="39179"/>
                    <measurement group_id="O6" value="-2558" spread="20068"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Sputum IL8</title>
        <description>Sputum IL-8 Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Sputum IL8</title>
          <description>Sputum IL-8 Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population</description>
          <population>ITT Population</population>
          <units>pg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26088" spread="55506"/>
                    <measurement group_id="O2" value="-17864" spread="33785"/>
                    <measurement group_id="O3" value="-5511" spread="46204"/>
                    <measurement group_id="O4" value="111574" spread="70338"/>
                    <measurement group_id="O5" value="-2663" spread="41802"/>
                    <measurement group_id="O6" value="-25785" spread="53721"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28856" spread="39456"/>
                    <measurement group_id="O2" value="-26528" spread="46737"/>
                    <measurement group_id="O3" value="-33653" spread="55302"/>
                    <measurement group_id="O4" value="3167" spread="28204"/>
                    <measurement group_id="O5" value="-6136" spread="53611"/>
                    <measurement group_id="O6" value="221" spread="30639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9576" spread="66157"/>
                    <measurement group_id="O2" value="-16043" spread="34551"/>
                    <measurement group_id="O3" value="-19778" spread="49306"/>
                    <measurement group_id="O4" value="2831" spread="23050"/>
                    <measurement group_id="O5" value="631" spread="32350"/>
                    <measurement group_id="O6" value="-10671" spread="65656"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in FEV1</title>
        <description>Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in FEV1</title>
          <description>Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population</description>
          <population>Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population</population>
          <units>percentage of predicted</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="13.67"/>
                    <measurement group_id="O2" value="4.4" spread="5.52"/>
                    <measurement group_id="O3" value="6.9" spread="8.85"/>
                    <measurement group_id="O4" value="11.8" spread="9.96"/>
                    <measurement group_id="O5" value="4.9" spread="5.48"/>
                    <measurement group_id="O6" value="3.7" spread="8.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" spread="14.03"/>
                    <measurement group_id="O2" value="4.0" spread="5.14"/>
                    <measurement group_id="O3" value="8.9" spread="10.87"/>
                    <measurement group_id="O4" value="13.6" spread="10.83"/>
                    <measurement group_id="O5" value="5.3" spread="6.65"/>
                    <measurement group_id="O6" value="7.5" spread="7.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.5" spread="13.5"/>
                    <measurement group_id="O2" value="4.7" spread="5.03"/>
                    <measurement group_id="O3" value="6.5" spread="7.25"/>
                    <measurement group_id="O4" value="8.9" spread="10.66"/>
                    <measurement group_id="O5" value="6.4" spread="8.18"/>
                    <measurement group_id="O6" value="6.3" spread="11.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in BMI</title>
        <description>BMI (kg/m^2) by Visit - ANCOVA with Observed Data ITT Population</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in BMI</title>
          <description>BMI (kg/m^2) by Visit - ANCOVA with Observed Data ITT Population</description>
          <population>ITT</population>
          <units>kg/m^2 for BMI</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BMI Day 7 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="0.371"/>
                    <measurement group_id="O2" value="0.32" spread="0.498"/>
                    <measurement group_id="O3" value="0.28" spread="0.3"/>
                    <measurement group_id="O4" value="0.24" spread="0.428"/>
                    <measurement group_id="O5" value="0.15" spread="0.586"/>
                    <measurement group_id="O6" value="0.15" spread="0.589"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMI Day 14 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.452"/>
                    <measurement group_id="O2" value="0.64" spread="0.505"/>
                    <measurement group_id="O3" value="0.34" spread="0.477"/>
                    <measurement group_id="O4" value="0.37" spread="0.488"/>
                    <measurement group_id="O5" value="0.23" spread="0.705"/>
                    <measurement group_id="O6" value="0.32" spread="0.893"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BMI Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="11"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="0.537"/>
                    <measurement group_id="O2" value="0.55" spread="0.553"/>
                    <measurement group_id="O3" value="0.47" spread="0.564"/>
                    <measurement group_id="O4" value="0.18" spread="0.478"/>
                    <measurement group_id="O5" value="-0.02" spread="0.980"/>
                    <measurement group_id="O6" value="0.12" spread="0.828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in C-Reactive Protein</title>
        <description>Change from baseline in C-Reactive Protein at visits 7, 14 and 21</description>
        <time_frame>Baseline through Day 21</time_frame>
        <population>CRP by visit ANCOVA with observed data ITT population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in C-Reactive Protein</title>
          <description>Change from baseline in C-Reactive Protein at visits 7, 14 and 21</description>
          <population>CRP by visit ANCOVA with observed data ITT population</population>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-182.828" spread="188.1222"/>
                    <measurement group_id="O2" value="-285.006" spread="295.0114"/>
                    <measurement group_id="O3" value="-229.821" spread="590.1267"/>
                    <measurement group_id="O4" value="-318.933" spread="344.9138"/>
                    <measurement group_id="O5" value="-120.193" spread="200.2307"/>
                    <measurement group_id="O6" value="-281.752" spread="293.2595"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-75.671" spread="331.2220"/>
                    <measurement group_id="O2" value="-312.435" spread="323.8782"/>
                    <measurement group_id="O3" value="-216.105" spread="617.1174"/>
                    <measurement group_id="O4" value="-215.242" spread="225.7293"/>
                    <measurement group_id="O5" value="-111.272" spread="124.8394"/>
                    <measurement group_id="O6" value="-294.13" spread="509.9255"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.341" spread="296.4493"/>
                    <measurement group_id="O2" value="-237.062" spread="378.4493"/>
                    <measurement group_id="O3" value="-116.442" spread="730.9709"/>
                    <measurement group_id="O4" value="-198.759" spread="235.0256"/>
                    <measurement group_id="O5" value="-23.421" spread="157.4203"/>
                    <measurement group_id="O6" value="-225.787" spread="543.1070"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Blood Leukocyte Count</title>
        <description>Blood Leukocyte Count (10^9 leucocytes/L) by Visit - ANCOVA with Observed Data ITT Population</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Blood Leukocyte Count</title>
          <description>Blood Leukocyte Count (10^9 leucocytes/L) by Visit - ANCOVA with Observed Data ITT Population</description>
          <population>ITT</population>
          <units>10^9 leucocytes/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.553" spread="4.617"/>
                    <measurement group_id="O2" value="-1.836" spread="2.0566"/>
                    <measurement group_id="O3" value="-2.808" spread="3.595"/>
                    <measurement group_id="O4" value="-2.482" spread="3.4502"/>
                    <measurement group_id="O5" value="-2.575" spread="3.1189"/>
                    <measurement group_id="O6" value="-2.863" spread="2.9932"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.568" spread="4.7176"/>
                    <measurement group_id="O2" value="-2.220" spread="2.3451"/>
                    <measurement group_id="O3" value="-2.648" spread="3.9122"/>
                    <measurement group_id="O4" value="-3.419" spread="3.5734"/>
                    <measurement group_id="O5" value="-0.193" spread="3.8376"/>
                    <measurement group_id="O6" value="-4.066" spread="2.4102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.870" spread="4.6187"/>
                    <measurement group_id="O2" value="-1.757" spread="2.6670"/>
                    <measurement group_id="O3" value="-1.880" spread="3.0935"/>
                    <measurement group_id="O4" value="-1.763" spread="3.3193"/>
                    <measurement group_id="O5" value="-0.127" spread="2.5869"/>
                    <measurement group_id="O6" value="-3.316" spread="3.6322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Blood Cysteamine Levels</title>
        <description>Study Drug Plasma at Day 14 Safety Population</description>
        <time_frame>Day 14</time_frame>
        <population>Safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Blood Cysteamine Levels</title>
          <description>Study Drug Plasma at Day 14 Safety Population</description>
          <population>Safety population</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="0.00"/>
                    <measurement group_id="O2" value="515.11" spread="683.956"/>
                    <measurement group_id="O3" value="102.45" spread="144.863"/>
                    <measurement group_id="O4" value="347.76" spread="507.747"/>
                    <measurement group_id="O5" value="256.85" spread="377.262"/>
                    <measurement group_id="O6" value="256.84" spread="251.593"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Sputum Cysteamine Levels</title>
        <description>Study Drug Sputum Concentrations at Day 14 Safety Population</description>
        <time_frame>Day 14</time_frame>
        <population>Safety Population - there are fewer numbers of patients due to the inability of some patients to provide sputum samples</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Sputum Cysteamine Levels</title>
          <description>Study Drug Sputum Concentrations at Day 14 Safety Population</description>
          <population>Safety Population - there are fewer numbers of patients due to the inability of some patients to provide sputum samples</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="12"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.0" spread="0.00"/>
                    <measurement group_id="O2" value="682.8" spread="1009.8"/>
                    <measurement group_id="O3" value="150.0" spread="0.0"/>
                    <measurement group_id="O4" value="316.4" spread="1423.6"/>
                    <measurement group_id="O5" value="739.7" spread="1423.6"/>
                    <measurement group_id="O6" value="811.1" spread="917.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CFRSD-CRISS</title>
        <description>Mean Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD)-Chronic Respiratory Infection Symptom Scale (CRISS) CRFSD-CRISS:The CFRSD is a 16-item PROM to evaluate the effect of treatment on the severity of symptoms of acute respiratory infections associated with CF (i.e., CFRSD-CRISS) and to assess the emotional and activity impacts of these symptoms. The overall CRISS score range is 0-100 with 100 being the most severe symptoms.The CFRSD-CRISS is a validated unidimensional scale based on a subset of 8 items from the CFRSD questionnaire that quantifies symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recover from an exacerbation. The 8 items on the CFRSD-CRISS were scored using a 5-point Likert scale ranging from 0 (no symptom) to 4 (the highest magnitude of severity). So score range of 0-32.</description>
        <time_frame>Baseline through to Day 21</time_frame>
        <population>Mean Change from Baseline in CRFSD-CRISS - Linear MMRM Model with Observed Data (ITT Population)</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CFRSD-CRISS</title>
          <description>Mean Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD)-Chronic Respiratory Infection Symptom Scale (CRISS) CRFSD-CRISS:The CFRSD is a 16-item PROM to evaluate the effect of treatment on the severity of symptoms of acute respiratory infections associated with CF (i.e., CFRSD-CRISS) and to assess the emotional and activity impacts of these symptoms. The overall CRISS score range is 0-100 with 100 being the most severe symptoms.The CFRSD-CRISS is a validated unidimensional scale based on a subset of 8 items from the CFRSD questionnaire that quantifies symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recover from an exacerbation. The 8 items on the CFRSD-CRISS were scored using a 5-point Likert scale ranging from 0 (no symptom) to 4 (the highest magnitude of severity). So score range of 0-32.</description>
          <population>Mean Change from Baseline in CRFSD-CRISS - Linear MMRM Model with Observed Data (ITT Population)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.4" spread="8.31"/>
                    <measurement group_id="O2" value="-18.1" spread="10.19"/>
                    <measurement group_id="O3" value="-11.9" spread="7.98"/>
                    <measurement group_id="O4" value="-19.1" spread="10.65"/>
                    <measurement group_id="O5" value="-10.5" spread="5.91"/>
                    <measurement group_id="O6" value="-17.8" spread="12.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.3" spread="15.0"/>
                    <measurement group_id="O2" value="-24.3" spread="16.35"/>
                    <measurement group_id="O3" value="-15.5" spread="12.48"/>
                    <measurement group_id="O4" value="-28.1" spread="16.88"/>
                    <measurement group_id="O5" value="-14.8" spread="8.53"/>
                    <measurement group_id="O6" value="-23.9" spread="16.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.3" spread="11.7"/>
                    <measurement group_id="O2" value="-23.2" spread="13.36"/>
                    <measurement group_id="O3" value="-15.8" spread="11.68"/>
                    <measurement group_id="O4" value="-19.9" spread="19.23"/>
                    <measurement group_id="O5" value="-12.9" spread="6.37"/>
                    <measurement group_id="O6" value="22.0" spread="17.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CFQ-R</title>
        <description>The CFQ-R is a disease-specific HRQOL (Health related quality of life) measure containing both generic and CF-specific scales and measures functioning during the previous 2 weeks. Each CFQ-R scale yielded standardized scores ranging from 0 to 100; higher scores indicated better HRQOL</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>Change from Baseline to Day 14 in CFQ-R Respiratory Score: ANCOVA with Observed Data ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CFQ-R</title>
          <description>The CFQ-R is a disease-specific HRQOL (Health related quality of life) measure containing both generic and CF-specific scales and measures functioning during the previous 2 weeks. Each CFQ-R scale yielded standardized scores ranging from 0 to 100; higher scores indicated better HRQOL</description>
          <population>Change from Baseline to Day 14 in CFQ-R Respiratory Score: ANCOVA with Observed Data ITT Population</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7 Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7" spread="18.21"/>
                    <measurement group_id="O2" value="12.2" spread="13.81"/>
                    <measurement group_id="O3" value="12.0" spread="16.32"/>
                    <measurement group_id="O4" value="12.1" spread="14.95"/>
                    <measurement group_id="O5" value="15.9" spread="14.1"/>
                    <measurement group_id="O6" value="19.6" spread="16.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="21.51"/>
                    <measurement group_id="O2" value="24.4" spread="14.15"/>
                    <measurement group_id="O3" value="19.7" spread="16.76"/>
                    <measurement group_id="O4" value="31.3" spread="17.38"/>
                    <measurement group_id="O5" value="21.8" spread="14.07"/>
                    <measurement group_id="O6" value="28.6" spread="15.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3" spread="19.34"/>
                    <measurement group_id="O2" value="30.6" spread="17.62"/>
                    <measurement group_id="O3" value="25.2" spread="19.19"/>
                    <measurement group_id="O4" value="31.3" spread="30.08"/>
                    <measurement group_id="O5" value="24.8" spread="14.85"/>
                    <measurement group_id="O6" value="37.3" spread="23.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Jarad and Sequeiros Symptom Score Questionnaire</title>
        <description>The Jarad and Sequeiros Symptom Questionnaire (Jarad, 2012) is a simple participant-completed questionnaire that assesses and evaluates change in participant symptoms related to different aspects of respiratory function during a CF exacerbation. The questionnaire consists of 4 questions, each answered on a 4-point scale ranging from 1 (best) to 4 (worst). A range of minimum 4 to maximum16.Jarad and Sequeiros Questionnaire Score - changes from baseline at day 7 and day 14</description>
        <time_frame>changes from baseline at day 7 and day 14</time_frame>
        <population>ITT Linear MMRM Model with Observed Data</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Jarad and Sequeiros Symptom Score Questionnaire</title>
          <description>The Jarad and Sequeiros Symptom Questionnaire (Jarad, 2012) is a simple participant-completed questionnaire that assesses and evaluates change in participant symptoms related to different aspects of respiratory function during a CF exacerbation. The questionnaire consists of 4 questions, each answered on a 4-point scale ranging from 1 (best) to 4 (worst). A range of minimum 4 to maximum16.Jarad and Sequeiros Questionnaire Score - changes from baseline at day 7 and day 14</description>
          <population>ITT Linear MMRM Model with Observed Data</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>change from baseline to day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.6" spread="1.97"/>
                    <measurement group_id="O2" value="-1.9" spread="2.38"/>
                    <measurement group_id="O3" value="-1.4" spread="1.85"/>
                    <measurement group_id="O4" value="-3.3" spread="2.35"/>
                    <measurement group_id="O5" value="-2.4" spread="2.21"/>
                    <measurement group_id="O6" value="-3.1" spread="3.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change from baseline to day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.2" spread="2.9"/>
                    <measurement group_id="O2" value="-2.9" spread="2.6"/>
                    <measurement group_id="O3" value="-2.0" spread="2.48"/>
                    <measurement group_id="O4" value="-4.3" spread="2.16"/>
                    <measurement group_id="O5" value="-3.1" spread="2.63"/>
                    <measurement group_id="O6" value="-4.2" spread="3.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Weight</title>
        <description>Weight (kg) by visit - ANCOVA with observed data</description>
        <time_frame>Baseline through Day 21/End of Study</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O2">
            <title>450mg, Once Per Day</title>
            <description>Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O3">
            <title>150mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O4">
            <title>450mg, Twice Per Day</title>
            <description>Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O5">
            <title>300mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
          </group>
          <group group_id="O6">
            <title>450mg, Three Times Per Day</title>
            <description>Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Weight</title>
          <description>Weight (kg) by visit - ANCOVA with observed data</description>
          <population>ITT</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" spread="1.084"/>
                    <measurement group_id="O2" value="0.83" spread="1.241"/>
                    <measurement group_id="O3" value="0.79" spread="1.145"/>
                    <measurement group_id="O4" value="0.67" spread="1.182"/>
                    <measurement group_id="O5" value="0.25" spread="1.547"/>
                    <measurement group_id="O6" value="0.36" spread="1.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.85" spread="1.355"/>
                    <measurement group_id="O2" value="1.71" spread="1.270"/>
                    <measurement group_id="O3" value="0.96" spread="1.368"/>
                    <measurement group_id="O4" value="1.04" spread="1.445"/>
                    <measurement group_id="O5" value="0.55" spread="1.872"/>
                    <measurement group_id="O6" value="0.89" spread="2.621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="1.486"/>
                    <measurement group_id="O2" value="1.50" spread="1.639"/>
                    <measurement group_id="O3" value="1.30" spread="1.503"/>
                    <measurement group_id="O4" value="0.52" spread="1.295"/>
                    <measurement group_id="O5" value="-0.28" spread="2.728"/>
                    <measurement group_id="O6" value="0.34" spread="2.477"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up)</time_frame>
      <desc>An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="E2">
          <title>High Dose, Once Per Day</title>
          <description>Patient takes one oral dose of Cysteamine (high dose) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="E3">
          <title>Low Dose, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (low dose) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="E4">
          <title>High Dose, Twice Per Day</title>
          <description>Patient takes two oral doses of Cysteamine (high dose) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="E5">
          <title>Mid-Range Dose, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (mid-range dose) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule&#xD;
Placebo Oral Capsule: Placebo Oral Capsule</description>
        </group>
        <group group_id="E6">
          <title>High Dose, Three Times Per Day</title>
          <description>Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening.&#xD;
Cysteamine: Oral Cysteamine Capsule</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infective pulmonary exacerbation of CF</sub_title>
                <description>Pulmonary exacerbation hospitalisation prolongation of hospitalisation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Campylobacter sepsis</sub_title>
                <description>Campylobacter septicaemia hospitalisation prolongation of hospitalisation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <description>Depression exacerbation manifesting in suicidal and homicdal ideation</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <description>Kidney Stone</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <description>Prolongation of hospitalisation</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Axillary vein thrombosis</sub_title>
                <description>Right axillary deep vein thrombosis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="17"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="11"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="16"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="MedDRA (Unspecified)">Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Breath odour</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Gingival recession</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Post-tussive vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Administration site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Adminstration site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Crepitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sensation of foreign body</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infective pulmonary exacerbation of cystic fibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Urinary tract infection (bacterial)</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Campylobacter sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Clostridium difficle colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Clostridium difficle infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Tooth abcess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Infusion site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Stoma site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Pulmonary function test decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Carbon dioxide</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Colonoscopy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Mycobacterium tuberculosis complex test positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dysguesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Intention tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Oligomenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sinus Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Increased viscosity of bronchial secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Sputum retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pruritus allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Skin odour abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Sinus operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Axillary vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="15"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Deborah O'Neil, CEO</name_or_title>
      <organization>NovaBiotics Ltd</organization>
      <phone>01224 711 377</phone>
      <email>deborah@novabiotics.co.uk</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/NCT03000348
org study id: NBTCS02
nct id: NCT03000348
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis
      who are experiencing an exacerbation of CF-associated lung disease. There are six different
      potential dosing regimens, including one that is placebo.
This is a multicenter, double-blind, randomized, placebo-controlled, 6-arm study to
      investigate the optimal dose regimen, efficacy, and safety of cysteamine in the treatment of
      adult patients with CF who are experiencing an exacerbation of CF-associated lung disease.
      Patients will be screened for the study and eligible patients will be randomized to receive
      either cysteamine or placebo as add-on therapy to their standard of care treatment for
      CF-associated lung disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Sputum Bacterial Load
time frame: Baseline through Day 21/End of Study
description: Change from baseline through to Day 21 in log10 cfu/ml transformed total gram negative sputum bacterial load
measure: Safety and Tolerability Assessed by the Number of Subjects With Adverse Events
time frame: Baseline through Day 21/End of Study
description: Assessed by variables such as adverse events (AEs), laboratory assessments, physical examinations, and vital signs.
measure: Change From Baseline in Neutrophil Elastase Levels
time frame: Baseline through Day 21/End of Study
description: Actual values and change from baseline in neutrophil elastase levels were summarized using descriptive statistics by visit for each treatment group and each TDD group for the ITT Population.
measure: Change From Baseline in Sputum IL8
time frame: Baseline through Day 21/End of Study
description: Sputum IL-8 Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population
measure: Change From Baseline in FEV1
time frame: Baseline through Day 21/End of Study
description: Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population
measure: Change From Baseline in BMI
time frame: Baseline through Day 21/End of Study
description: BMI (kg/m^2) by Visit - ANCOVA with Observed Data ITT Population
measure: Change From Baseline in C-Reactive Protein
time frame: Baseline through Day 21
description: Change from baseline in C-Reactive Protein at visits 7, 14 and 21
measure: Change From Baseline in Blood Leukocyte Count
time frame: Baseline through Day 21/End of Study
description: Blood Leukocyte Count (10^9 leucocytes/L) by Visit - ANCOVA with Observed Data ITT Population
measure: Assessment of Blood Cysteamine Levels
time frame: Day 14
description: Study Drug Plasma at Day 14 Safety Population
measure: Assessment of Sputum Cysteamine Levels
time frame: Day 14
description: Study Drug Sputum Concentrations at Day 14 Safety Population
measure: Change From Baseline in CFRSD-CRISS
time frame: Baseline through to Day 21
description: Mean Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD)-Chronic Respiratory Infection Symptom Scale (CRISS) CRFSD-CRISS:The CFRSD is a 16-item PROM to evaluate the effect of treatment on the severity of symptoms of acute respiratory infections associated with CF (i.e., CFRSD-CRISS) and to assess the emotional and activity impacts of these symptoms. The overall CRISS score range is 0-100 with 100 being the most severe symptoms.The CFRSD-CRISS is a validated unidimensional scale based on a subset of 8 items from the CFRSD questionnaire that quantifies symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recover from an exacerbation. The 8 items on the CFRSD-CRISS were scored using a 5-point Likert scale ranging from 0 (no symptom) to 4 (the highest magnitude of severity). So score range of 0-32.
measure: Change From Baseline in CFQ-R
time frame: Baseline through Day 21/End of Study
description: The CFQ-R is a disease-specific HRQOL (Health related quality of life) measure containing both generic and CF-specific scales and measures functioning during the previous 2 weeks. Each CFQ-R scale yielded standardized scores ranging from 0 to 100; higher scores indicated better HRQOL
measure: Change From Baseline in Jarad and Sequeiros Symptom Score Questionnaire
time frame: changes from baseline at day 7 and day 14
description: The Jarad and Sequeiros Symptom Questionnaire (Jarad, 2012) is a simple participant-completed questionnaire that assesses and evaluates change in participant symptoms related to different aspects of respiratory function during a CF exacerbation. The questionnaire consists of 4 questions, each answered on a 4-point scale ranging from 1 (best) to 4 (worst). A range of minimum 4 to maximum16.Jarad and Sequeiros Questionnaire Score - changes from baseline at day 7 and day 14
measure: Change From Baseline in Weight
time frame: Baseline through Day 21/End of Study
description: Weight (kg) by visit - ANCOVA with observed data
arm group label: High Dose, Once per day
arm group type: Active Comparator
description: Patient takes one oral dose of Cysteamine (high dose) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening.
arm group label: High Dose, Twice per day
arm group type: Active Comparator
description: Patient takes two oral doses of Cysteamine (high dose) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day.
arm group label: High Dose, Three times per day
arm group type: Active Comparator
description: Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening.
arm group label: Low Dose, Three times per day
arm group type: Active Comparator
description: Patient takes three oral doses of Cysteamine (low dose) per day, one in the morning, one at mid-day and one in the evening.
arm group label: Mid-Range Dose, Three times per day
arm group type: Active Comparator
description: Patient takes three oral doses of Cysteamine (mid-range dose) per day, one in the morning, one at mid-day and one in the evening.
intervention type: Drug
intervention name: Cysteamine
description: Oral Cysteamine Capsule
arm group label: High Dose, Once per day
arm group label: High Dose, Three times per day
arm group label: High Dose, Twice per day
arm group label: Low Dose, Three times per day
arm group label: Mid-Range Dose, Three times per day
other name: Lynovex
other name: NM001
other name: Lynovex Oral
intervention type: Drug
intervention name: Placebo Oral Capsule
description: Placebo Oral Capsule
arm group label: High Dose, Once per day
arm group label: High Dose, Twice per day
arm group label: Low Dose, Three times per day
arm group label: Mid-Range Dose, Three times per day
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
country: United Kingdom
country: United States
url: http://www.novabiotics.co.uk/
description: NovaBiotics Website
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
mesh term: Cysteamine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 