<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/NCT03303911</url>
  </required_header>
  <id_info>
    <org_study_id>ACH-CYT-02</org_study_id>
    <nct_id>NCT03303911</nct_id>
  </id_info>
  <brief_title>A Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers</brief_title>
  <official_title>Repeat-Dose Pharmacokinetic and Pharmacodynamic Evaluation of Cytisine in Healthy Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Achieve Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Achieve Life Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of this study are:&#xD;
&#xD;
        -  To evaluate the pharmacokinetic (PK) parameters during repeat dosing of 1.5 mg or 3.0 mg&#xD;
           cytisine when administered as the commercial 25-day schedule.&#xD;
&#xD;
        -  To evaluate the pharmacodynamic (PD) effects (e.g., reduction in smoking) with repeat&#xD;
           dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    It has been difficult to recruit participants meeting study entry criteria that are &gt;65 years&#xD;
    of age and not for any safety reasons.&#xD;
  </why_stopped>
  <start_date type="Actual">October 6, 2017</start_date>
  <completion_date type="Actual">October 5, 2018</completion_date>
  <primary_completion_date type="Actual">October 5, 2018</primary_completion_date>
  <phase>Phase 1/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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Occurrence of Cmax (Tmax)</measure>
    <time_frame>after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Minimum Observed Plasma Concentration (Cmin)</measure>
    <time_frame>after the first dose on Days 4, 13, 17, 21 and 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time (AUC0-t)</measure>
    <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total AUC From Time Zero to Infinity (AUC0-∞)</measure>
    <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Residual Area or Percentage of Extrapolated Part for the Calculation of AUC0-∞ (%AUC)</measure>
    <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Rate Constant (λz)</measure>
    <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent Terminal Elimination Half-Life (t1/2)</measure>
    <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Cigarettes Smoked Daily During Treatment and at Day 26</measure>
    <time_frame>Day 1 through Day 26</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26</measure>
    <time_frame>Baseline, Day 1 through Day 26</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in Expired Air CO up to Day 26</measure>
    <time_frame>Baseline, Days 4, 13, 17, 21, 26</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Ceased or Continued Smoking on Day 26</measure>
    <time_frame>Day 26</time_frame>
    <description>A status of &quot;ceased smoking&quot; is defined as not having smoked any cigarettes for the past 24 hours on Day 26 and having an expired CO level &lt;10 ppm on Day 26.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline Over Time in Urine Cotinine</measure>
    <time_frame>Baseline, Days 4, 13, 17, 21, 26</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline Over Time in TCQ-SF Score: Emotionality</measure>
    <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
    <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Emotionality scores may range from 3 to 21, with lower scores indicating weaker emotional signs of tobacco craving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline Over Time in TCQ-SF Score: Expectancy</measure>
    <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
    <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Expectancy scores may range from 3 to 21, with lower scores indicating less positive expectations about smoking.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline Over Time in TCQ-SF Score: Compulsivity</measure>
    <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
    <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly agree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Compulsivity scores may range from 3 to 21, with lower scores indicating compulsion to smoke was a lesser component of tobacco craving.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline Over Time in TCQ-SF Score: Purposefulness</measure>
    <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
    <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Purposefulness scores may range from 3 to 21, with lower scores indicating stronger ability to not smoke.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline Over Time in TCQ-SF Score: Total Score</measure>
    <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
    <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Total scores may range from 12 to 84, with lower scores indicating lower tobacco craving.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytisine Amount Excreted in Urine Over Time (Ae0-24h)</measure>
    <time_frame>Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Drug Excreted in Urine (Ae%)</measure>
    <time_frame>Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to TEAEs</measure>
    <time_frame>From first dose of study drug through Day 26 plus 6-8 days</time_frame>
    <description>An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an AE that results in any of the following: results in death; is life-threatening; requires hospitalisation or prolongs existing inpatient's hospitalisation; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes.TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Values in Biochemistry, Hematology, and Urinalysis</measure>
    <time_frame>up to Day 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Values in Vital Signs and Physical Examinations</measure>
    <time_frame>up to Day 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters</measure>
    <time_frame>up to Day 26</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Holter ECG Outlier Values</measure>
    <time_frame>on Day 1 and Day 25 at 30 and 15 minutes prior to the first dose and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post dose</time_frame>
    <description>Based on the mean of the triplicate recordings at each time point. Increase (↑)/decrease (↓) calculated from Baseline (BL), defined as the mean of all recordings taken prior to dosing on Day 1 (i.e. -30 minutes and -15 minutes). A participant with multiple occurrences of an event is counted only once per event.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Cytisine 1.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cytisine 3.0 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytisine</intervention_name>
    <description>film-coated tablets; depending on arm assignment, 1 or 2 tablets to be taken with 240 mL water for each dose</description>
    <arm_group_label>Cytisine 1.5 mg</arm_group_label>
    <arm_group_label>Cytisine 3.0 mg</arm_group_label>
    <other_name>Tabex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Regular moderate cigarette smokers (minimum 10 cigarettes per day) who want to stop&#xD;
             smoking.&#xD;
&#xD;
          2. Urine cotinine &gt;500 ng/mL.&#xD;
&#xD;
          3. Expired air carbon monoxide (CO) &gt; 11 parts per million (no cigarette 1 hour before&#xD;
             test).&#xD;
&#xD;
          4. Healthy males and females 18-65+ years of age.&#xD;
&#xD;
               1. If a female subject of child bearing potential, a negative pregnancy test at&#xD;
                  screening and admission and willing to use an effective method of contraception&#xD;
                  (unless of non-childbearing potential or where abstaining from sexual intercourse&#xD;
                  is in line with the preferred and usual lifestyle of the subject) from first dose&#xD;
                  until 3 months after last dose of cytisine.&#xD;
&#xD;
               2. If a female subject of non-child bearing potential, a negative pregnancy test at&#xD;
                  screening and admission. For the purposes of this study, this is defined as the&#xD;
                  subject being amenorrheic for at least 12 consecutive months or at least 4 months&#xD;
                  post-surgical sterilisation (including bilateral fallopian tube ligation or&#xD;
                  bilateral oophorectomy with or without hysterectomy). Menopausal status will be&#xD;
                  confirmed by demonstrating at screening that levels of follicle stimulating&#xD;
                  hormone (FSH) fall within the respective pathology reference range. In the event&#xD;
                  a subject's menopause status has been clearly established (for example, the&#xD;
                  subject indicates she has been amenorrheic for 10 years), but FSH levels are not&#xD;
                  consistent with a post-menopausal condition, determination of subject eligibility&#xD;
                  will be at Investigator's discretion following consultation with the Sponsor.&#xD;
&#xD;
               3. If a male subject, willing to use an effective method of contraception (unless&#xD;
                  anatomically sterile or where abstaining from sexual intercourse is in line with&#xD;
                  the preferred and usual lifestyle of the subject) from first dose until 3 months&#xD;
                  after last dose of cytisine.&#xD;
&#xD;
          5. Subject with no clinically significant abnormal serum biochemistry, haematology and&#xD;
             urine examination values within 28 days before the first dose of cytisine.&#xD;
&#xD;
          6. Subject with negative urinary drugs of abuse screen, determined within 28 days before&#xD;
             the first dose of cytisine (a positive alcohol result may be repeated at&#xD;
             Investigator's discretion).&#xD;
&#xD;
          7. Subject with negative human immunodeficiency virus (HIV), hepatitis B surface antigen&#xD;
             (Hep B) and hepatitis C virus antibody (Hep C) results.&#xD;
&#xD;
          8. Subject with no clinically significant abnormalities in 12-lead ECG determined after&#xD;
             minimum of 5 minutes in supine position within 28 days before the first dose of&#xD;
             cytisine.&#xD;
&#xD;
          9. Subject with no clinically significant abnormalities in vital signs (systolic blood&#xD;
             pressure between 90-150 mmHg (age 18-65) and 90-160 mmHg (age &gt;65), diastolic blood&#xD;
             pressure (DBP) between 50 and 90 mmHg, and pulse rate (PR) between 40 110 bpm,&#xD;
             measured on the dominant arm after minimum of 5 minutes in supine position) determined&#xD;
             within 28 days before first dose of cytisine.&#xD;
&#xD;
         10. Subject must be available to complete the study (including in-clinic stays and post&#xD;
             study follow-up) and comply with study restrictions.&#xD;
&#xD;
         11. Subject must provide written informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment with smoking cessation medications (bupropion, varenicline, any nicotine&#xD;
             replacement therapy) within 8 weeks of first dose of cytisine.&#xD;
&#xD;
          2. Use of other forms of nicotine (e-cigarettes, smokeless tobacco) within 8 weeks of&#xD;
             first dose of cytisine or are planning to use these products during study.&#xD;
&#xD;
          3. Known hypersensitivity/allergy reaction to varenicline, other cytisine-derivatives or&#xD;
             any of the excipients in the Tabex formulation.&#xD;
&#xD;
          4. History of severe hypersensitivity reactions to any other drugs.&#xD;
&#xD;
          5. Current treatment with antihypertensive medicinal products, statins, tuberculostatics,&#xD;
             cholinomimetics or anticholinesterase medicinal products.&#xD;
&#xD;
          6. History of any medical condition (e.g. gastrointestinal, renal or hepatic) or surgical&#xD;
             condition (e.g. cholecystectomy, gastrectomy) that may affect drug pharmacokinetics&#xD;
             (absorption, distribution, metabolism or excretion).&#xD;
&#xD;
          7. Female subjects who are breast feeding.&#xD;
&#xD;
          8. Difficulty in donating blood on either arm or known history.&#xD;
&#xD;
          9. History of alcoholism or drug abuse within last 2 years.&#xD;
&#xD;
         10. Use of non-prescription drugs, including vitamins, herbal and dietary supplements&#xD;
             within 14 days (or 5 half-lives, whichever is longer) prior to the first dose of&#xD;
             cytisine, unless in the opinion of the Principal Investigator the medication will not&#xD;
             interfere with the study procedures or compromise subject safety.&#xD;
&#xD;
         11. Participated in any investigational drug clinical trial within the previous 3 months&#xD;
             or a marketed drug trial within the previous 30 days prior to randomisation on Day 1.&#xD;
&#xD;
         12. Donation of 450 mL or more blood or had history of significant blood loss due to any&#xD;
             reason or had plasmapheresis within 3 months before the first dose of cytisine.&#xD;
&#xD;
         13. Inability to communicate well with Principal Investigator or designees (i.e., language&#xD;
             problem, poor mental development or impaired cerebral function).&#xD;
&#xD;
         14. Any other condition that the Principal Investigator considers making the subject&#xD;
             unsuitable for this 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>
  <overall_official>
    <last_name>Annelize Koch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Simbec Research Ltd (Simbec)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Simbec Research Ltd</name>
      <address>
        <city>Cardiff</city>
        <zip>CF11 9AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>September 22, 2019</results_first_submitted>
  <results_first_submitted_qc>October 17, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 21, 2019</results_first_posted>
  <last_update_submitted>October 17, 2019</last_update_submitted>
  <last_update_submitted_qc>October 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03303911/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03303911/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cytisine 1.5 mg</title>
          <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
        </group>
        <group group_id="P2">
          <title>Cytisine 3.0 mg</title>
          <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cytisine 1.5 mg</title>
          <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
        </group>
        <group group_id="B2">
          <title>Cytisine 3.0 mg</title>
          <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.0" spread="12.87"/>
                    <measurement group_id="B2" value="40.9" spread="12.94"/>
                    <measurement group_id="B3" value="39.0" spread="12.80"/>
                  </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="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other, Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Expired Carbon Monoxide (CO) at Screening</title>
          <units>ppm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.0" spread="8.02"/>
                    <measurement group_id="B2" value="20.7" spread="6.76"/>
                    <measurement group_id="B3" value="20.8" spread="7.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urine Cotinine at Screening</title>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1661.0" spread="502.57"/>
                    <measurement group_id="B2" value="1944.2" spread="611.61"/>
                    <measurement group_id="B3" value="1802.6" spread="567.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Cigarettes Smoked in the Past 24 hours on Day -1</title>
          <units>cigarettes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.31" spread="3.401"/>
                    <measurement group_id="B2" value="18.08" spread="5.171"/>
                    <measurement group_id="B3" value="17.19" spread="4.382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tobacco Craving Questionnaire - Short Form (TCQ-SF) Emotionality Score at Day -1</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Emotionality scores may range from 3 to 21, with lower scores indicating weaker emotional signs of tobacco craving.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.9" spread="5.25"/>
                    <measurement group_id="B2" value="11.7" spread="5.28"/>
                    <measurement group_id="B3" value="11.3" spread="5.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>TCQ-SF Expectancy Score at Day -1</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Expectancy scores may range from 3 to 21, with lower scores indicating less positive expectations about smoking.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.4" spread="5.19"/>
                    <measurement group_id="B2" value="14.0" spread="6.47"/>
                    <measurement group_id="B3" value="12.7" spread="5.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>TCQ-SF Compulsivity Score at Day -1</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly agree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Compulsivity scores may range from 3 to 21, with lower scores indicating compulsion to smoke was a lesser component of tobacco craving.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.5" spread="4.61"/>
                    <measurement group_id="B2" value="9.5" spread="4.33"/>
                    <measurement group_id="B3" value="9.5" spread="4.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>TCQ-SF Purposefulness Score at Day -1</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Purposefulness scores may range from 3 to 21, with lower scores indicating stronger ability to not smoke.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.9" spread="3.57"/>
                    <measurement group_id="B2" value="15.6" spread="5.27"/>
                    <measurement group_id="B3" value="15.3" spread="4.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>TCQ-SF Total Score at Day -1</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Total scores may range from 12 to 84, with lower scores indicating lower tobacco craving.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.7" spread="12.96"/>
                    <measurement group_id="B2" value="50.8" spread="16.89"/>
                    <measurement group_id="B3" value="48.7" spread="14.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerström Test for Nicotine Dependence Total Score at Day -1</title>
          <description>The Fagerström Nicotine Dependence Questionnaire (FTND) is a measure of nicotine dependence. The FTND total score is defined as the sum of the scores from 6 questions, provided all 6 questions have been completed. The FTND responses are assigned numerical values. Total Scores may range from 1 to10, with lower scores indicating less dependence on nicotine..</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.7" spread="1.60"/>
                    <measurement group_id="B2" value="5.3" spread="1.38"/>
                    <measurement group_id="B3" value="5.0" spread="1.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax)</title>
        <time_frame>after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25</time_frame>
        <population>Pharmacokinetic (PK) Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax)</title>
          <population>Pharmacokinetic (PK) Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given timepoint.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, first dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" spread="24.8"/>
                    <measurement group_id="O2" value="40.0" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.8" spread="20.0"/>
                    <measurement group_id="O2" value="81.4" spread="30.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.9" spread="22.3"/>
                    <measurement group_id="O2" value="85.1" spread="20.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" spread="21.7"/>
                    <measurement group_id="O2" value="88.1" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.9" spread="24.9"/>
                    <measurement group_id="O2" value="69.9" spread="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="31.4"/>
                    <measurement group_id="O2" value="50.5" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" spread="22.1"/>
                    <measurement group_id="O2" value="49.7" spread="30.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" spread="28.3"/>
                    <measurement group_id="O2" value="42.0" spread="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" spread="19.4"/>
                    <measurement group_id="O2" value="28.1" spread="27.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time of Occurrence of Cmax (Tmax)</title>
        <time_frame>after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25</time_frame>
        <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Occurrence of Cmax (Tmax)</title>
          <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given time point.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1, first dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.500" upper_limit="0.750"/>
                    <measurement group_id="O2" value="0.750" lower_limit="0.500" upper_limit="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.00" upper_limit="2.50"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.00" upper_limit="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.00" upper_limit="3.50"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.00" upper_limit="3.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.500" upper_limit="3.00"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.00" upper_limit="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.00" upper_limit="3.05"/>
                    <measurement group_id="O2" value="1.02" lower_limit="0.00" upper_limit="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="0.00" upper_limit="4.02"/>
                    <measurement group_id="O2" value="2.00" lower_limit="1.00" upper_limit="6.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" lower_limit="1.00" upper_limit="5.50"/>
                    <measurement group_id="O2" value="1.00" lower_limit="0.00" upper_limit="6.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24, last dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="1.00" lower_limit="1.00" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="0.500" upper_limit="5.00"/>
                    <measurement group_id="O2" value="2.25" lower_limit="0.500" upper_limit="3.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Minimum Observed Plasma Concentration (Cmin)</title>
        <time_frame>after the first dose on Days 4, 13, 17, 21 and 25</time_frame>
        <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Observed Plasma Concentration (Cmin)</title>
          <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment at given timepoint.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4, first dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.36" spread="47.7"/>
                    <measurement group_id="O2" value="13.2" spread="27.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13, first dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.16" spread="48.2"/>
                    <measurement group_id="O2" value="12.6" spread="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17, first dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.19" spread="64.7"/>
                    <measurement group_id="O2" value="8.50" spread="38.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21, first dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.13" spread="83.4"/>
                    <measurement group_id="O2" value="6.34" spread="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.16" spread="188.9"/>
                    <measurement group_id="O2" value="3.74" spread="42.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time (AUC0-t)</title>
        <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
        <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time (AUC0-t)</title>
          <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.0" spread="27.4"/>
                    <measurement group_id="O2" value="185" spread="32.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total AUC From Time Zero to Infinity (AUC0-∞)</title>
        <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
        <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Total AUC From Time Zero to Infinity (AUC0-∞)</title>
          <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.6" spread="30.4"/>
                    <measurement group_id="O2" value="213" spread="28.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Residual Area or Percentage of Extrapolated Part for the Calculation of AUC0-∞ (%AUC)</title>
        <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
        <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Area or Percentage of Extrapolated Part for the Calculation of AUC0-∞ (%AUC)</title>
          <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
          <units>percentage of extrapolated part</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0" spread="28.9"/>
                    <measurement group_id="O2" value="11.7" spread="40.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Terminal Elimination Rate Constant (λz)</title>
        <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
        <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Elimination Rate Constant (λz)</title>
          <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
          <units>1/hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.185" spread="26.4"/>
                    <measurement group_id="O2" value="0.152" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Apparent Terminal Elimination Half-Life (t1/2)</title>
        <time_frame>after the administration of the final dose of cytisine on Day 25</time_frame>
        <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Elimination Half-Life (t1/2)</title>
          <population>PK Set: All randomized participants who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria. Participants with an assessment.</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.75" spread="24.7"/>
                    <measurement group_id="O2" value="4.57" spread="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Cigarettes Smoked Daily During Treatment and at Day 26</title>
        <time_frame>Day 1 through Day 26</time_frame>
        <population>Pharmacodynamic (PD) Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation. Participants with a valid assessment at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cigarettes Smoked Daily During Treatment and at Day 26</title>
          <population>Pharmacodynamic (PD) Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation. Participants with a valid assessment at given time point.</population>
          <units>cigarettes smoked in the past 24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day -1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.31" spread="3.401"/>
                    <measurement group_id="O2" value="18.08" spread="5.171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.31" spread="6.088"/>
                    <measurement group_id="O2" value="8.77" spread="6.882"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.69" spread="1.437"/>
                    <measurement group_id="O2" value="4.08" spread="1.801"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="1.673"/>
                    <measurement group_id="O2" value="4.46" spread="1.854"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.77" spread="2.682"/>
                    <measurement group_id="O2" value="6.15" spread="3.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.08" spread="2.629"/>
                    <measurement group_id="O2" value="5.69" spread="3.568"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.85" spread="3.826"/>
                    <measurement group_id="O2" value="7.00" spread="4.778"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.19" spread="4.018"/>
                    <measurement group_id="O2" value="4.85" spread="4.180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.15" spread="3.760"/>
                    <measurement group_id="O2" value="5.38" spread="4.073"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.77" spread="4.438"/>
                    <measurement group_id="O2" value="5.08" spread="4.555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.62" spread="4.234"/>
                    <measurement group_id="O2" value="4.54" spread="4.557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.81" spread="3.497"/>
                    <measurement group_id="O2" value="4.62" spread="4.292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.31" spread="3.545"/>
                    <measurement group_id="O2" value="3.69" spread="3.637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.15" spread="4.038"/>
                    <measurement group_id="O2" value="5.00" spread="4.163"/>
                  </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="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="3.786"/>
                    <measurement group_id="O2" value="3.69" spread="4.535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.23" spread="3.876"/>
                    <measurement group_id="O2" value="3.62" spread="4.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.85" spread="3.648"/>
                    <measurement group_id="O2" value="3.08" spread="3.451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="4.163"/>
                    <measurement group_id="O2" value="3.77" spread="4.781"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.69" spread="3.903"/>
                    <measurement group_id="O2" value="3.92" spread="4.873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.69" spread="3.881"/>
                    <measurement group_id="O2" value="3.54" spread="4.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.25" spread="3.671"/>
                    <measurement group_id="O2" value="2.58" spread="3.528"/>
                  </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="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.54" spread="4.719"/>
                    <measurement group_id="O2" value="2.92" spread="4.462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" spread="4.163"/>
                    <measurement group_id="O2" value="3.00" spread="3.958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.38" spread="4.407"/>
                    <measurement group_id="O2" value="2.69" spread="4.151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.08" spread="2.985"/>
                    <measurement group_id="O2" value="2.38" spread="3.042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.17" spread="1.467"/>
                    <measurement group_id="O2" value="0.85" spread="1.214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.23" spread="4.206"/>
                    <measurement group_id="O2" value="3.00" spread="4.778"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26</title>
        <time_frame>Baseline, Day 1 through Day 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation. Participants with a valid assessment at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26</title>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation. Participants with a valid assessment at given time point.</population>
          <units>cigarettes smoked in the past 24 hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.00" spread="5.745"/>
                    <measurement group_id="O2" value="-9.31" spread="7.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.62" spread="3.664"/>
                    <measurement group_id="O2" value="-14.00" spread="5.000"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.91" spread="3.885"/>
                    <measurement group_id="O2" value="-13.62" spread="5.723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.54" spread="4.737"/>
                    <measurement group_id="O2" value="-11.92" spread="6.144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.23" spread="4.475"/>
                    <measurement group_id="O2" value="-12.38" spread="5.665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.46" spread="4.371"/>
                    <measurement group_id="O2" value="-11.08" spread="7.005"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.12" spread="4.718"/>
                    <measurement group_id="O2" value="-13.23" spread="5.388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.15" spread="4.580"/>
                    <measurement group_id="O2" value="-12.69" spread="5.391"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.54" spread="5.333"/>
                    <measurement group_id="O2" value="-13.00" spread="5.845"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.69" spread="4.697"/>
                    <measurement group_id="O2" value="-13.54" spread="5.425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.50" spread="4.173"/>
                    <measurement group_id="O2" value="-13.46" spread="4.789"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.00" spread="4.813"/>
                    <measurement group_id="O2" value="-14.38" spread="4.992"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.15" spread="4.543"/>
                    <measurement group_id="O2" value="-13.08" spread="6.873"/>
                  </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="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.31" spread="4.309"/>
                    <measurement group_id="O2" value="-14.38" spread="6.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.08" spread="4.212"/>
                    <measurement group_id="O2" value="-14.46" spread="5.592"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.46" spread="3.597"/>
                    <measurement group_id="O2" value="-15.00" spread="5.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.31" spread="4.768"/>
                    <measurement group_id="O2" value="-14.31" spread="5.721"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.62" spread="4.753"/>
                    <measurement group_id="O2" value="-14.15" spread="6.012"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 19</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.62" spread="4.556"/>
                    <measurement group_id="O2" value="-14.54" spread="5.577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.17" spread="3.810"/>
                    <measurement group_id="O2" value="-15.83" spread="4.569"/>
                  </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="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.77" spread="5.262"/>
                    <measurement group_id="O2" value="-15.15" spread="5.535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.31" spread="4.404"/>
                    <measurement group_id="O2" value="-15.08" spread="5.251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 23</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.92" spread="4.873"/>
                    <measurement group_id="O2" value="-15.38" spread="5.091"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.23" spread="4.419"/>
                    <measurement group_id="O2" value="-15.69" spread="4.461"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.83" spread="3.407"/>
                    <measurement group_id="O2" value="-17.23" spread="4.850"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.08" spread="4.645"/>
                    <measurement group_id="O2" value="-15.08" spread="4.387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Expired Air CO up to Day 26</title>
        <time_frame>Baseline, Days 4, 13, 17, 21, 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Expired Air CO up to Day 26</title>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
          <units>ppm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.2" spread="8.34"/>
                    <measurement group_id="O2" value="-13.8" spread="7.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.3" spread="8.02"/>
                    <measurement group_id="O2" value="-15.9" spread="6.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.0" spread="7.93"/>
                    <measurement group_id="O2" value="-16.2" spread="5.81"/>
                  </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="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.4" spread="7.79"/>
                    <measurement group_id="O2" value="-16.5" spread="6.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.2" spread="8.33"/>
                    <measurement group_id="O2" value="-17.9" spread="6.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Ceased or Continued Smoking on Day 26</title>
        <description>A status of &quot;ceased smoking&quot; is defined as not having smoked any cigarettes for the past 24 hours on Day 26 and having an expired CO level &lt;10 ppm on Day 26.</description>
        <time_frame>Day 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Ceased or Continued Smoking on Day 26</title>
          <description>A status of &quot;ceased smoking&quot; is defined as not having smoked any cigarettes for the past 24 hours on Day 26 and having an expired CO level &lt;10 ppm on Day 26.</description>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Ceased Smoking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Continued Smoking</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Over Time in Urine Cotinine</title>
        <time_frame>Baseline, Days 4, 13, 17, 21, 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over Time in Urine Cotinine</title>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</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="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1040.8" spread="579.78"/>
                    <measurement group_id="O2" value="-1339.2" spread="550.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1010.0" spread="797.78"/>
                    <measurement group_id="O2" value="-1309.3" spread="761.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1012.1" spread="710.39"/>
                    <measurement group_id="O2" value="-1405.2" spread="814.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1095.1" spread="679.81"/>
                    <measurement group_id="O2" value="-1446.3" spread="828.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1362.2" spread="545.84"/>
                    <measurement group_id="O2" value="-1640.2" spread="688.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Over Time in TCQ-SF Score: Emotionality</title>
        <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Emotionality scores may range from 3 to 21, with lower scores indicating weaker emotional signs of tobacco craving.</description>
        <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over Time in TCQ-SF Score: Emotionality</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Emotionality scores may range from 3 to 21, with lower scores indicating weaker emotional signs of tobacco craving.</description>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.2" spread="5.40"/>
                    <measurement group_id="O2" value="-6.0" spread="5.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" spread="5.96"/>
                    <measurement group_id="O2" value="-7.2" spread="4.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="6.12"/>
                    <measurement group_id="O2" value="-7.3" spread="5.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="6.38"/>
                    <measurement group_id="O2" value="-7.6" spread="5.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.7" spread="7.00"/>
                    <measurement group_id="O2" value="-8.2" spread="4.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Over Time in TCQ-SF Score: Expectancy</title>
        <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Expectancy scores may range from 3 to 21, with lower scores indicating less positive expectations about smoking.</description>
        <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results. Participants with an assessment at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over Time in TCQ-SF Score: Expectancy</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Expectancy scores may range from 3 to 21, with lower scores indicating less positive expectations about smoking.</description>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results. Participants with an assessment at given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.8" spread="5.89"/>
                    <measurement group_id="O2" value="-8.0" spread="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="7.83"/>
                    <measurement group_id="O2" value="-8.4" spread="5.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="6.96"/>
                    <measurement group_id="O2" value="-8.8" spread="5.82"/>
                  </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="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.2" spread="6.56"/>
                    <measurement group_id="O2" value="-9.2" spread="5.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.2" spread="6.40"/>
                    <measurement group_id="O2" value="-9.8" spread="6.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Over Time in TCQ-SF Score: Compulsivity</title>
        <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly agree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Compulsivity scores may range from 3 to 21, with lower scores indicating compulsion to smoke was a lesser component of tobacco craving.</description>
        <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over Time in TCQ-SF Score: Compulsivity</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly agree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Compulsivity scores may range from 3 to 21, with lower scores indicating compulsion to smoke was a lesser component of tobacco craving.</description>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.2" spread="3.18"/>
                    <measurement group_id="O2" value="-3.5" spread="4.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" spread="6.56"/>
                    <measurement group_id="O2" value="-4.9" spread="4.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="6.32"/>
                    <measurement group_id="O2" value="-5.2" spread="4.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="5.49"/>
                    <measurement group_id="O2" value="-5.3" spread="4.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.3" spread="5.94"/>
                    <measurement group_id="O2" value="-5.8" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Over Time in TCQ-SF Score: Purposefulness</title>
        <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Purposefulness scores may range from 3 to 21, with lower scores indicating stronger ability to not smoke.</description>
        <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over Time in TCQ-SF Score: Purposefulness</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Purposefulness scores may range from 3 to 21, with lower scores indicating stronger ability to not smoke.</description>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.5" spread="2.93"/>
                    <measurement group_id="O2" value="-7.5" spread="4.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.6" spread="6.34"/>
                    <measurement group_id="O2" value="-9.1" spread="5.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.6" spread="6.33"/>
                    <measurement group_id="O2" value="-9.2" spread="6.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.8" spread="6.48"/>
                    <measurement group_id="O2" value="-10.3" spread="5.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.0" spread="5.15"/>
                    <measurement group_id="O2" value="-11.1" spread="5.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Over Time in TCQ-SF Score: Total Score</title>
        <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Total scores may range from 12 to 84, with lower scores indicating lower tobacco craving.</description>
        <time_frame>Baseline (Day -1), Days 4, 13, 17, 21, 26</time_frame>
        <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results. Participants with an assessment at given time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Over Time in TCQ-SF Score: Total Score</title>
          <description>The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Total scores may range from 12 to 84, with lower scores indicating lower tobacco craving.</description>
          <population>PD Set: All participants in the PK set who had an available baseline result and at least 1 on-treatment result with regards to urine cotinine, expired air CO or daily cigarette consumption and did not incur a major protocol deviation in a way that may have invalidated or biased the PD results. Participants with an assessment at given time point.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.7" spread="12.88"/>
                    <measurement group_id="O2" value="-26.0" spread="16.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.7" spread="22.11"/>
                    <measurement group_id="O2" value="-29.6" spread="16.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.5" spread="22.17"/>
                    <measurement group_id="O2" value="-30.5" spread="16.51"/>
                  </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="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.2" spread="21.79"/>
                    <measurement group_id="O2" value="-32.5" spread="16.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.2" spread="20.55"/>
                    <measurement group_id="O2" value="-34.8" spread="16.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cytisine Amount Excreted in Urine Over Time (Ae0-24h)</title>
        <time_frame>Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25</time_frame>
        <population>PK Set: All randomized subjects who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Cytisine Amount Excreted in Urine Over Time (Ae0-24h)</title>
          <population>PK Set: All randomized subjects who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria.</population>
          <units>mg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.95" spread="14.3"/>
                    <measurement group_id="O2" value="16.5" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="17.4"/>
                    <measurement group_id="O2" value="3.14" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Drug Excreted in Urine (Ae%)</title>
        <time_frame>Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25</time_frame>
        <population>PK Set: All randomized subjects who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Drug Excreted in Urine (Ae%)</title>
          <population>PK Set: All randomized subjects who completed all cytisine dosing on Days 1-3, completed &gt;90% cytisine dosing on Days 4-25 and complied with protocol-specified criteria.</population>
          <units>percentage of excreted drug</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.3" spread="14.3"/>
                    <measurement group_id="O2" value="91.6" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102" spread="17.4"/>
                    <measurement group_id="O2" value="105" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to TEAEs</title>
        <description>An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an AE that results in any of the following: results in death; is life-threatening; requires hospitalisation or prolongs existing inpatient's hospitalisation; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes.TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.</description>
        <time_frame>From first dose of study drug through Day 26 plus 6-8 days</time_frame>
        <population>Safety Set: all randomized participants who received at least one dose of cytisine.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to TEAEs</title>
          <description>An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an AE that results in any of the following: results in death; is life-threatening; requires hospitalisation or prolongs existing inpatient's hospitalisation; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes.TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.</description>
          <population>Safety Set: all randomized participants who received at least one dose of cytisine.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discontinuation of Study Drug due to TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Values in Biochemistry, Hematology, and Urinalysis</title>
        <time_frame>up to Day 26</time_frame>
        <population>Safety Set: all randomized participants who received at least one dose of cytisine.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Values in Biochemistry, Hematology, and Urinalysis</title>
          <population>Safety Set: all randomized participants who received at least one dose of cytisine.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Biochemistry</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinalysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Values in Vital Signs and Physical Examinations</title>
        <time_frame>up to Day 26</time_frame>
        <population>Safety Set: all randomized participants who received at least one dose of cytisine.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Values in Vital Signs and Physical Examinations</title>
          <population>Safety Set: all randomized participants who received at least one dose of cytisine.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Vital Signs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Examinations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters</title>
        <time_frame>up to Day 26</time_frame>
        <population>ECG Set: all participants who received at least 1 dose of cytisine, with at least 1 available baseline ECG and at least 1 on-treatment ECG.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters</title>
          <population>ECG Set: all participants who received at least 1 dose of cytisine, with at least 1 available baseline ECG and at least 1 on-treatment ECG.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Holter ECG Outlier Values</title>
        <description>Based on the mean of the triplicate recordings at each time point. Increase (↑)/decrease (↓) calculated from Baseline (BL), defined as the mean of all recordings taken prior to dosing on Day 1 (i.e. -30 minutes and -15 minutes). A participant with multiple occurrences of an event is counted only once per event.</description>
        <time_frame>on Day 1 and Day 25 at 30 and 15 minutes prior to the first dose and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post dose</time_frame>
        <population>ECG Set: all participants who received at least 1 dose of cytisine, with at least 1 available baseline ECG and at least 1 on-treatment ECG.</population>
        <group_list>
          <group group_id="O1">
            <title>Cytisine 1.5 mg</title>
            <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
          <group group_id="O2">
            <title>Cytisine 3.0 mg</title>
            <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Holter ECG Outlier Values</title>
          <description>Based on the mean of the triplicate recordings at each time point. Increase (↑)/decrease (↓) calculated from Baseline (BL), defined as the mean of all recordings taken prior to dosing on Day 1 (i.e. -30 minutes and -15 minutes). A participant with multiple occurrences of an event is counted only once per event.</description>
          <population>ECG Set: all participants who received at least 1 dose of cytisine, with at least 1 available baseline ECG and at least 1 on-treatment ECG.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: Heart Rate &lt;50 bpm &amp; ↓ ≥ 25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: Heart Rate &gt;100 bpm &amp; ↑ ≥25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: PR Interval &gt;200 mSec &amp; ↑ ≥25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: QRS Duration &gt;100 mSec &amp; ↑ ≥25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: QT Interval &gt;500 mSec &amp; BL ≤500 mSec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: QTcF Interval &gt;500 mSec &amp; BL ≤500 mSec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: QTcF Interval &gt;480 mSec &amp; BL ≤480 mSec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: QTcF Interval &gt;450 mSec &amp; BL ≤450 mSec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25: Heart Rate &lt;50 bpm &amp; ↓ ≥ 25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25: Heart Rate &gt;100 bpm &amp; ↑ ≥25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25: PR Interval &gt;200 mSec &amp; ↑ ≥25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25: QRS Duration &gt;100 mSec &amp; ↑ ≥25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25: QT Interval &gt;500 mSec &amp; BL ≤500 mSec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25: QTcF Interval &gt;500 mSec &amp; BL ≤500 mSec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25: QTcF Interval &gt;480 mSec &amp; BL ≤480 mSec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 25: QTcF Interval &gt;450 mSec &amp; BL ≤450 mSec</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug through Day 26 plus 6-8 days</time_frame>
      <desc>TEAEs are presented. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cytisine 1.5 mg</title>
          <description>Multiple doses of 1.5 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
        </group>
        <group group_id="E2">
          <title>Cytisine 3.0 mg</title>
          <description>Multiple doses of 3.0 mg cytisine administered per 25-day schedule:&#xD;
Days 1-3 (6 times daily)&#xD;
Days 4-12 (5 times daily)&#xD;
Days 13-16 (4 times daily)&#xD;
Days 17-20 (3 times daily)&#xD;
Days 21-24 (2 times daily)&#xD;
Day 25 (Once daily)</description>
        </group>
      </group_list>
      <serious_events>
        <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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1.</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Tooth loss</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Medical device site reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sinonasal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </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>Principal Investigators are bound by requirements outlined in their individual clinical trial agreements with regard to publication of trial results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Daniel Cain, Vice President, Clinical Research</name_or_title>
      <organization>Achieve Life Sciences</organization>
      <phone>425.686.1546</phone>
      <email>dcain@achievelifesciences.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03303911
org study id: ACH-CYT-02
nct id: NCT03303911
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The primary objectives of this study are:

        -  To evaluate the pharmacokinetic (PK) parameters during repeat dosing of 1.5 mg or 3.0 mg
           cytisine when administered as the commercial 25-day schedule.

        -  To evaluate the pharmacodynamic (PD) effects (e.g., reduction in smoking) with repeat
           dosing of 1.5 mg or 3.0 mg cytisine when administered as the commercial 25-day schedule.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25
measure: Time of Occurrence of Cmax (Tmax)
time frame: after the first dose and the last dose on Day 1; after the last dose on Days 2, 3, 12, 16, 20, 24; and after the morning dose on Day 25
measure: Minimum Observed Plasma Concentration (Cmin)
time frame: after the first dose on Days 4, 13, 17, 21 and 25
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time Zero to the Last Sampling Time (AUC0-t)
time frame: after the administration of the final dose of cytisine on Day 25
measure: Total AUC From Time Zero to Infinity (AUC0-∞)
time frame: after the administration of the final dose of cytisine on Day 25
measure: Residual Area or Percentage of Extrapolated Part for the Calculation of AUC0-∞ (%AUC)
time frame: after the administration of the final dose of cytisine on Day 25
measure: Apparent Terminal Elimination Rate Constant (λz)
time frame: after the administration of the final dose of cytisine on Day 25
measure: Apparent Terminal Elimination Half-Life (t1/2)
time frame: after the administration of the final dose of cytisine on Day 25
measure: Number of Cigarettes Smoked Daily During Treatment and at Day 26
time frame: Day 1 through Day 26
measure: Change From Baseline in Number of Cigarettes Smoked Daily up to Day 26
time frame: Baseline, Day 1 through Day 26
measure: Change From Baseline in Expired Air CO up to Day 26
time frame: Baseline, Days 4, 13, 17, 21, 26
measure: Number of Participants Who Ceased or Continued Smoking on Day 26
time frame: Day 26
description: A status of "ceased smoking" is defined as not having smoked any cigarettes for the past 24 hours on Day 26 and having an expired CO level <10 ppm on Day 26.
measure: Change From Baseline Over Time in Urine Cotinine
time frame: Baseline, Days 4, 13, 17, 21, 26
measure: Change From Baseline Over Time in TCQ-SF Score: Emotionality
time frame: Baseline (Day -1), Days 4, 13, 17, 21, 26
description: The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Emotionality scores may range from 3 to 21, with lower scores indicating weaker emotional signs of tobacco craving.
measure: Change From Baseline Over Time in TCQ-SF Score: Expectancy
time frame: Baseline (Day -1), Days 4, 13, 17, 21, 26
description: The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Expectancy scores may range from 3 to 21, with lower scores indicating less positive expectations about smoking.
measure: Change From Baseline Over Time in TCQ-SF Score: Compulsivity
time frame: Baseline (Day -1), Days 4, 13, 17, 21, 26
description: The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly agree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Compulsivity scores may range from 3 to 21, with lower scores indicating compulsion to smoke was a lesser component of tobacco craving.
measure: Change From Baseline Over Time in TCQ-SF Score: Purposefulness
time frame: Baseline (Day -1), Days 4, 13, 17, 21, 26
description: The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Purposefulness scores may range from 3 to 21, with lower scores indicating stronger ability to not smoke.
measure: Change From Baseline Over Time in TCQ-SF Score: Total Score
time frame: Baseline (Day -1), Days 4, 13, 17, 21, 26
description: The TCQ-SF is a 12-item questionnaire that assesses 4 components of tobacco craving: emotionality (3 items), expectancy (3 items), compulsivity (3 items) and purposefulness (3 items). Responses to each item are scored from 1 (strongly disagree) through 7 (strongly disagree). Component scores are defined as the sum of the scores within each component. The total score is defined as the sum of the 4 component scores. Total scores may range from 12 to 84, with lower scores indicating lower tobacco craving.
measure: Cytisine Amount Excreted in Urine Over Time (Ae0-24h)
time frame: Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25
measure: Percent of Drug Excreted in Urine (Ae%)
time frame: Day 1 (6 times daily at 2-hour intervals); after the administration of the single dose of cytisine on Day 25
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to TEAEs
time frame: From first dose of study drug through Day 26 plus 6-8 days
description: An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) is defined as an AE that results in any of the following: results in death; is life-threatening; requires hospitalisation or prolongs existing inpatient's hospitalisation; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes.TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of investigational product that worsen after the participant receives the first dose of investigational product.
measure: Number of Participants With Clinically Significant Values in Biochemistry, Hematology, and Urinalysis
time frame: up to Day 26
measure: Number of Participants With Clinically Significant Values in Vital Signs and Physical Examinations
time frame: up to Day 26
measure: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Parameters
time frame: up to Day 26
measure: Number of Participants With Holter ECG Outlier Values
time frame: on Day 1 and Day 25 at 30 and 15 minutes prior to the first dose and 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours post dose
description: Based on the mean of the triplicate recordings at each time point. Increase (↑)/decrease (↓) calculated from Baseline (BL), defined as the mean of all recordings taken prior to dosing on Day 1 (i.e. -30 minutes and -15 minutes). A participant with multiple occurrences of an event is counted only once per event.
arm group label: Cytisine 1.5 mg
arm group type: Experimental
description: Multiple doses of 1.5 mg cytisine administered per 25-day schedule:
Days 1-3 (6 times daily)
Days 4-12 (5 times daily)
Days 13-16 (4 times daily)
Days 17-20 (3 times daily)
Days 21-24 (2 times daily)
Day 25 (Once daily)
arm group label: Cytisine 3.0 mg
arm group type: Experimental
description: Multiple doses of 3.0 mg cytisine administered per 25-day schedule:
Days 1-3 (6 times daily)
Days 4-12 (5 times daily)
Days 13-16 (4 times daily)
Days 17-20 (3 times daily)
Days 21-24 (2 times daily)
Day 25 (Once daily)
intervention type: Drug
intervention name: Cytisine
description: film-coated tablets; depending on arm assignment, 1 or 2 tablets to be taken with 240 mL water for each dose
arm group label: Cytisine 1.5 mg
arm group label: Cytisine 3.0 mg
other name: Tabex
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Annelize Koch, MD
role: Principal Investigator
affiliation: Simbec Research Ltd (Simbec)
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 