<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/NCT02998840</url>
  </required_header>
  <id_info>
    <org_study_id>AVB244-003</org_study_id>
    <nct_id>NCT02998840</nct_id>
  </id_info>
  <brief_title>A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure</brief_title>
  <official_title>A Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AOBiome LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Veristat, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AOBiome LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate and compare the efficacy of B244 in treating&#xD;
      patients with hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized Phase II&#xD;
      trial, comparing the effect of twice daily B244 application for 4 weeks vs vehicle&#xD;
      application on BP and inflammatory biomarkers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">June 26, 2017</completion_date>
  <primary_completion_date type="Actual">April 25, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</measure>
    <time_frame>Baseline-6 weeks</time_frame>
    <description>Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups</measure>
    <time_frame>Baseline-Week 4</time_frame>
    <description>Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group</measure>
    <time_frame>Baseline-Week 4</time_frame>
    <description>Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure</measure>
    <time_frame>Baseline-Week 4</time_frame>
    <description>An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Difference in Inflammatory Biomarkers Between Active and Vehicle Groups</measure>
    <time_frame>Baseline-Week 4</time_frame>
    <description>To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers.</description>
  </other_outcome>
  <other_outcome>
    <measure>Microbial Content</measure>
    <time_frame>Baseline, Day 28, Day 42</time_frame>
    <description>Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.</description>
  </other_outcome>
  <other_outcome>
    <measure>Microbial Composition</measure>
    <time_frame>Baseline, Day 28, Day 42</time_frame>
    <description>Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Prehypertension</condition>
  <condition>Hypertension, Stage I</condition>
  <arm_group>
    <arm_group_label>B244 4 pumps applied to the face</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B 244 8 Pumps applied to face and torso</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle 4 pumps applied to the face</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle 8 pumps applied to face and torso</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>B244</intervention_name>
    <description>odorless suspension</description>
    <arm_group_label>B 244 8 Pumps applied to face and torso</arm_group_label>
    <arm_group_label>B244 4 pumps applied to the face</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>odorless suspension</description>
    <arm_group_label>Vehicle 4 pumps applied to the face</arm_group_label>
    <arm_group_label>Vehicle 8 pumps applied to face and torso</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects ≥18 years of age&#xD;
&#xD;
          -  In good general health as determined by a thorough medical history and physical&#xD;
             examination, and vital signs&#xD;
&#xD;
          -  Clinical diagnosis of elevated Blood Pressure defined as:&#xD;
&#xD;
               -  Having systolic prehypertension measurements having systolic BP (mmHg) of 120-139&#xD;
                  and Diastolic BP (mmHg) of 90&#xD;
&#xD;
               -  OR&#xD;
&#xD;
               -  Having systolic Stage 1 hypertension measurements having systolic BP (mmHg) of&#xD;
                  140-159 and Diastolic BP (mmHg) of 100&#xD;
&#xD;
          -  Hypertension treatment naïve patients, defined as those patients who have never been&#xD;
             treated with antihypertensive medications or have been off any hypertensive treatment&#xD;
             for a period of 12 weeks or longer.&#xD;
&#xD;
          -  Willing to refrain from using any antihypertensive treatments, other than the&#xD;
             investigational product, including herbal supplements, systemic use of steroids,&#xD;
             chronic use of NSAIDS, any antihypertensive agents, such as beta-blockers, diuretics,&#xD;
             ACE inhibitors, CA channel blockers, Alpha blockers, Central Acting agents and&#xD;
             vasodilators.&#xD;
&#xD;
          -  Ability to comprehend and comply with procedures&#xD;
&#xD;
          -  Agree to commit to participate in the current protocol&#xD;
&#xD;
          -  Provide written informed consent prior to any study procedure being performed (all&#xD;
             subjects should be able to understand the informed consent form and any other&#xD;
             documents that subjects are required to read)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant and/or lactating women&#xD;
&#xD;
          -  Patients on treatment for Benign Prostatic Hyperplasia (BPH)&#xD;
&#xD;
          -  Clinically significant history of cardiovascular disease (i. e. PCI, CABG MI (if event&#xD;
             occurred 12 months), atrial fibrillation, frequent PAC, cardiac rhythm disorder,&#xD;
             syncope, valve repair/replacement, heart transplantation, PTA, peripheral bypass&#xD;
             surgery, endarterectomy, unstable angina, TIA, stroke and NYHF category II, II and IV&#xD;
             heart failure.&#xD;
&#xD;
          -  Patients with renal failure, significant kidney or renal disease defined as having&#xD;
             creatinine level of mg/dL&#xD;
&#xD;
          -  Presence of any condition (medical, psychological, social, or geographical), actual or&#xD;
             anticipated, that the Investigator feels would restrict or limit the patient's&#xD;
             successful participation for the duration of the study&#xD;
&#xD;
          -  History of migraines and/or anxiety, where patient is unable to refrain from the use&#xD;
             of beta blockers&#xD;
&#xD;
          -  History of sensitivity to any of the study medications, or components thereof or a&#xD;
             history of drug or other allergy that, in the opinion of the Investigator or Medical&#xD;
             Monitor, contraindicates their participation.&#xD;
&#xD;
          -  The participant has been previously randomized in this study&#xD;
&#xD;
          -  Subjects with clinical diagnosis of Type I Diabetes&#xD;
&#xD;
          -  Subjects with arm circumference of 42 cm&#xD;
&#xD;
          -  Any condition that would prevent the subject from participating in the trial in the&#xD;
             opinion of the evaluation physician&#xD;
&#xD;
          -  The participant has received an investigational product within 30 days prior to&#xD;
             randomization&#xD;
&#xD;
          -  Prior use of any product containing B244 or Nitrosomonas eutropha&#xD;
&#xD;
          -  Unable to lie flat or sit for 15 minutes&#xD;
&#xD;
          -  Concurrent participation in other trials&#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>Larry Weiss, MD</last_name>
    <role>Study Director</role>
    <affiliation>Chief Medical Officer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Central Research Associates</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orange County Research Center</name>
      <address>
        <city>Tustin</city>
        <state>California</state>
        <zip>92780</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consulting</name>
      <address>
        <city>Milford</city>
        <state>Connecticut</state>
        <zip>06460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AGA Clinical Trials</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICCT Research International</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedPharmics</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alternative Primary Care (Einstein Clinical Research)</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20190</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHEAR Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Trials WorldWide</name>
      <address>
        <city>Humble</city>
        <state>Texas</state>
        <zip>77338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>July 19, 2022</results_first_submitted>
  <results_first_submitted_qc>July 19, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 15, 2022</results_first_posted>
  <disposition_first_submitted>July 28, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>July 28, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 30, 2020</disposition_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>elevated blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Prehypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT02998840/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>June 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT02998840/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>B244 4 Pumps Applied to the Face</title>
          <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
        </group>
        <group group_id="P2">
          <title>B 244 8 Pumps Applied to Face and Torso</title>
          <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
        </group>
        <group group_id="P3">
          <title>Vehicle 4 Pumps Applied to the Face</title>
          <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
        </group>
        <group group_id="P4">
          <title>Vehicle 8 Pumps Applied to Face and Torso</title>
          <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unplanned travel, family emergency, sponsor request, work schedule</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat Population (ITT): All randomized subjects, analyzed according to treatment assigned.</population>
      <group_list>
        <group group_id="B1">
          <title>B244 4 Pumps Applied to the Face</title>
          <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
        </group>
        <group group_id="B2">
          <title>B 244 8 Pumps Applied to Face and Torso</title>
          <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
        </group>
        <group group_id="B3">
          <title>Vehicle 4 Pumps Applied to the Face</title>
          <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
        </group>
        <group group_id="B4">
          <title>Vehicle 8 Pumps Applied to Face and Torso</title>
          <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="33"/>
            <count group_id="B4" value="33"/>
            <count group_id="B5" value="132"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;60 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="27"/>
                    <measurement group_id="B5" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥60 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="32"/>
                  </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="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="70"/>
                  </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="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="94"/>
                  </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89.32" spread="21.084"/>
                    <measurement group_id="B2" value="89.04" spread="21.654"/>
                    <measurement group_id="B3" value="86.56" spread="12.251"/>
                    <measurement group_id="B4" value="88.59" spread="18.871"/>
                    <measurement group_id="B5" value="88.38" spread="18.654"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.139" spread="6.2438"/>
                    <measurement group_id="B2" value="30.427" spread="5.9047"/>
                    <measurement group_id="B3" value="29.306" spread="4.3707"/>
                    <measurement group_id="B4" value="30.304" spread="6.3886"/>
                    <measurement group_id="B5" value="30.044" spread="5.7332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI Category</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;30 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>≥30 kg/m^2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Former</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</title>
        <description>Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.</description>
        <time_frame>Baseline-6 weeks</time_frame>
        <population>Safety Population: All subjects who received at least 1 dose of study medication. Subjects were to be analyzed according to the study drug received.</population>
        <group_list>
          <group group_id="O1">
            <title>B244 4 Pumps Applied to the Face</title>
            <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O2">
            <title>B 244 8 Pumps Applied to Face and Torso</title>
            <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O3">
            <title>Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)</title>
            <description>4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0</title>
          <description>Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.</description>
          <population>Safety Population: All subjects who received at least 1 dose of study medication. Subjects were to be analyzed according to the study drug received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At Least 1 Treatment Related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At Least 1 Treatment Related Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups</title>
        <description>Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.</description>
        <time_frame>Baseline-Week 4</time_frame>
        <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects, analyzed according to treatment assigned) that remained in the study at Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>B244 4 Pumps Applied to the Face</title>
            <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O2">
            <title>B 244 8 Pumps Applied to Face and Torso</title>
            <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O3">
            <title>Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)</title>
            <description>4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups</title>
          <description>Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.</description>
          <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects, analyzed according to treatment assigned) that remained in the study at Week 4.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.61" spread="1.828"/>
                    <measurement group_id="O2" value="-0.66" spread="1.834"/>
                    <measurement group_id="O3" value="-2.93" spread="1.296"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group</title>
        <description>Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.</description>
        <time_frame>Baseline-Week 4</time_frame>
        <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects, analyzed according to treatment assigned) that remained in the study at Week 4.</population>
        <group_list>
          <group group_id="O1">
            <title>B244 4 Pumps Applied to the Face</title>
            <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O2">
            <title>B 244 8 Pumps Applied to Face and Torso</title>
            <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O3">
            <title>Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)</title>
            <description>4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group</title>
          <description>Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.</description>
          <population>Subjects from the Intent to Treat (ITT) population (all randomized subjects, analyzed according to treatment assigned) that remained in the study at Week 4.</population>
          <units>mmHg</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.65" spread="1.377"/>
                    <measurement group_id="O2" value="-2.25" spread="1.358"/>
                    <measurement group_id="O3" value="-1.31" spread="0.975"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure</title>
        <description>An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements.</description>
        <time_frame>Baseline-Week 4</time_frame>
        <population>Ambulatory Blood Pressure Monitoring Population (ABPP): Subjects in the Safety Population who had valid baseline and Day 28 ambulatory BP monitoring (ABPM) measurements. Subjects who repeated the ABPM were to be included in the population if the repeated assessment met the device monitor's criteria for &quot;passing&quot;.</population>
        <group_list>
          <group group_id="O1">
            <title>B244 4 Pumps Applied to the Face</title>
            <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O2">
            <title>B 244 8 Pumps Applied to Face and Torso</title>
            <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O3">
            <title>Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)</title>
            <description>4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure</title>
          <description>An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements.</description>
          <population>Ambulatory Blood Pressure Monitoring Population (ABPP): Subjects in the Safety Population who had valid baseline and Day 28 ambulatory BP monitoring (ABPM) measurements. Subjects who repeated the ABPM were to be included in the population if the repeated assessment met the device monitor's criteria for &quot;passing&quot;.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.06" spread="9.388"/>
                    <measurement group_id="O2" value="-0.21" spread="12.250"/>
                    <measurement group_id="O3" value="-0.53" spread="7.619"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.17" spread="5.327"/>
                    <measurement group_id="O2" value="-0.82" spread="7.325"/>
                    <measurement group_id="O3" value="-0.98" spread="5.911"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Difference in Inflammatory Biomarkers Between Active and Vehicle Groups</title>
        <description>To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers.</description>
        <time_frame>Baseline-Week 4</time_frame>
        <population>Intent to Treat Population (ITT): All randomized subjects, analyzed according to treatment assigned.</population>
        <group_list>
          <group group_id="O1">
            <title>B244 4 Pumps Applied to the Face</title>
            <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O2">
            <title>B 244 8 Pumps Applied to Face and Torso</title>
            <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O3">
            <title>Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)</title>
            <description>4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Inflammatory Biomarkers Between Active and Vehicle Groups</title>
          <description>To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers.</description>
          <population>Intent to Treat Population (ITT): All randomized subjects, analyzed according to treatment assigned.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">NA Explanation: Data not collected/completed for exploratory endpoint.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">NA Explanation: Data not collected/completed for exploratory endpoint.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">NA Explanation: Data not collected/completed for exploratory endpoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Microbial Content</title>
        <description>Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.</description>
        <time_frame>Baseline, Day 28, Day 42</time_frame>
        <population>Data was not collected for this exploratory endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>B244 4 Pumps Applied to the Face</title>
            <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O2">
            <title>B 244 8 Pumps Applied to Face and Torso</title>
            <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O3">
            <title>Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)</title>
            <description>4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Microbial Content</title>
          <description>Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.</description>
          <population>Data was not collected for this exploratory endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Microbial Composition</title>
        <description>Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples.</description>
        <time_frame>Baseline, Day 28, Day 42</time_frame>
        <population>Data was not collected for this exploratory endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>B244 4 Pumps Applied to the Face</title>
            <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O2">
            <title>B 244 8 Pumps Applied to Face and Torso</title>
            <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
          </group>
          <group group_id="O3">
            <title>Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)</title>
            <description>4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Microbial Composition</title>
          <description>Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples.</description>
          <population>Data was not collected for this exploratory endpoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline-Week 6</time_frame>
      <desc>Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.</desc>
      <group_list>
        <group group_id="E1">
          <title>B244 4 Pumps Applied to the Face</title>
          <description>4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
        </group>
        <group group_id="E2">
          <title>B 244 8 Pumps Applied to Face and Torso</title>
          <description>8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.&#xD;
B244: odorless suspension, 8x10E9 cells/mL</description>
        </group>
        <group group_id="E3">
          <title>Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)</title>
          <description>4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.&#xD;
Vehicle: odorless suspension</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Exacerbation of depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="4" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </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="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="66"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="66"/>
              </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>Sponsor shall have 45 days to review the papers. Sponsor shall have the right to require Institution/Principal Investigator, as applicable, to remove specifically identified confidential information and/or delay the proposed publication or presentation for an additional one hundred twenty (120) days to enable Sponsor to seek patent protections.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Hyun Kim, Vice President Clinical Operations</name_or_title>
      <organization>AOBiome Therapeutics</organization>
      <phone>617-639-9980</phone>
      <email>hkim@aobiome.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/NCT02998840
org study id: AVB244-003
nct id: NCT02998840
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to evaluate and compare the efficacy of B244 in treating
      patients with hypertension.
This is a Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized Phase II
      trial, comparing the effect of twice daily B244 application for 4 weeks vs vehicle
      application on BP and inflammatory biomarkers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
time frame: Baseline-6 weeks
description: Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
measure: Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups
time frame: Baseline-Week 4
description: Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
measure: Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
time frame: Baseline-Week 4
description: Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
measure: Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
time frame: Baseline-Week 4
description: An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements.
measure: Difference in Inflammatory Biomarkers Between Active and Vehicle Groups
time frame: Baseline-Week 4
description: To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers.
measure: Microbial Content
time frame: Baseline, Day 28, Day 42
description: Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
measure: Microbial Composition
time frame: Baseline, Day 28, Day 42
description: Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples.
arm group label: B244 4 pumps applied to the face
arm group type: Active Comparator
description: 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
arm group label: B 244 8 Pumps applied to face and torso
arm group type: Active Comparator
description: 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
arm group label: Vehicle 4 pumps applied to the face
arm group type: Sham Comparator
description: 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
arm group label: Vehicle 8 pumps applied to face and torso
arm group type: Sham Comparator
description: 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
intervention type: Biological
intervention name: B244
description: odorless suspension
arm group label: B 244 8 Pumps applied to face and torso
arm group label: B244 4 pumps applied to the face
intervention type: Biological
intervention name: Vehicle
description: odorless suspension
arm group label: Vehicle 4 pumps applied to the face
arm group label: Vehicle 8 pumps applied to face and torso
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Larry Weiss, MD
role: Study Director
affiliation: Chief Medical Officer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Prehypertension
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 