<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/NCT02253147</url>
  </required_header>
  <id_info>
    <org_study_id>TEO-RHA-1402</org_study_id>
    <nct_id>NCT02253147</nct_id>
  </id_info>
  <brief_title>TEOSYAL® RHA Ultra Deep and Perlane-L® for the Correction of Nasolabial Folds</brief_title>
  <official_title>A Controlled, Randomized, Double-Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA (Resilient Hyaluronic Acid) Ultra Deep Versus Perlane-L® in the Treatment of Moderate to Severe Nasolabial Folds</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Teoxane SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ethica Clinical Research Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Teoxane SA</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effectiveness and safety of TEOSYAL® RHA Ultra&#xD;
      Deep versus Perlane-L® in the treatment of moderate to severe nasolabial folds. This is a&#xD;
      controlled, randomized, double-blinded, within subject (split-face), multicenter, prospective&#xD;
      clinical study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.</measure>
    <time_frame>Baseline and 24 weeks after last treatment</time_frame>
    <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.&#xD;
BLE =Blinded Live Evaluator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®</measure>
    <time_frame>During 14 days after initial treatment (D0) and touch-up (2 weeks)</time_frame>
    <description>The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).&#xD;
The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and &quot;other&quot;.&#xD;
The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate &quot;other&quot; if the subject experienced a sign/symptom that is not listed.&#xD;
The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®</measure>
    <time_frame>During Injection and 5, 15, 30 minutes post-injection</time_frame>
    <description>VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)</measure>
    <time_frame>Baseline and Weeks 24, 36, 52, 64</time_frame>
    <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)</measure>
    <time_frame>Baseline and Weeks 2, 4, 12, 24, 36, 52, 64</time_frame>
    <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE</measure>
    <time_frame>Baseline and Weeks 24, 36, 52, 64</time_frame>
    <description>A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to Baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI</measure>
    <time_frame>Baseline and Weeks 2, 4, 12, 24, 36, 52, 64</time_frame>
    <description>A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Scored Either &quot;Much Improved&quot; or &quot;Improved&quot; on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)</measure>
    <time_frame>Weeks 24, 36, 52, 64</time_frame>
    <description>Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of &quot;much improved, improved, no change, worse, and much worse&quot;.&#xD;
GAI was assessed using the baseline photograph. Each side of the face was assessed independently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either &quot;Much Improved&quot; or &quot;Improved&quot;) on GAI Scale.</measure>
    <time_frame>Weeks 4, 12, 24, 36, 52, 64</time_frame>
    <description>Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of &quot;much improved, improved, no change, worse, and much worse&quot;.&#xD;
GAI was assessed using the baseline photograph. Subjects will be instructed: &quot;Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale&quot;.&#xD;
Each side of the face was assessed independently.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire</measure>
    <time_frame>Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64</time_frame>
    <description>The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.&#xD;
FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').&#xD;
The subject was instructed as follows: &quot;These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:&quot;, and provided response.&#xD;
How deep your nasolabial fold are?&#xD;
How your nasolabial folds look when your face is relaxed (still)?&#xD;
How old your nasolabial folds make you look?&#xD;
How your nasolabial folds look when you smile?&#xD;
How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Satisfaction Score</measure>
    <time_frame>Weeks 2, 4, 12, 24, 36, 52, 64</time_frame>
    <description>Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)</measure>
    <time_frame>Week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Receiving Touch-up Treatment</measure>
    <time_frame>Week 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Receiving Re-treatment</measure>
    <time_frame>Weeks 24, 36, 52, 64</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Nasolabial Folds, Wrinkles</condition>
  <arm_group>
    <arm_group_label>Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Split-face injection of TEOSYAL® RHA Ultra Deep into the left Naso Labial Folds (NLFs) and Perlane-L® into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Split-face injection of Perlane-L® into the left Naso Labial Folds (NLFs) and TEOSYAL® RHA Ultra Deep into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TEOSYAL® RHA Ultra Deep</intervention_name>
    <description>A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27Gauge ½&quot; disposable sterile needles.</description>
    <arm_group_label>Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep</arm_group_label>
    <arm_group_label>Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatient, male or female of any race, 22 years of age or older; female subjects of&#xD;
             childbearing potential must have a negative Urine Pregnancy Test and practice a&#xD;
             reliable method of contraception;&#xD;
&#xD;
          -  NLFs classified as WSRS grade 3 or 4 (same score for each side);&#xD;
&#xD;
          -  Willing to abstain from facial aesthetic procedures/therapies that could interfere&#xD;
             with study evaluations;&#xD;
&#xD;
          -  Able to follow study instructions and likely to complete all required visits;&#xD;
&#xD;
          -  Signed informed consent and HIPAA form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subjects that are pregnant, breast-feeding or of childbearing potential and not&#xD;
             practicing reliable birth control;&#xD;
&#xD;
          -  Known hypersensitivity/allergy to any component of the study devices;&#xD;
&#xD;
          -  Known sensitivity to local anesthetics of the amide type, history of multiple severe&#xD;
             allergies, history of anaphylactic shock;&#xD;
&#xD;
          -  Known susceptibility to keloid formation, hypertrophic scarring or clinically&#xD;
             significant skin pigmentation disorders;&#xD;
&#xD;
          -  Clinically significant active skin disease within 6 months;&#xD;
&#xD;
          -  History of active chronic debilitating systemic disease;&#xD;
&#xD;
          -  History of connective tissue disease;&#xD;
&#xD;
          -  History of malignancy (excl. non-melanoma skin cancer) within past 5 years;&#xD;
&#xD;
          -  History of bleeding disorders;&#xD;
&#xD;
          -  Need for clinically significant and continuous medical treatment within 2 weeks prior&#xD;
             to first visit;&#xD;
&#xD;
          -  Received/used a prohibited treatment/procedure within certain time periods (e.g.,&#xD;
             bioresorbable fillers, NSAIDS, ASA, high dose vitamin E, corticosteroids, interferon,&#xD;
             anti-coagulation therapies, laser/light therapies, botulinum toxin injections&#xD;
             (frontalis and glabella complex treatment permitted), prescription strength topical&#xD;
             retinoids, facial peels, excisional facial surgery, clinically significant oral or&#xD;
             maxillofacial surgery).&#xD;
&#xD;
          -  Evidence of clinically significant alcohol or drug abuse, or history of poor&#xD;
             cooperation, non-compliance with medical treatment, or unreliability&#xD;
&#xD;
          -  Exhibit a physical attribute(s) that may prevent assessment or treatment of NLFs such&#xD;
             as excessive facial hair, traumatic or surgical facial scars, and/or excessive&#xD;
             hyperpigmentation in the treatment areas.&#xD;
&#xD;
          -  A condition or situation that may put the subject at significant risk, confound the&#xD;
             study results, or significantly interfere with the subject participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>United States</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United States</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United States</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United States</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <results_first_submitted>November 21, 2017</results_first_submitted>
  <results_first_submitted_qc>February 27, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">March 27, 2018</results_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nasolabial folds</keyword>
  <keyword>Dermal filler</keyword>
  <keyword>Hyaluronic acid (HA)</keyword>
  <keyword>Wrinkles</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 120 were randomized for a split-face injection of RHA Ultra Deep and Perlane-L.&#xD;
20 subjects were randomized to an untreated group (recruited only to avoid Blinded Live Evaluator to be biased so, not presented)</recruitment_details>
      <pre_assignment_details>2 subjects randomized to the RHA UD/Perlane discontinued participation prior to receiving study treatment (N=118) 2 subjects randomized to the untreated group received injections with RHA UD/Perlane. These subjects were placed in the SAFT population for safety evaluations (SAFT population n=120)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TEOSYAL® RHA Ultra Deep / Perlane-L®</title>
          <description>Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).&#xD;
TEOSYAL® RHA Ultra Deep: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G½&quot; disposable sterile needles.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>N Patients at W24 (Primary Outcome)</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>N Patients at W36</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>N Patients at W52</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not consent to study extension</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Conditional re-treatment at W52</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TEOSYAL® RHA Ultra Deep / Perlane-L®</title>
          <description>Split-face injection of TEOSYAL® RHA Ultra Deep into one NLF and Perlane-L® into the contralateral NLF. Up to 3.0 mL injected per NLF (deep-dermis to superficial subcutaneous). Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).&#xD;
TEOSYAL® RHA Ultra Deep: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G½&quot; disposable sterile needles.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="118"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.4" spread="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </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="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Skin Type</title>
          <description>The Fitzpatrick scale is a numerical classification schema for human skin color.&#xD;
Type I - always burns, never tans (pale white; blond or red hair; blue eyes; freckles).&#xD;
Type II - usually burns, tans minimally (white; fair; blond or red hair; blue, green, or hazel eyes) Type III - sometimes mild burn, tans uniformly (cream white; fair with any hair or eye color) Type IV - burns minimally, always tans well (moderate brown) Type V - very rarely burns, tans very easily (dark brown) Type VI - Never burns, never tans (deeply pigmented dark brown to darkest brown)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Types I to III</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Types IV to VI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.</title>
        <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.&#xD;
BLE =Blinded Live Evaluator</description>
        <time_frame>Baseline and 24 weeks after last treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.</title>
          <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.&#xD;
BLE =Blinded Live Evaluator</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" lower_limit="-1.46" upper_limit="-1.22"/>
                    <measurement group_id="O2" value="-1.16" lower_limit="-1.29" upper_limit="-1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Efficacy of TEOSYAL® RHA Ultra Deep versus control is analyzed in a non-inferiority statistical model using the 5-grade Wrinkle Severity Rating Scale (WSRS) as rated by the Blinded Live Evaluator at 24 weeks after baseline.&#xD;
The primary endpoint is the aesthetic improvement from pre-injection of the NLF at the side of the face treated with TEOSYAL® RHA Ultra Deep compared to the one at the side of the face treated with the control device, as assessed by the BLE at 24 weeks after baseline.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>A WSRS change of 1 grade is considered to be clinically significant. A difference of ≤0.5 grade between the two treatment groups (i.e., half of the clinically significant difference) = non-inferiority margin.&#xD;
The primary efficacy endpoint uses a paired-design and is analyzed by calculating two-sided confidence intervals of the mean difference between TEOSYAL® RHA UD and the control device, between the V1 enrollment visit (baseline) and V7 (24 weeks after baseline).</non_inferiority_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.34</ci_lower_limit>
            <ci_upper_limit>-0.11</ci_upper_limit>
            <estimate_desc>The decision is based on the upper limit of the 2-sided confidence interval for the difference for the change from baseline, between test and comparator treatment. For achieving non-inferiority, the upper confidence limit of a 95.0% CI must be ≤0.5</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®</title>
        <description>The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).&#xD;
The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and &quot;other&quot;.&#xD;
The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate &quot;other&quot; if the subject experienced a sign/symptom that is not listed.&#xD;
The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)</description>
        <time_frame>During 14 days after initial treatment (D0) and touch-up (2 weeks)</time_frame>
        <population>CTR are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (RHA-UD N=32/Perl N=47)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®</title>
          <description>The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).&#xD;
The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and &quot;other&quot;.&#xD;
The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate &quot;other&quot; if the subject experienced a sign/symptom that is not listed.&#xD;
The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)</description>
          <population>CTR are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for CTR after touch-up treatment are based on number of patients receiving Touch-up treatment (RHA-UD N=32/Perl N=47)</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="120"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bruising (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bruising (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discolouration (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discolouration (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Firmness (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Firmness (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumps/Bumps (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lumps/Bumps (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness (initial treatment)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tenderness (Touch-up)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®</title>
        <description>VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain</description>
        <time_frame>During Injection and 5, 15, 30 minutes post-injection</time_frame>
        <population>VAS are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for pain assessment after touch-up treatment are based on number of patients receiving Touch-up treatment</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®</title>
          <description>VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain</description>
          <population>VAS are presented for the SAFT population (N=120) (see pre-assignment details) Number of patients for pain assessment after touch-up treatment are based on number of patients receiving Touch-up treatment</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Initial injection mean pain during injection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.43" spread="21.15"/>
                    <measurement group_id="O2" value="23.85" spread="21.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial injection mean pain 5 min post-injection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.22" spread="12.37"/>
                    <measurement group_id="O2" value="5.33" spread="12.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial injection mean pain 15 min post-injection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="7.38"/>
                    <measurement group_id="O2" value="2.82" spread="8.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Initial injection mean pain 30 min post-injection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="120"/>
                    <count group_id="O2" value="120"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.83" spread="7.31"/>
                    <measurement group_id="O2" value="1.65" spread="7.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Touch-up injection mean pain during injection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.63" spread="23.06"/>
                    <measurement group_id="O2" value="23.34" spread="19.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Touch-up injection mean pain 5 min post-injection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.88" spread="14.46"/>
                    <measurement group_id="O2" value="5.30" spread="8.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Touch-up injection mean pain 15 min post-injection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.56" spread="6.48"/>
                    <measurement group_id="O2" value="2.62" spread="4.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Touch-up injection mean pain 30 min post-injection</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="47"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.81" spread="4.49"/>
                    <measurement group_id="O2" value="1.38" spread="3.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)</title>
        <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.</description>
        <time_frame>Baseline and Weeks 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)</title>
          <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.</description>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>W24 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.34" spread="0.57"/>
                    <measurement group_id="O2" value="-1.16" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.28" spread="0.63"/>
                    <measurement group_id="O2" value="-1.12" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.23" spread="0.74"/>
                    <measurement group_id="O2" value="-1.05" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.26" spread="0.71"/>
                    <measurement group_id="O2" value="-1.11" spread="0.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)</title>
        <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.</description>
        <time_frame>Baseline and Weeks 2, 4, 12, 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)</title>
          <description>WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.</description>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>W2 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.77" spread="0.60"/>
                    <measurement group_id="O2" value="-1.51" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W4 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.85" spread="0.58"/>
                    <measurement group_id="O2" value="-1.60" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W12 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.70" spread="0.78"/>
                    <measurement group_id="O2" value="-1.34" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W24 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.45" spread="0.76"/>
                    <measurement group_id="O2" value="-1.05" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.50" spread="0.78"/>
                    <measurement group_id="O2" value="-1.16" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.38" spread="0.71"/>
                    <measurement group_id="O2" value="-0.99" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64 Delta from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.32" spread="0.82"/>
                    <measurement group_id="O2" value="-1.03" spread="0.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE</title>
        <description>A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to Baseline</description>
        <time_frame>Baseline and Weeks 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE</title>
          <description>A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to Baseline</description>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
          <units>percentage of responders</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>W24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" lower_limit="92.0" upper_limit="99.7"/>
                    <measurement group_id="O2" value="88.6" lower_limit="80.1" upper_limit="94.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.7" lower_limit="82.5" upper_limit="95.9"/>
                    <measurement group_id="O2" value="87.2" lower_limit="78.3" upper_limit="93.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.0" lower_limit="77.4" upper_limit="94.0"/>
                    <measurement group_id="O2" value="83.1" lower_limit="72.9" upper_limit="90.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2" lower_limit="79.1" upper_limit="95.6"/>
                    <measurement group_id="O2" value="84.6" lower_limit="73.5" upper_limit="92.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI</title>
        <description>A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline</description>
        <time_frame>Baseline and Weeks 2, 4, 12, 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI</title>
          <description>A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline</description>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
          <units>percentage of responders</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>W2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" lower_limit="92.0" upper_limit="99.7"/>
                    <measurement group_id="O2" value="93.2" lower_limit="85.8" upper_limit="97.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="95.9" upper_limit="100.0"/>
                    <measurement group_id="O2" value="97.7" lower_limit="92.0" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5" lower_limit="88.8" upper_limit="98.8"/>
                    <measurement group_id="O2" value="88.6" lower_limit="80.1" upper_limit="94.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.9" lower_limit="82.9" upper_limit="96.0"/>
                    <measurement group_id="O2" value="78.4" lower_limit="68.4" upper_limit="86.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.7" lower_limit="82.5" upper_limit="95.9"/>
                    <measurement group_id="O2" value="83.7" lower_limit="74.2" upper_limit="90.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9" lower_limit="85.1" upper_limit="97.3"/>
                    <measurement group_id="O2" value="77.4" lower_limit="67.0" upper_limit="85.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.1" lower_limit="72.3" upper_limit="91.0"/>
                    <measurement group_id="O2" value="76.1" lower_limit="64.5" upper_limit="85.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Scored Either &quot;Much Improved&quot; or &quot;Improved&quot; on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)</title>
        <description>Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of &quot;much improved, improved, no change, worse, and much worse&quot;.&#xD;
GAI was assessed using the baseline photograph. Each side of the face was assessed independently.</description>
        <time_frame>Weeks 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Scored Either &quot;Much Improved&quot; or &quot;Improved&quot; on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)</title>
          <description>Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of &quot;much improved, improved, no change, worse, and much worse&quot;.&#xD;
GAI was assessed using the baseline photograph. Each side of the face was assessed independently.</description>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See 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="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>W24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either &quot;Much Improved&quot; or &quot;Improved&quot;) on GAI Scale.</title>
        <description>Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of &quot;much improved, improved, no change, worse, and much worse&quot;.&#xD;
GAI was assessed using the baseline photograph. Subjects will be instructed: &quot;Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale&quot;.&#xD;
Each side of the face was assessed independently.</description>
        <time_frame>Weeks 4, 12, 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either &quot;Much Improved&quot; or &quot;Improved&quot;) on GAI Scale.</title>
          <description>Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of &quot;much improved, improved, no change, worse, and much worse&quot;.&#xD;
GAI was assessed using the baseline photograph. Subjects will be instructed: &quot;Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale&quot;.&#xD;
Each side of the face was assessed independently.</description>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See 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="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>W4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire</title>
        <description>The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.&#xD;
FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').&#xD;
The subject was instructed as follows: &quot;These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:&quot;, and provided response.&#xD;
How deep your nasolabial fold are?&#xD;
How your nasolabial folds look when your face is relaxed (still)?&#xD;
How old your nasolabial folds make you look?&#xD;
How your nasolabial folds look when you smile?&#xD;
How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome.</description>
        <time_frame>Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire</title>
          <description>The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.&#xD;
FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').&#xD;
The subject was instructed as follows: &quot;These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:&quot;, and provided response.&#xD;
How deep your nasolabial fold are?&#xD;
How your nasolabial folds look when your face is relaxed (still)?&#xD;
How old your nasolabial folds make you look?&#xD;
How your nasolabial folds look when you smile?&#xD;
How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome.</description>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7" spread="19.2"/>
                    <measurement group_id="O2" value="25.7" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1" spread="23.3"/>
                    <measurement group_id="O2" value="74.0" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.3" spread="21.0"/>
                    <measurement group_id="O2" value="81.2" spread="21.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.1" spread="22.3"/>
                    <measurement group_id="O2" value="74.4" spread="25.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.9" spread="22.3"/>
                    <measurement group_id="O2" value="66.1" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.9" spread="25.0"/>
                    <measurement group_id="O2" value="61.5" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.0" spread="25.6"/>
                    <measurement group_id="O2" value="65.9" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.7" spread="24.0"/>
                    <measurement group_id="O2" value="64.2" spread="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Satisfaction Score</title>
        <description>Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'</description>
        <time_frame>Weeks 2, 4, 12, 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Satisfaction Score</title>
          <description>Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'</description>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits and for which data were available (See participant flow)</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>W2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.49" spread="0.61"/>
                    <measurement group_id="O2" value="1.63" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="0.57"/>
                    <measurement group_id="O2" value="1.31" spread="0.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.41" spread="0.62"/>
                    <measurement group_id="O2" value="1.62" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="87"/>
                    <count group_id="O2" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.53" spread="0.66"/>
                    <measurement group_id="O2" value="1.79" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.64" spread="0.75"/>
                    <measurement group_id="O2" value="1.95" spread="0.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="0.70"/>
                    <measurement group_id="O2" value="1.77" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="70"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.40" spread="0.60"/>
                    <measurement group_id="O2" value="1.67" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)</title>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)</title>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.79" spread="0.87"/>
                    <measurement group_id="O2" value="1.75" spread="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Receiving Touch-up Treatment</title>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Receiving Touch-up Treatment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Receiving Re-treatment</title>
        <time_frame>Weeks 24, 36, 52, 64</time_frame>
        <population>Numbers of patients analyzed correspond to patients that have completed the visits (See participant flow)</population>
        <group_list>
          <group group_id="O1">
            <title>TEOSYAL® RHA Ultra Deep</title>
            <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
          </group>
          <group group_id="O2">
            <title>Perlane-L®</title>
            <description>Injection of Perlane-L® into the controlateral NLF</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Receiving Re-treatment</title>
          <population>Numbers of patients analyzed correspond to patients that have completed the visits (See 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="88"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>W24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>W64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="71"/>
                    <count group_id="O2" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>64 weeks or 68 weeks for patients receiving a re-treatment at W64</time_frame>
      <desc>The TI assessed all AEs and recorded details of seriousness, severity, duration, and action taken with study device, and relationship to the study device.&#xD;
Adverse Events are presented for the SAFT population (N=120) (see pre-assignment details)</desc>
      <group_list>
        <group group_id="E1">
          <title>TEOSYAL® RHA Ultra Deep</title>
          <description>Injection of TEOSYAL® RHA Ultra Deep into one NLF</description>
        </group>
        <group group_id="E2">
          <title>Perlane-L®</title>
          <description>Injection of Perlane-L® into the controlateral NLF</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <description>unrelated to the study device</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <description>unrelated to the study device</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung Infection</sub_title>
                <description>unrelated to the study device</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="75" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Lumps/Bumps</sub_title>
                <counts group_id="E1" events="52" subjects_affected="45" subjects_at_risk="120"/>
                <counts group_id="E2" events="43" subjects_affected="34" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Injection site firmness</sub_title>
                <counts group_id="E1" events="52" subjects_affected="45" subjects_at_risk="120"/>
                <counts group_id="E2" events="39" subjects_affected="34" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="28" subjects_affected="24" subjects_at_risk="120"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Tenderness</sub_title>
                <counts group_id="E1" events="22" subjects_affected="19" subjects_at_risk="120"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Injection site discolouration</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="120"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="120"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="120"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="120"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="120"/>
                <counts group_id="E2" events="10" subjects_affected="6" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="120"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Telangiectasia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="120"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="120"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Project Manager</name_or_title>
      <organization>Teoxane</organization>
      <phone>+41 (0) 22 344 96 36</phone>
      <email>m.chenet@teoxane.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/NCT02253147
org study id: TEO-RHA-1402
nct id: NCT02253147
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the effectiveness and safety of TEOSYAL® RHA Ultra
      Deep versus Perlane-L® in the treatment of moderate to severe nasolabial folds. This is a
      controlled, randomized, double-blinded, within subject (split-face), multicenter, prospective
      clinical study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Non-inferiority of the Delta of the WSRS Score Between W24 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe Naso-Labial Folds Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the BLE.
time frame: Baseline and 24 weeks after last treatment
description: WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
BLE =Blinded Live Evaluator
measure: Post Injection Treatment Responses (From Common Treatment Responses (CTR) Diary) for Safety Evaluation of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
time frame: During 14 days after initial treatment (D0) and touch-up (2 weeks)
description: The subjects received a diary booklet and instructions for recording his/her observations of the Common Treatment Responses of the study treatments for the first 14 days after each treatment (initial, touch-up). The diary was discussed during each telephone follow-up visit. Subjects should complete the diary at approximately the same time each day (i.e., am or pm).
The subject diary captured the following Common Treatment Responses (CTR) that occur following the injection of a dermal filler; specifically, redness, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and "other".
The 14-day patient CTR diary included a detailed glossary describing all signs/symptoms listed in the diary; an option was provided to rate "other" if the subject experienced a sign/symptom that is not listed.
The table presents the number of subjects experiencing at least 1 Common Treatment Response (CTR)
measure: Assessment of Injection Site Pain (Visual Analog Scale) of TEOSYAL® RHA Ultra Deep Versus Perlane-L®
time frame: During Injection and 5, 15, 30 minutes post-injection
description: VAS is a 100 mm Visual Analog Scale with 0 meaning no pain and 100 meaning intolerable pain
measure: Delta of the WSRS Score Between W24,36,52 and 64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Blinded Live Evaluator (BLE)
time frame: Baseline and Weeks 24, 36, 52, 64
description: WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
measure: Delta of the WSRS Score Between W2,4,12,24,36,52,64 and Baseline for TEOSYAL® RHA Ultra Deep Versus Perlane-L® for the Correction of Moderate to Severe NLFs Based on the Wrinkle Severity Rating Scale (WSRS) Score Assessed by the Treating Investigator (TI)
time frame: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
description: WSRS (Wrinkle Severity Rating Scale) is a validated 5-point scale with 1 being 'absent' and 5 being 'extreme'.
measure: Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the BLE
time frame: Baseline and Weeks 24, 36, 52, 64
description: A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to Baseline
measure: Percentage of Responders Based on the Intra-individual Improvement of at Least One Grade in the Wrinkle Severity Rating Scale (WSRS) Compared to Baseline Assessed by the TI
time frame: Baseline and Weeks 2, 4, 12, 24, 36, 52, 64
description: A responder correspond to a subject with an intra-individual improvement of at least one grade in the WSRS compared to baseline
measure: Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) by the Blinded Live Evaluator (BLE)
time frame: Weeks 24, 36, 52, 64
description: Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
GAI was assessed using the baseline photograph. Each side of the face was assessed independently.
measure: Number of Global Aesthetic Improvement (GAI) Responders (i.e., Scoring Either "Much Improved" or "Improved") on GAI Scale.
time frame: Weeks 4, 12, 24, 36, 52, 64
description: Global Aesthetic Improvement (GAI) is a subjective 5-grade scale comprised of "much improved, improved, no change, worse, and much worse".
GAI was assessed using the baseline photograph. Subjects will be instructed: "Use a mirror to compare your face to the photograph provided to you and rate the degree of aesthetic improvement by using the following scale".
Each side of the face was assessed independently.
measure: Subject's Perception of Treatment Effectiveness as Per the FACE-Q (NLF Domain) Questionnaire
time frame: Immediately post-injection, and weeks 2, 4, 12, 24, 36, 52, 64
description: The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being 'Not at all' and 4 being 'Extremely').
The subject was instructed as follows: "These questions ask about how you look right now. With your nasolabial folds in mind (the deep lines that run downward from the sides of your nose), in the past week, how much have you been bothered by:", and provided response.
How deep your nasolabial fold are?
How your nasolabial folds look when your face is relaxed (still)?
How old your nasolabial folds make you look?
How your nasolabial folds look when you smile?
How your nasolabial folds look compared with other people your age? To calculate the FACE-Q, outcomes from all 5 questions were pooled and adapted to a scale to 100 units. Data were also transformed so that higher scores reflected a beneficial outcome.
measure: Subject's Satisfaction Score
time frame: Weeks 2, 4, 12, 24, 36, 52, 64
description: Subjective 5-point scale with 1 being 'very satisfied' and 5 being 'very dissatisfied'
measure: Volume to Obtain Optimal Cosmetic Result (Initial Treatment + Touch-up)
time frame: Week 2
measure: Number of Subjects Receiving Touch-up Treatment
time frame: Week 2
measure: Number of Subjects Receiving Re-treatment
time frame: Weeks 24, 36, 52, 64
arm group label: Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L®
arm group type: Experimental
description: Split-face injection of TEOSYAL® RHA Ultra Deep into the left Naso Labial Folds (NLFs) and Perlane-L® into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
arm group label: Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep
arm group type: Experimental
description: Split-face injection of Perlane-L® into the left Naso Labial Folds (NLFs) and TEOSYAL® RHA Ultra Deep into the right NLF (n=120). Up to 3.0 mL injected per NLF. Touch-up treatment provided at 2 weeks (up to 3.0 mL per NLF).
intervention type: Device
intervention name: TEOSYAL® RHA Ultra Deep
description: A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27Gauge ½" disposable sterile needles.
arm group label: Left side Perlane-L®, Right side TEOSYAL® RHA Ultra Deep
arm group label: Left side TEOSYAL® RHA Ultra Deep, Right side Perlane-L®
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 