<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/NCT04429932</url>
  </required_header>
  <id_info>
    <org_study_id>CA22736</org_study_id>
    <nct_id>NCT04429932</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes</brief_title>
  <official_title>An Open-Label, Randomized, Crossover Study to Assess Nicotine Uptake, Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fontem US LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fontem Ventures BV</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fontem Ventures BV</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette&#xD;
      device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and&#xD;
      consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study&#xD;
      in adult smokers.&#xD;
&#xD;
      Subjects are invited to participate to a second part of the study, for 5 additional days, to&#xD;
      compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Nicotine Concentration in Blood</measure>
    <time_frame>180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)</time_frame>
    <description>Maximum nicotine concentration in blood (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Carboxyhemoglobin in Blood</measure>
    <time_frame>Baseline and 8 days</time_frame>
    <description>Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours</measure>
    <time_frame>Baseline and 8 days</time_frame>
    <description>Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours</measure>
    <time_frame>Baseline and 8 days</time_frame>
    <description>Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours</measure>
    <time_frame>Baseline and 8 days</time_frame>
    <description>Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Level of White Blood Cells</measure>
    <time_frame>Baseline and 8 days</time_frame>
    <description>The change from baseline in the level of white blood cells, a biomarker of potential harm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry: Forced Expiratory Volume in 1 Second</measure>
    <time_frame>Baseline and 8 days</time_frame>
    <description>The percent-predicted forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry: Forced Vital Capacity</measure>
    <time_frame>Baseline and 8 days</time_frame>
    <description>The percent-predicted forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Measure: Urge to Smoke</measure>
    <time_frame>8 days</time_frame>
    <description>Urge to smoke score: Subjects answer the following question &quot;How strong is your urge to smoke right now?&quot; using a visual analogue scale. The scale ranges from &quot;Not at all&quot;, given a score of 0, to &quot;Extremely&quot;, given a score of 100, after ad libitum use of the product.</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Product use sequence ABDC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Product use sequence BCAD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Same as previous arm, but in a different randomization order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Product use sequence CDBA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Same as previous arm, but in a different randomization order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Product use sequence DACB</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Same as previous arm, but in a different randomization order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Product use sequence EFHG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Product use sequence FGEH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Same as previous arm, but in a different randomization order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Product use sequence GHFE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Same as previous arm, but in a different randomization order.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Product use sequence HEGF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Same as previous arm, but in a different randomization order.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myblu flavor A_2.4</intervention_name>
    <description>Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine</description>
    <arm_group_label>Product use sequence ABDC</arm_group_label>
    <arm_group_label>Product use sequence BCAD</arm_group_label>
    <arm_group_label>Product use sequence CDBA</arm_group_label>
    <arm_group_label>Product use sequence DACB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myblu flavor B_2.4</intervention_name>
    <description>Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine</description>
    <arm_group_label>Product use sequence ABDC</arm_group_label>
    <arm_group_label>Product use sequence BCAD</arm_group_label>
    <arm_group_label>Product use sequence DACB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myblu flavor C_2.4</intervention_name>
    <description>Use of Myblu e-cigarette with flavor C at 2.4% nicotine</description>
    <arm_group_label>Product use sequence ABDC</arm_group_label>
    <arm_group_label>Product use sequence BCAD</arm_group_label>
    <arm_group_label>Product use sequence CDBA</arm_group_label>
    <arm_group_label>Product use sequence DACB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myblu flavor D_2.4</intervention_name>
    <description>Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
    <arm_group_label>Product use sequence ABDC</arm_group_label>
    <arm_group_label>Product use sequence BCAD</arm_group_label>
    <arm_group_label>Product use sequence CDBA</arm_group_label>
    <arm_group_label>Product use sequence DACB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myblu flavor E_1.2</intervention_name>
    <description>Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine</description>
    <arm_group_label>Product use sequence EFHG</arm_group_label>
    <arm_group_label>Product use sequence FGEH</arm_group_label>
    <arm_group_label>Product use sequence GHFE</arm_group_label>
    <arm_group_label>Product use sequence HEGF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myblu flavor F_1.2</intervention_name>
    <description>Fse of Myblu e-cigarette with flavor F at 1.2% nicotine</description>
    <arm_group_label>Product use sequence EFHG</arm_group_label>
    <arm_group_label>Product use sequence FGEH</arm_group_label>
    <arm_group_label>Product use sequence GHFE</arm_group_label>
    <arm_group_label>Product use sequence HEGF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myblu flavor G_2.4</intervention_name>
    <description>Use of Myblu e-cigarette with flavor G at 2.4% nicotine</description>
    <arm_group_label>Product use sequence EFHG</arm_group_label>
    <arm_group_label>Product use sequence FGEH</arm_group_label>
    <arm_group_label>Product use sequence GHFE</arm_group_label>
    <arm_group_label>Product use sequence HEGF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Myblu flavor H_2.4</intervention_name>
    <description>Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
    <arm_group_label>Product use sequence EFHG</arm_group_label>
    <arm_group_label>Product use sequence FGEH</arm_group_label>
    <arm_group_label>Product use sequence GHFE</arm_group_label>
    <arm_group_label>Product use sequence HEGF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  smoking an average of at least 10 manufactured combustible cigarettes per day for at&#xD;
             least 12 months prior to Screening&#xD;
&#xD;
          -  tested positive for urine cotinine (≥ 200 ng/mL) at Screening&#xD;
&#xD;
          -  exhaled carbon monoxide &gt; 10 ppm (parts per million) at Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  relevant illness history&#xD;
&#xD;
          -  relevant medication use&#xD;
&#xD;
          -  body mass index (BMI) &gt; 40 kg/m2 or &lt; 18 kg/m2 at Screening&#xD;
&#xD;
          -  allergy to propylene glycol or glycerin&#xD;
&#xD;
          -  use of nicotine-containing products other than manufactured combustible cigarettes&#xD;
             within 14 days prior to Check-in&#xD;
&#xD;
          -  use of any prescription smoking cessation treatments within 3 months prior to Check-in&#xD;
&#xD;
          -  smokers who draw smoke from the cigarette into the mouth and throat but do not inhale&#xD;
&#xD;
          -  planning to quit smoking during the study&#xD;
&#xD;
          -  female subjects who are pregnant, lactating, or intend to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <results_first_submitted>April 14, 2021</results_first_submitted>
  <results_first_submitted_qc>May 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 7, 2021</results_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>December 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT04429932/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>February 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT04429932/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Product Use Sequence ABDC</title>
          <description>Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).&#xD;
Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine&#xD;
Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine&#xD;
Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine&#xD;
Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
        </group>
        <group group_id="P2">
          <title>Product Use Sequence BCAD</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine&#xD;
Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine&#xD;
Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine&#xD;
Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
        </group>
        <group group_id="P3">
          <title>Product Use Sequence CDBA</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine&#xD;
Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine&#xD;
Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
        </group>
        <group group_id="P4">
          <title>Product Use Sequence DACB</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine&#xD;
Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine&#xD;
Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine&#xD;
Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
        </group>
        <group group_id="P5">
          <title>Product Use Sequence EFHG</title>
          <description>Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).&#xD;
Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine&#xD;
Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine&#xD;
Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine&#xD;
Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
        </group>
        <group group_id="P6">
          <title>Product Use Sequence FGEH</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine&#xD;
Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine&#xD;
Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine&#xD;
Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
        </group>
        <group group_id="P7">
          <title>Product Use Sequence GHFE</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine&#xD;
Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine&#xD;
Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine&#xD;
Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
        </group>
        <group group_id="P8">
          <title>Product Use Sequence HEGF</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine&#xD;
Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine&#xD;
Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine&#xD;
Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="5"/>
                <participants group_id="P8" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Product Use Sequence ABDC</title>
          <description>Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).&#xD;
Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine&#xD;
Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine&#xD;
Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine&#xD;
Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
        </group>
        <group group_id="B2">
          <title>Product Use Sequence BCAD</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine&#xD;
Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine&#xD;
Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine&#xD;
Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
        </group>
        <group group_id="B3">
          <title>Product Use Sequence CDBA</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine&#xD;
Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine&#xD;
Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
        </group>
        <group group_id="B4">
          <title>Product Use Sequence DACB</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor A_2.4: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine&#xD;
Myblu flavor B_2.4: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine&#xD;
Myblu flavor C_2.4: Use of Myblu e-cigarette with flavor C at 2.4% nicotine&#xD;
Myblu flavor D_2.4: Use of Myblu e-cigarette with flavor D at 2.4% nicotine</description>
        </group>
        <group group_id="B5">
          <title>Product Use Sequence EFHG</title>
          <description>Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).&#xD;
Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine&#xD;
Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine&#xD;
Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine&#xD;
Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
        </group>
        <group group_id="B6">
          <title>Product Use Sequence FGEH</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine&#xD;
Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine&#xD;
Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine&#xD;
Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
        </group>
        <group group_id="B7">
          <title>Product Use Sequence GHFE</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine&#xD;
Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine&#xD;
Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine&#xD;
Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
        </group>
        <group group_id="B8">
          <title>Product Use Sequence HEGF</title>
          <description>Same as previous arm, but in a different randomization order.&#xD;
Myblu flavor E_1.2: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine&#xD;
Myblu flavor F_1.2: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine&#xD;
Myblu flavor G_2.4: Use of Myblu e-cigarette with flavor G at 2.4% nicotine&#xD;
Myblu flavor H_2.4: Use of Myblu e-cigarette with flavor H at 2.4% nicotine</description>
        </group>
        <group group_id="B9">
          <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="4"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="5"/>
            <count group_id="B5" value="5"/>
            <count group_id="B6" value="5"/>
            <count group_id="B7" value="5"/>
            <count group_id="B8" value="5"/>
            <count group_id="B9" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.3" spread="15.8"/>
                    <measurement group_id="B2" value="49.0" spread="4.9"/>
                    <measurement group_id="B3" value="38.0" spread="9.2"/>
                    <measurement group_id="B4" value="32.6" spread="7.2"/>
                    <measurement group_id="B5" value="36.4" spread="7.0"/>
                    <measurement group_id="B6" value="40.8" spread="8.7"/>
                    <measurement group_id="B7" value="46.4" spread="10.0"/>
                    <measurement group_id="B8" value="50.0" spread="6.4"/>
                    <measurement group_id="B9" value="41.8" spread="10.0"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.8" spread="4.2"/>
                    <measurement group_id="B2" value="30.5" spread="5.5"/>
                    <measurement group_id="B3" value="28.2" spread="5.0"/>
                    <measurement group_id="B4" value="26.1" spread="4.1"/>
                    <measurement group_id="B5" value="29.4" spread="4.4"/>
                    <measurement group_id="B6" value="29.7" spread="7.7"/>
                    <measurement group_id="B7" value="28.5" spread="4.2"/>
                    <measurement group_id="B8" value="28.7" spread="6.3"/>
                    <measurement group_id="B9" value="28.4" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Nicotine Concentration in Blood</title>
        <description>Maximum nicotine concentration in blood (Cmax)</description>
        <time_frame>180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Product Variant A</title>
            <description>MyBlu e-cigarette variant A (2.4% nicotine)</description>
          </group>
          <group group_id="O2">
            <title>Product Variant B</title>
            <description>MyBlu e- igarette variant B (2.4% nicotine)</description>
          </group>
          <group group_id="O3">
            <title>Product Variant C</title>
            <description>MyBlu e-cigarette variant C (2.4% nicotine)</description>
          </group>
          <group group_id="O4">
            <title>Product Variant D</title>
            <description>MyBlu e-cigarette variant D (2.4% nicotine)</description>
          </group>
          <group group_id="O5">
            <title>Product Variant E</title>
            <description>MyBlu e- cigarette variant E (1.2% nicotine)</description>
          </group>
          <group group_id="O6">
            <title>Product Variant F</title>
            <description>MyBlu e-cigarette variant F (1.2% nicotine)</description>
          </group>
          <group group_id="O7">
            <title>Product Variant G</title>
            <description>MyBlu e-cigarette variant G (2.4% nicotine)</description>
          </group>
          <group group_id="O8">
            <title>Product Variant H</title>
            <description>MyBlu e-cigarette variant H (2.4% nicotine)</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Nicotine Concentration in Blood</title>
          <description>Maximum nicotine concentration in blood (Cmax)</description>
          <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="14"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="137.5"/>
                    <measurement group_id="O2" value="7.9" spread="91.8"/>
                    <measurement group_id="O3" value="5.6" spread="107.2"/>
                    <measurement group_id="O4" value="6.0" spread="184.5"/>
                    <measurement group_id="O5" value="2.6" spread="88.7"/>
                    <measurement group_id="O6" value="2.7" spread="91.4"/>
                    <measurement group_id="O7" value="4.4" spread="94.4"/>
                    <measurement group_id="O8" value="3.5" spread="295.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Concentration of Carboxyhemoglobin in Blood</title>
        <description>Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.</description>
        <time_frame>Baseline and 8 days</time_frame>
        <population>Data is missing for 3 participants at the 8 days timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>Exclusive MyBlu E-cigarette Use</title>
            <description>Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Carboxyhemoglobin in Blood</title>
          <description>Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.</description>
          <population>Data is missing for 3 participants at the 8 days timepoint</population>
          <units>% saturation</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline value</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours</title>
        <description>Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).</description>
        <time_frame>Baseline and 8 days</time_frame>
        <population>Data is missing for 3 participants at the 8 days timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>Exclusive MyBlu E-cigarette Use</title>
            <description>Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours</title>
          <description>Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).</description>
          <population>Data is missing for 3 participants at the 8 days timepoint</population>
          <units>ng/g creatinine</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="176.2" spread="87.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-134.8" spread="66.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours</title>
        <description>Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).</description>
        <time_frame>Baseline and 8 days</time_frame>
        <population>Data is missing for 3 participants at the 8 days timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>Exclusive MyBlu E-cigarette Use</title>
            <description>Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours</title>
          <description>Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).</description>
          <population>Data is missing for 3 participants at the 8 days timepoint</population>
          <units>ug/g creatinine</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline value</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="756.2" spread="279.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-599.3" spread="276.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours</title>
        <description>Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).</description>
        <time_frame>Baseline and 8 days</time_frame>
        <population>Data is missing for 3 participants at the 8 days timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>Exclusive MyBlu E-cigarette Use</title>
            <description>Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours</title>
          <description>Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).</description>
          <population>Data is missing for 3 participants at the 8 days timepoint</population>
          <units>ug/g creatinine</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline value</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.5" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Level of White Blood Cells</title>
        <description>The change from baseline in the level of white blood cells, a biomarker of potential harm.</description>
        <time_frame>Baseline and 8 days</time_frame>
        <population>Data is missing for 3 participants at the 8 days timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>Exclusive MyBlu E-cigarette Use</title>
            <description>Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)</description>
          </group>
        </group_list>
        <measure>
          <title>Level of White Blood Cells</title>
          <description>The change from baseline in the level of white blood cells, a biomarker of potential harm.</description>
          <population>Data is missing for 3 participants at the 8 days timepoint</population>
          <units>cells*10^9/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline value</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spirometry: Forced Expiratory Volume in 1 Second</title>
        <description>The percent-predicted forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.</description>
        <time_frame>Baseline and 8 days</time_frame>
        <population>Data is missing for 3 participants at the 8 days timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>Exclusive MyBlu E-cigarette Use</title>
            <description>Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)</description>
          </group>
        </group_list>
        <measure>
          <title>Spirometry: Forced Expiratory Volume in 1 Second</title>
          <description>The percent-predicted forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.</description>
          <population>Data is missing for 3 participants at the 8 days timepoint</population>
          <units>Percent-predicted FEV1</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 days timepoint</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spirometry: Forced Vital Capacity</title>
        <description>The percent-predicted forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.</description>
        <time_frame>Baseline and 8 days</time_frame>
        <population>Data is missing for 3 participants at the 8 days timepoint</population>
        <group_list>
          <group group_id="O1">
            <title>Exclusive MyBlu E-cigarette Use</title>
            <description>Subjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)</description>
          </group>
        </group_list>
        <measure>
          <title>Spirometry: Forced Vital Capacity</title>
          <description>The percent-predicted forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.</description>
          <population>Data is missing for 3 participants at the 8 days timepoint</population>
          <units>Percent-predicted FVC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline value</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.0" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8 days timepoint</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.3" spread="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Measure: Urge to Smoke</title>
        <description>Urge to smoke score: Subjects answer the following question &quot;How strong is your urge to smoke right now?&quot; using a visual analogue scale. The scale ranges from &quot;Not at all&quot;, given a score of 0, to &quot;Extremely&quot;, given a score of 100, after ad libitum use of the product.</description>
        <time_frame>8 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Product Variant A</title>
            <description>MyBlu e-cigarette variant A (2.4% nicotine)</description>
          </group>
          <group group_id="O2">
            <title>Product Variant B</title>
            <description>MyBlu e- igarette variant B (2.4% nicotine)</description>
          </group>
          <group group_id="O3">
            <title>Product Variant C</title>
            <description>MyBlu e-cigarette variant C (2.4% nicotine)</description>
          </group>
          <group group_id="O4">
            <title>Product Variant D</title>
            <description>MyBlu e-cigarette variant D (2.4% nicotine)</description>
          </group>
          <group group_id="O5">
            <title>Product Variant E</title>
            <description>MyBlu e- cigarette variant E (1.2% nicotine)</description>
          </group>
          <group group_id="O6">
            <title>Product Variant F</title>
            <description>MyBlu e-cigarette variant F (1.2% nicotine)</description>
          </group>
          <group group_id="O7">
            <title>Product Variant G</title>
            <description>MyBlu e-cigarette variant G (2.4% nicotine)</description>
          </group>
          <group group_id="O8">
            <title>Product Variant H</title>
            <description>MyBlu e-cigarette variant H (2.4% nicotine)</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Measure: Urge to Smoke</title>
          <description>Urge to smoke score: Subjects answer the following question &quot;How strong is your urge to smoke right now?&quot; using a visual analogue scale. The scale ranges from &quot;Not at all&quot;, given a score of 0, to &quot;Extremely&quot;, given a score of 100, after ad libitum use of the product.</description>
          <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="16"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="20"/>
                <count group_id="O7" value="20"/>
                <count group_id="O8" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.3" spread="21.9"/>
                    <measurement group_id="O2" value="76.4" spread="13.8"/>
                    <measurement group_id="O3" value="64.9" spread="23.4"/>
                    <measurement group_id="O4" value="67.6" spread="26.0"/>
                    <measurement group_id="O5" value="53.7" spread="32.6"/>
                    <measurement group_id="O6" value="54.4" spread="29.5"/>
                    <measurement group_id="O7" value="55.4" spread="29.9"/>
                    <measurement group_id="O8" value="59.0" spread="31.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Product Variant A</title>
          <description>MyBlu e-cigarette variant A (2.4% nicotine)</description>
        </group>
        <group group_id="E2">
          <title>Product Variant B</title>
          <description>MyBlu e- igarette variant B (2.4% nicotine)</description>
        </group>
        <group group_id="E3">
          <title>Product Variant C</title>
          <description>MyBlu e-cigarette variant C (2.4% nicotine)</description>
        </group>
        <group group_id="E4">
          <title>Product Variant D</title>
          <description>MyBlu e-cigarette variant D (2.4% nicotine)</description>
        </group>
        <group group_id="E5">
          <title>Product Variant E</title>
          <description>MyBlu e- cigarette variant E (1.2% nicotine)</description>
        </group>
        <group group_id="E6">
          <title>Product Variant F</title>
          <description>MyBlu e-cigarette variant F (1.2% nicotine)</description>
        </group>
        <group group_id="E7">
          <title>Product Variant G</title>
          <description>MyBlu e-cigarette variant G (2.4% nicotine)</description>
        </group>
        <group group_id="E8">
          <title>Product Variant H</title>
          <description>MyBlu e-cigarette variant H (2.4% nicotine)</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="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA® Version 22.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Hypoesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Contact dermitits</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Paul Morris</name_or_title>
      <organization>Nerudia Ltd</organization>
      <phone>+44 7508 708 917</phone>
      <email>paul.morris@nerudia.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/NCT04429932
org study id: CA22736
nct id: NCT04429932
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette
      device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and
      consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study
      in adult smokers.

      Subjects are invited to participate to a second part of the study, for 5 additional days, to
      compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Nicotine Concentration in Blood
time frame: 180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)
description: Maximum nicotine concentration in blood (Cmax)
measure: Concentration of Carboxyhemoglobin in Blood
time frame: Baseline and 8 days
description: Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.
measure: Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
time frame: Baseline and 8 days
description: Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).
measure: Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
time frame: Baseline and 8 days
description: Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).
measure: Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours
time frame: Baseline and 8 days
description: Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).
measure: Level of White Blood Cells
time frame: Baseline and 8 days
description: The change from baseline in the level of white blood cells, a biomarker of potential harm.
measure: Spirometry: Forced Expiratory Volume in 1 Second
time frame: Baseline and 8 days
description: The percent-predicted forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.
measure: Spirometry: Forced Vital Capacity
time frame: Baseline and 8 days
description: The percent-predicted forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.
measure: Subjective Measure: Urge to Smoke
time frame: 8 days
description: Urge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale. The scale ranges from "Not at all", given a score of 0, to "Extremely", given a score of 100, after ad libitum use of the product.
arm group label: Product use sequence ABDC
arm group type: Experimental
description: Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
arm group label: Product use sequence BCAD
arm group type: Experimental
description: Same as previous arm, but in a different randomization order.
arm group label: Product use sequence CDBA
arm group type: Experimental
description: Same as previous arm, but in a different randomization order.
arm group label: Product use sequence DACB
arm group type: Experimental
description: Same as previous arm, but in a different randomization order.
arm group label: Product use sequence EFHG
arm group type: Experimental
description: Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
arm group label: Product use sequence FGEH
arm group type: Experimental
description: Same as previous arm, but in a different randomization order.
arm group label: Product use sequence GHFE
arm group type: Experimental
description: Same as previous arm, but in a different randomization order.
arm group label: Product use sequence HEGF
arm group type: Experimental
description: Same as previous arm, but in a different randomization order.
intervention type: Other
intervention name: Myblu flavor A_2.4
description: Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine
arm group label: Product use sequence ABDC
arm group label: Product use sequence BCAD
arm group label: Product use sequence CDBA
arm group label: Product use sequence DACB
intervention type: Other
intervention name: Myblu flavor B_2.4
description: Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine
arm group label: Product use sequence ABDC
arm group label: Product use sequence BCAD
arm group label: Product use sequence DACB
intervention type: Other
intervention name: Myblu flavor C_2.4
description: Use of Myblu e-cigarette with flavor C at 2.4% nicotine
arm group label: Product use sequence ABDC
arm group label: Product use sequence BCAD
arm group label: Product use sequence CDBA
arm group label: Product use sequence DACB
intervention type: Other
intervention name: Myblu flavor D_2.4
description: Use of Myblu e-cigarette with flavor D at 2.4% nicotine
arm group label: Product use sequence ABDC
arm group label: Product use sequence BCAD
arm group label: Product use sequence CDBA
arm group label: Product use sequence DACB
intervention type: Other
intervention name: Myblu flavor E_1.2
description: Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine
arm group label: Product use sequence EFHG
arm group label: Product use sequence FGEH
arm group label: Product use sequence GHFE
arm group label: Product use sequence HEGF
intervention type: Other
intervention name: Myblu flavor F_1.2
description: Fse of Myblu e-cigarette with flavor F at 1.2% nicotine
arm group label: Product use sequence EFHG
arm group label: Product use sequence FGEH
arm group label: Product use sequence GHFE
arm group label: Product use sequence HEGF
intervention type: Other
intervention name: Myblu flavor G_2.4
description: Use of Myblu e-cigarette with flavor G at 2.4% nicotine
arm group label: Product use sequence EFHG
arm group label: Product use sequence FGEH
arm group label: Product use sequence GHFE
arm group label: Product use sequence HEGF
intervention type: Other
intervention name: Myblu flavor H_2.4
description: Use of Myblu e-cigarette with flavor H at 2.4% nicotine
arm group label: Product use sequence EFHG
arm group label: Product use sequence FGEH
arm group label: Product use sequence GHFE
arm group label: Product use sequence HEGF
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 