<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/NCT03795922</url>
  </required_header>
  <id_info>
    <org_study_id>MT10109L-001</org_study_id>
    <secondary_id>2018-004384-31</secondary_id>
    <nct_id>NCT03795922</nct_id>
  </id_info>
  <brief_title>MT10109L in the Treatment of Glabellar Lines</brief_title>
  <official_title>A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medy-Tox</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medy-Tox</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in&#xD;
      participants with moderate to severe GL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 24, 2018</start_date>
  <completion_date type="Actual">January 25, 2021</completion_date>
  <primary_completion_date type="Actual">March 13, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30</measure>
    <time_frame>Day 30</time_frame>
    <description>The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe.&#xD;
The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)</measure>
    <time_frame>Day 30</time_frame>
    <description>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS)</measure>
    <time_frame>Day 1 (first treatment) to Day 180</time_frame>
    <description>The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL)</measure>
    <time_frame>Day 60</time_frame>
    <description>The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).</measure>
    <time_frame>Day 30</time_frame>
    <description>The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration</measure>
    <time_frame>The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).</time_frame>
    <description>This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)</measure>
    <time_frame>Baseline to Study exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)</measure>
    <time_frame>Baseline to Study exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Vital Signs - Pulse Rate</measure>
    <time_frame>Baseline to Study exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Vital Signs - Respiratory Rate</measure>
    <time_frame>Baseline to Study exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate</measure>
    <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval</measure>
    <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration</measure>
    <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval</measure>
    <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval</measure>
    <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval</measure>
    <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval</measure>
    <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
    <description>Change from baseline at study exit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Binding and Neutralizing Antibodies</measure>
    <time_frame>Up to Study Exit (Day 360 or early exit)</time_frame>
    <description>Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">234</enrollment>
  <condition>Glabellar Lines</condition>
  <arm_group>
    <arm_group_label>MT10109L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be injected into the GL: initial double-blind treatment on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MT10109L</intervention_name>
    <description>MT10109L will be injected into the GL.</description>
    <arm_group_label>MT10109L</arm_group_label>
    <other_name>NivobotulinumtoxinA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo will be injected into the GL.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        • Female participants must not be pregnant or planning to get pregnant and willing to&#xD;
        minimize the risk of inducing pregnancy for the duration of the clinical study and&#xD;
        follow-up period.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Known immunization or hypersensitivity to any botulinum toxin serotype.&#xD;
&#xD;
          -  Any medical condition that may put the participant at increased risk with exposure to&#xD;
             MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic&#xD;
             lateral sclerosis, or any other condition that might interfere with neuromuscular&#xD;
             function.&#xD;
&#xD;
          -  History of facial nerve palsy.&#xD;
&#xD;
          -  Any uncontrolled systemic disease.&#xD;
&#xD;
          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason&#xD;
             during the study (other than study intervention).&#xD;
&#xD;
          -  Anticipated need for surgery or overnight hospitalization during the study.&#xD;
&#xD;
          -  Prior exposure to botulinum toxin of any serotype for any reason.&#xD;
&#xD;
          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow&#xD;
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).&#xD;
&#xD;
          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,&#xD;
             Gore-Tex®), and/or autologous fat transplantation.&#xD;
&#xD;
          -  Current enrollment in an investigational drug or device study or participation in such&#xD;
             a study within 30 days of entry into this study.&#xD;
&#xD;
          -  Females who are pregnant, nursing, or planning a pregnancy during the study.&#xD;
&#xD;
          -  Participants who plan for an extended absence away from the immediate area of the&#xD;
             study site that would preclude them from returning for all protocol-specified study&#xD;
             visits.&#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>SangMi Park</last_name>
    <role>Study Director</role>
    <affiliation>Medytox Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigate MD</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Art of Skin MD</name>
      <address>
        <city>Solana Beach</city>
        <state>California</state>
        <zip>92075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weinkle Dermatology</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Etre, Cosmetic Dermatology and Laser Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology and Laser Surgery Center of New York</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SkinSearch of Rochester, Inc.</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M3 Wake Research, Inc.</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research, Inc.</name>
      <address>
        <city>Dublin</city>
        <state>Ohio</state>
        <zip>43016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westlake Dermatology &amp; Cosmetic Surgery</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de la Fontaine</name>
      <address>
        <city>Loverval</city>
        <state>Hainaut</state>
        <zip>6280</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Skin Care</name>
      <address>
        <city>Sint-Truiden</city>
        <state>Limburg</state>
        <zip>3800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Liege</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kazan State Medical University</name>
      <address>
        <city>Kazan</city>
        <state>Tatarstan Republic</state>
        <zip>420105</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Centre Capital-Zdorovie</name>
      <address>
        <city>Moscow</city>
        <zip>109369</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Russian Federation</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <results_first_submitted>June 1, 2023</results_first_submitted>
  <results_first_submitted_qc>June 1, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 27, 2023</results_first_posted>
  <disposition_first_submitted>January 26, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>January 26, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">January 28, 2021</disposition_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03795922/Prot_002.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>November 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03795922/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>234 met the inclusion/exclusion criteria and were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo/MT10109L</title>
          <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
        </group>
        <group group_id="P2">
          <title>MT10109L/MT10109L</title>
          <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="154"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="129"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (Early termination, COVID, Family issue)</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>234 participants were included in the Intent To Treat (ITT) population (80 participants in the placebo group and 154 participants in the MT10109L group).</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo/MT10109L</title>
          <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
        </group>
        <group group_id="B2">
          <title>MT10109L/MT10109L</title>
          <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="80"/>
            <count group_id="B2" value="154"/>
            <count group_id="B3" value="234"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="141"/>
                    <measurement group_id="B3" value="218"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.4" spread="11.57"/>
                    <measurement group_id="B2" value="47.3" spread="12.64"/>
                    <measurement group_id="B3" value="47.0" spread="12.27"/>
                  </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="76"/>
                    <measurement group_id="B2" value="140"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="18"/>
                  </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="3"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="144"/>
                    <measurement group_id="B3" value="221"/>
                  </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_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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="222"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30</title>
        <description>The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe.&#xD;
The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.</description>
        <time_frame>Day 30</time_frame>
        <population>All primary and secondary efficacy analyses endpoints were carried out using the Intent-To-Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint. Analyses of the secondary efficacy variables were performed using observed data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30</title>
          <description>The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe.&#xD;
The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.</description>
          <population>All primary and secondary efficacy analyses endpoints were carried out using the Intent-To-Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint. Analyses of the secondary efficacy variables were performed using observed data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)</title>
        <description>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe</description>
        <time_frame>Day 30</time_frame>
        <population>All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)</title>
          <description>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe</description>
          <population>All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
                <count group_id="O2" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS)</title>
        <description>The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS).</description>
        <time_frame>Day 1 (first treatment) to Day 180</time_frame>
        <population>The analysis population for this outcome includes the participants who achieved a rating of ≥ 2-gradeimprovement from baseline in GL severity at maximum frown at Day 30 of double-blind period according to investigator assessments using the Facial Wrinkle Scale (FWS). This corresponds to the responders for Outcome 2. Note: Analyses of the secondary efficacy variables were performed using observed data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS)</title>
          <description>The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS).</description>
          <population>The analysis population for this outcome includes the participants who achieved a rating of ≥ 2-gradeimprovement from baseline in GL severity at maximum frown at Day 30 of double-blind period according to investigator assessments using the Facial Wrinkle Scale (FWS). This corresponds to the responders for Outcome 2. Note: Analyses of the secondary efficacy variables were performed using observed data.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="94"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64" lower_limit="NA" upper_limit="NA">95% Confidence Interval cannot be calculated as there was only 1 responder.</measurement>
                    <measurement group_id="O2" value="121" lower_limit="113" upper_limit="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL)</title>
        <description>The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.</description>
        <time_frame>Day 60</time_frame>
        <population>All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which wasdefined as all participants who were randomized. Analyses of the secondary efficacy variables wereperformed using observed data</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL)</title>
          <description>The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.</description>
          <population>All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which wasdefined as all participants who were randomized. Analyses of the secondary efficacy variables wereperformed using observed data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="145"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).</title>
        <description>The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.</description>
        <time_frame>Day 30</time_frame>
        <population>All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).</title>
          <description>The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.</description>
          <population>All secondary efficacy analyses were carried out using the Intent To Treat (ITT) analysis set, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration</title>
        <description>This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.</description>
        <time_frame>The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).</time_frame>
        <population>All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. Placebo participants were allowed to enter open-label phase for retreatment but the TEAEs with onset date after the retreatment were not counted here.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo participants who experienced TEAE after receiving MT10109L during open-label phase were counted here.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration</title>
          <description>This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.</description>
          <population>All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.</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="80"/>
                <count group_id="O2" value="223"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</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="73"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3" spread="13.26"/>
                    <measurement group_id="O2" value="-0.6" spread="15.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</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="73"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="10.04"/>
                    <measurement group_id="O2" value="-1.9" spread="10.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Vital Signs - Pulse Rate</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Vital Signs - Pulse Rate</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="10.35"/>
                    <measurement group_id="O2" value="0.4" spread="10.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Vital Signs - Respiratory Rate</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Vital Signs - Respiratory Rate</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>breaths/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="133"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.44"/>
                    <measurement group_id="O2" value="-0.3" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="10.38"/>
                    <measurement group_id="O2" value="2.8" spread="8.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="11.67"/>
                    <measurement group_id="O2" value="-1.2" spread="11.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="6.65"/>
                    <measurement group_id="O2" value="1.2" spread="6.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.7" spread="23.87"/>
                    <measurement group_id="O2" value="-8.4" spread="19.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="18.69"/>
                    <measurement group_id="O2" value="0.0" spread="17.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="15.43"/>
                    <measurement group_id="O2" value="-2.9" spread="14.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval</title>
        <description>Change from baseline at study exit.</description>
        <time_frame>Baseline to Study Exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval</title>
          <description>Change from baseline at study exit.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used.</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-64.6" spread="127.1"/>
                    <measurement group_id="O2" value="-39.3" spread="106.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Binding and Neutralizing Antibodies</title>
        <description>Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.</description>
        <time_frame>Up to Study Exit (Day 360 or early exit)</time_frame>
        <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo/MT10109L</title>
            <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L treatments.</description>
          </group>
          <group group_id="O2">
            <title>MT10109L/MT10109L</title>
            <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Binding and Neutralizing Antibodies</title>
          <description>Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.</description>
          <population>All safety analyses were carried out using the Safety population subset at study exit , defined as participants who received at least 1 dose of study intervention.</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="80"/>
                <count group_id="O2" value="154"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).</time_frame>
      <desc>All safety analyses were carried out using the Safety population, defined as participants who received at least 1 dose of study intervention. Placebo participants who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L Group. Thus, overall number of participants in MT10109L Group is greater than what is noted in participant flow.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1. In the open-label part post day 180, up to 2 open-label study interventions during the retreatment period. Placebo participants were allowed to enter open-label phase for retreatment but the TEAEs with onset date after the retreatment were not counted here.</description>
        </group>
        <group group_id="E2">
          <title>MT10109L</title>
          <description>MT10109L was injected into the Glabellar Lines (GL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Placebo participants who experienced TEAE after receiving MT10109L during open-label phase were counted here.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA, Version 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="223"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="223"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="223"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="223"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="223"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="223"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="223"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="223"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="223"/>
              </event>
              <event>
                <sub_title>Intentional Overdose</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="80"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="223"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="223"/>
              </event>
              <event>
                <sub_title>Breast Cancer Stage II</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="223"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma in situ</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="223"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA, Version 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="223"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="80"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="223"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="80"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="223"/>
              </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>General research agreement between the sponsor and PI's that includes a confidentiality section that includes a statement that the sponsor is and shall remain the exclusive owner of 'Information'. 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Young Ryu</name_or_title>
      <organization>Medytox Inc.</organization>
      <phone>+82-2-6901-5424</phone>
      <email>aab005@medytox.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/NCT03795922
org study id: MT10109L-001
secondary id: 2018-004384-31
nct id: NCT03795922
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in
      participants with moderate to severe GL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Percentage of Participants With a ≥ 2-grade Improvement From Baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) According to INVESTIGATOR AND PARTICIPANT Assessments of Glabellar Lines (GL) Severity at Maximum Frown at Day 30
time frame: Day 30
description: The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none and 3=severe.
The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.
measure: The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)
time frame: Day 30
description: The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe
measure: The Duration of Glabellar Lines (GL) Treatment in Participants Who Achieved a Rating of ≥ 2-grade Improvement From Baseline in GL Severity at Maximum Frown at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS)
time frame: Day 1 (first treatment) to Day 180
description: The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe GL severity at maximum frown using the FWS).
measure: The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Glabellar Lines (GL)
time frame: Day 60
description: The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.
measure: The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).
time frame: Day 30
description: The outcome was measured among participants who Were rated at least mild at rest at baseline, where a Responder was defined as achieving a ≥1-grade improvement from Baseline at Day 30 of double-blind period. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
measure: Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration
time frame: The time frame for AEs is from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).
description: This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.
measure: Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)
time frame: Baseline to Study exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)
time frame: Baseline to Study exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Vital Signs - Pulse Rate
time frame: Baseline to Study exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Vital Signs - Respiratory Rate
time frame: Baseline to Study exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
time frame: Baseline to Study Exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
time frame: Baseline to Study Exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
time frame: Baseline to Study Exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
time frame: Baseline to Study Exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
time frame: Baseline to Study Exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
time frame: Baseline to Study Exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
time frame: Baseline to Study Exit (Day 360 or early exit)
description: Change from baseline at study exit.
measure: Number of Participants With Binding and Neutralizing Antibodies
time frame: Up to Study Exit (Day 360 or early exit)
description: Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown.
arm group label: MT10109L
arm group type: Experimental
description: MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be injected into the GL: initial double-blind treatment on Day 1.
intervention type: Drug
intervention name: MT10109L
description: MT10109L will be injected into the GL.
arm group label: MT10109L
other name: NivobotulinumtoxinA
intervention type: Drug
intervention name: Placebo
description: Placebo will be injected into the GL.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: SangMi Park
role: Study Director
affiliation: Medytox Inc.
facility: 
facility: 
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facility: 
country: Belgium
country: Russian Federation
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 