<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/NCT04496167</url>
  </required_header>
  <id_info>
    <org_study_id>EN3835-210</org_study_id>
    <nct_id>NCT04496167</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of EN3835 in Participants With Frozen Shoulder</brief_title>
  <official_title>A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety and Efficacy of EN3835 for the Treatment of Adhesive Capsulitis of the Shoulder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endo Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endo Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and efficacy of EN3835 for the treatment of adhesive&#xD;
      capsulitis of the shoulder (frozen shoulder).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 29, 2020</start_date>
  <completion_date type="Actual">April 14, 2022</completion_date>
  <primary_completion_date type="Actual">April 14, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95</measure>
    <time_frame>Baseline, Day 95</time_frame>
    <description>Adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from 0 (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying total score for 10 items by 5 and then dividing it by 3, score range of 0 (no function) to 50 (full function).&#xD;
Adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score), score range of 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for Internal Rotation in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for External Rotation in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for Abduction in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for forward flexion was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for internal rotation was measured using a goniometer and a spinal level. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for external rotation was measured using a goniometer PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for abduction was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>PROM for shoulder extension was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Active Range of Motion (AROM) for Forward Flexion in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for Internal Rotation in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for External Rotation in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for Abduction in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for forward flexion was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for internal rotation was measured using a goniometer and a spinal level. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for external rotation was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for abduction was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</measure>
    <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
    <description>AROM for shoulder extension was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Adapted ASES Composite Score</measure>
    <time_frame>Baseline, Day 22, 43, and 64</time_frame>
    <description>The adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying the total score for 10 items by 5 and then dividing it by 3, score ranging from 0 (no function) to 50 (full function).&#xD;
The adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score). The range for composite score is 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Adapted ASES Function Subscale Score</measure>
    <time_frame>Baseline, Day 22, 43, 64, and 95</time_frame>
    <description>The adapted ASES function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying the total score for 10 items by 5 and then dividing it by 3, score ranging from 0 (worst no function) to 50 (full function).&#xD;
Positive change from Baseline score means an improvement in shoulder function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Adapted ASES Pain Subscale Score</measure>
    <time_frame>Baseline, Day 22, 43, 64, and 95</time_frame>
    <description>The adapted ASES pain subscale is a single item, 11-point numeric rating scale, ranging from (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Positive change from Baseline score means an improvement in shoulder pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Pain Upon Movement (PUM) Scale Score for the Affected Shoulder</measure>
    <time_frame>Baseline, Days 64 and 95</time_frame>
    <description>The PUM scale is a single item 11-point numerical rating scale of pain in the affected shoulder after AROM forward flexion, internal rotation, external rotation, abduction, and shoulder extension on a scale from 0 (no pain at all) to 10 (pain as bad as it can be). A decrease from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient-reported Global Severity of Adhesive Capsulitis Scale</measure>
    <time_frame>Baseline, Day 22, 43, 64, and 95</time_frame>
    <description>The Patient-reported Global Severity of Adhesive Capsulitis is a single item, 11-point numerical rating scale that asks participants to rate the overall severity of their adhesive capsulitis symptoms on a scale from 0 (no severity) to 10 (severe as can be). A decrease from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported Change in Severity of Adhesive Capsulitis Scale</measure>
    <time_frame>Days 22, 43, 64 and 95</time_frame>
    <description>The Patient-reported Change in Severity of Adhesive Capsulitis is a questionnaire that asks participants if their adhesive capsulitis symptoms are &quot;Better, About the Same, or Worse&quot; since the last time the questionnaire was administered. Participants who reported that their symptoms are better or worse are then asked to rate the change in their symptoms on a 7-point ordinal scale for worse and better severity. An overall severity of worse was rated from 0 (almost the same, hardly worse at all) to -6 (a very great deal worse). An overall severity of better was rated from 0 (almost the same, hardly better at all) to 6 (a very great deal better).&#xD;
Only participants with a response of 'Worse' or 'Better' were analyzed. Participants with an overall severity response of 'About the same' were excluded from the summary table below. For overall worse severity, a lower score indicated a worse outcome. For overall better severity, a higher score indicated a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Responders Assessed With Investigator Assessment of Improvement</measure>
    <time_frame>Days 64 and 95</time_frame>
    <description>Investigator assessment of improvement with treatment in the severity of the participant's treated shoulder using a 7-point Likert scale from very much worse (-3) to very much improved (3). A responder was defined as a response of &quot;very much improved&quot;, &quot;much improved&quot; or &quot;minimally improved&quot; in the investigator assessment of improvement with treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Responders Assessed by the Subject Satisfaction With Treatment Assessment</measure>
    <time_frame>Days 64 and 95</time_frame>
    <description>Participants rated their satisfaction with treatment on a 7-point Likert scale from very dissatisfied (-3) to very satisfied (3) at specified times for relief of pain in treated shoulder, relief of stiffness in treated shoulder, relief of pain in treated shoulder compared to better shoulder, and relief of stiffness in treated shoulder compared to better shoulder. A responder was defined as a participant with a response of &quot;very satisfied&quot;, &quot;satisfied&quot; or &quot;somewhat satisfied&quot; in the satisfaction with treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies</measure>
    <time_frame>Day 95</time_frame>
    <description>Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Positive for Neutralizing Antibodies</measure>
    <time_frame>Day 95</time_frame>
    <description>Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies. Only samples positive for anti-AUX-I and anti-AUX-II antibodies were analyzed for neutralizing antibodies.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Adhesive Capsulitis</condition>
  <condition>Frozen Shoulder</condition>
  <arm_group>
    <arm_group_label>EN3835</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EN3835 up to 1.74 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EN3835</intervention_name>
    <description>Collagenase clostridium histolyticum</description>
    <arm_group_label>EN3835</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo comparator</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Have idiopathic unilateral adhesive capsulitis (also known as frozen shoulder).&#xD;
&#xD;
          2. Have unaffected range of motion in the contralateral shoulder as determined by the&#xD;
             investigator.&#xD;
&#xD;
          3. Be willing to undergo x-ray and magnetic resonance imaging (MRI) of both affected and&#xD;
             unaffected shoulder.&#xD;
&#xD;
          4. Agree to participate in supervised, in-office physical therapy sessions and to&#xD;
             complete home exercises at designated time points during the study.&#xD;
&#xD;
          5. Agree to avoid general lifting and carrying during the study as instructed.&#xD;
&#xD;
          6. Be able to read, understand, and independently complete participant reported outcome&#xD;
             instruments in English.&#xD;
&#xD;
          7. If female, be of non-childbearing potential (history of hysterectomy,&#xD;
             bilateraloophorectomy, bilateral tubal ligation, or postmenopausal with no history of&#xD;
             menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing&#xD;
             potential, be non-pregnant, non-lactating and agree to use effective contraception&#xD;
             when with a male partner for the duration of the study (and for 28 days after any&#xD;
             active treatment period for participant who early terminate). Acceptable forms of&#xD;
             contraception include hormonal measures (oral contraceptive pills, contraceptive&#xD;
             patch, contraceptive ring, and injections), intrauterine devices, double barrier&#xD;
             method (condom plus diaphragm, condom or diaphragm plus spermicidal gel or foam),&#xD;
             surgical sterilization of the male partner, and abstinence.&#xD;
&#xD;
          8. If male with reproductive potential, agree to use effective contraception (abstinence,&#xD;
             surgical sterilization [vasectomy], or condom with spermicide) with a female partner&#xD;
             of child-bearing potential for the duration of the study (and for 28 days after any&#xD;
             active treatment period for participant who early terminate).&#xD;
&#xD;
          9. Be willing and able to cooperate with the requirements of the study.&#xD;
&#xD;
         10. Be adequately informed and understand the nature and risks of the study and be able to&#xD;
             provide consent .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has a known allergy to collagenase or any other excipient of EN3835 or any other&#xD;
             procedural medication (including local anesthetics).&#xD;
&#xD;
          2. Has received treatment for adhesive capsulitis (in the timeframes outlined below) or&#xD;
             is planning to receive any treatment (other than study treatment) for adhesive&#xD;
             capsulitis at any time during the study in the affected shoulder, including but not&#xD;
             limited to:&#xD;
&#xD;
               -  Physical therapy or acupuncture within 2 weeks before the first injection of&#xD;
                  study treatment.&#xD;
&#xD;
               -  Intra-articular or intrabursal injection(s) of lidocaine, suprascapular nerve&#xD;
                  blocks, or electroanalgesic and/or thermoanalgesic modalities within 1 month&#xD;
                  before the Screening Visit.&#xD;
&#xD;
               -  Intra-articular or intrabursal injection(s) of corticosteroids within 8 weeks&#xD;
                  before the Screening Visit.&#xD;
&#xD;
               -  Intra-articular or intrabursal injection(s) of sodium hyaluronate and/or&#xD;
                  glenohumeral distension arthrography within 3 months before the Screening Visit.&#xD;
&#xD;
               -  Manipulation under anaesthesia at any time prior to the study.&#xD;
&#xD;
               -  Surgery (including arthroscopic or open capsular release, capsulectomy, or&#xD;
                  capsulotomy) at any time prior to the study.&#xD;
&#xD;
          3. Has any abnormalities/conditions in the affected shoulder that would be potentially&#xD;
             confounding as determined by the central MRI review committee grading criteria.&#xD;
&#xD;
          4. Has a prosthesis or replacement of right or left shoulder, elbow, wrist, and/or hand.&#xD;
&#xD;
          5. Has systemic conditions (malignancy, hypertension, diabetes, thyroid disease,&#xD;
             thrombosis, physical impairment, infection, significant medical condition) that&#xD;
             restricts study participation.&#xD;
&#xD;
          6. Has any contraindications for MRI (implant containing metal, internal metallic object,&#xD;
             permanent cosmetics/make-up/tattoos, claustrophobia, anemia, uncontrolled&#xD;
             hypertension, epilepsy, asthma, sickle cell disease) as determined by the&#xD;
             technologist, the radiologist, and/or investigator performing the imaging, with&#xD;
             exemption of the area to be treated/reviewed.&#xD;
&#xD;
          7. Has a known coagulation disorder or is taking any medications that would increase the&#xD;
             risk of bleeding (except &lt;150 milligrams of aspirin daily), 7 days prior to first&#xD;
             injection and for the duration of the study.&#xD;
&#xD;
          8. Has received oral or parenteral steroids for any reason within 3 weeks before the&#xD;
             Screening Visit.&#xD;
&#xD;
          9. Has, at any time, received collagenase for the treatment of adhesive capsulitis&#xD;
             (including participant who received treatment in Study AUX-CC-870 or AUX-CC-871).&#xD;
&#xD;
         10. Has received treatment with an investigational product within 30 days (or 5 half&#xD;
             lives, whichever is longer) of the screening visit.&#xD;
&#xD;
         11. Has received collagenase treatments (for example, Santyl® ointment and/or&#xD;
             XIAFLEX/XIAPEX®) for any other indication within 30 days prior to study treatment&#xD;
             administration, or is planning to be treated with collagenase (other than study&#xD;
             treatment) at any time during the study.&#xD;
&#xD;
         12. Has donated blood within 30 days prior to the Screening Visit or has plans to donate&#xD;
             blood during the study.&#xD;
&#xD;
         13. Has a corrected QT interval (QTc) of ≥ 450 milliseconds (ms) for male participant or&#xD;
             ≥470 ms for female participant on the screening electrocardiogram (ECG).&#xD;
&#xD;
         14. Is from a vulnerable population, as defined by the US Code of Federal Regulations&#xD;
             (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations,&#xD;
             including but not limited to, employees (temporary, part-time, full-time, etc) or a&#xD;
             family member of the research staff conducting the study, or of the sponsor, or of the&#xD;
             contract research organization, or of the Institutional Review Board (IRB)/Independent&#xD;
             Ethics Committee (IEC).&#xD;
&#xD;
         15. Has concurrent diseases that might interfere with the conduct of the study, confound&#xD;
             the interpretation of the study results, or endanger the participant's well-being,&#xD;
             (for example, evidence of any significant hematological, endocrine, cardiovascular,&#xD;
             respiratory, neurological, renal, hepatic, or gastrointestinal disease). If there is a&#xD;
             history of such disease but the condition has been stable for more than 5 year(s) and&#xD;
             is judged by the investigator not to interfere with the participant's participation in&#xD;
             the study, the participant may be included, with the documented approval of the&#xD;
             Medical Monitor.&#xD;
&#xD;
         16. Has any other condition(s) that, in the investigator's opinion, might indicate the&#xD;
             participant to be unsuitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Ortega, MD</last_name>
    <role>Study Director</role>
    <affiliation>Endo Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #38</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>32505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #24</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #9</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #29</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #12</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #16</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #18</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #14</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #37</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #33</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #3</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #32</name>
      <address>
        <city>Clermont</city>
        <state>Florida</state>
        <zip>34711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #13</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #1</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #2</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #20</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #34</name>
      <address>
        <city>Dalton</city>
        <state>Georgia</state>
        <zip>30720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #26</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #30</name>
      <address>
        <city>Newnan</city>
        <state>Georgia</state>
        <zip>30265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #28</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #31</name>
      <address>
        <city>Oak Brook</city>
        <state>Illinois</state>
        <zip>60523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #35</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #8</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #10</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #21</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #36</name>
      <address>
        <city>Mooresville</city>
        <state>North Carolina</state>
        <zip>28117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #6</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #11</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #7</name>
      <address>
        <city>Indiana</city>
        <state>Pennsylvania</state>
        <zip>15701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #5</name>
      <address>
        <city>State College</city>
        <state>Pennsylvania</state>
        <zip>16801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #17</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #19</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #15</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #27</name>
      <address>
        <city>Georgetown</city>
        <state>Texas</state>
        <zip>78628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #25</name>
      <address>
        <city>Laredo</city>
        <state>Texas</state>
        <zip>78041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #23</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #22</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Endo Clinical Trial Site #4</name>
      <address>
        <city>Danville</city>
        <state>Virginia</state>
        <zip>24541</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <results_first_submitted>April 14, 2023</results_first_submitted>
  <results_first_submitted_qc>August 15, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">September 13, 2023</results_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bursitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 22, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT04496167/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 25, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT04496167/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>EN3835</title>
          <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least 1 Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Than Specified</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who received at least 1 injection of study treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>EN3835</title>
          <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
            <count group_id="B2" value="94"/>
            <count group_id="B3" value="195"/>
          </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="53.76" spread="7.565"/>
                    <measurement group_id="B2" value="55.50" spread="7.806"/>
                    <measurement group_id="B3" value="54.59" spread="7.712"/>
                  </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="65"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="131"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other Race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple Race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95</title>
        <description>Adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from 0 (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying total score for 10 items by 5 and then dividing it by 3, score range of 0 (no function) to 50 (full function).&#xD;
Adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score), score range of 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.</description>
        <time_frame>Baseline, Day 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment and had both Baseline and Day 95 measurements. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95</title>
          <description>Adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from 0 (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying total score for 10 items by 5 and then dividing it by 3, score range of 0 (no function) to 50 (full function).&#xD;
Adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score), score range of 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment and had both Baseline and Day 95 measurements. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.35" spread="22.432"/>
                    <measurement group_id="O2" value="41.16" spread="21.942"/>
                  </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>Mixed Model Repeated Measures (MMRM) was performed to estimate the change from Baseline treatment effect of the adapted ASES composite score in the affected shoulder comparing EN3835 to placebo treatment.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.659</p_value>
            <p_value_desc>Considered significant if p-value is less than 0.05.</p_value_desc>
            <method>MMRM</method>
            <param_type>Least Square Mean Treatment Difference</param_type>
            <param_value>1.386</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.804</ci_lower_limit>
            <ci_upper_limit>7.577</ci_upper_limit>
            <estimate_desc>The model included treatment, visit and interaction of treatment, visit as fixed effects, Baseline as a covariate, and repeated measures with visit/participant.&#xD;
Treatment difference: EN3835 - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder</title>
        <description>PROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder</title>
          <description>PROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" spread="24.88"/>
                    <measurement group_id="O2" value="13.9" spread="22.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6" spread="26.89"/>
                    <measurement group_id="O2" value="21.4" spread="20.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" spread="26.31"/>
                    <measurement group_id="O2" value="27.3" spread="23.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.8" spread="25.59"/>
                    <measurement group_id="O2" value="29.7" spread="27.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for Internal Rotation in the Affected Shoulder</title>
        <description>PROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for Internal Rotation in the Affected Shoulder</title>
          <description>PROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" spread="23.95"/>
                    <measurement group_id="O2" value="7.0" spread="17.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" spread="25.97"/>
                    <measurement group_id="O2" value="12.4" spread="19.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.0" spread="24.65"/>
                    <measurement group_id="O2" value="18.3" spread="21.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" spread="22.59"/>
                    <measurement group_id="O2" value="21.6" spread="23.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for External Rotation in the Affected Shoulder</title>
        <description>PROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for External Rotation in the Affected Shoulder</title>
          <description>PROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="19.39"/>
                    <measurement group_id="O2" value="8.8" spread="15.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" spread="20.98"/>
                    <measurement group_id="O2" value="14.5" spread="18.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="24.87"/>
                    <measurement group_id="O2" value="17.8" spread="17.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" spread="21.24"/>
                    <measurement group_id="O2" value="19.2" spread="18.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for Abduction in the Affected Shoulder</title>
        <description>PROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for Abduction in the Affected Shoulder</title>
          <description>PROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="28.47"/>
                    <measurement group_id="O2" value="13.1" spread="23.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.6" spread="30.19"/>
                    <measurement group_id="O2" value="18.9" spread="27.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6" spread="36.76"/>
                    <measurement group_id="O2" value="31.1" spread="29.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1" spread="38.17"/>
                    <measurement group_id="O2" value="36.0" spread="33.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder</title>
        <description>PROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder</title>
          <description>PROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="16.51"/>
                    <measurement group_id="O2" value="5.7" spread="13.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.0" spread="18.34"/>
                    <measurement group_id="O2" value="9.2" spread="16.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" spread="18.44"/>
                    <measurement group_id="O2" value="12.0" spread="17.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3" spread="18.30"/>
                    <measurement group_id="O2" value="14.7" spread="17.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>PROM for forward flexion was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>PROM for forward flexion was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.48" spread="29.067"/>
                    <measurement group_id="O2" value="-37.33" spread="27.179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.34" spread="27.939"/>
                    <measurement group_id="O2" value="-30.24" spread="26.369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.14" spread="27.983"/>
                    <measurement group_id="O2" value="-23.01" spread="24.200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.82" spread="26.245"/>
                    <measurement group_id="O2" value="-21.06" spread="25.198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>PROM for internal rotation was measured using a goniometer and a spinal level. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>PROM for internal rotation was measured using a goniometer and a spinal level. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.76" spread="24.692"/>
                    <measurement group_id="O2" value="-28.51" spread="24.930"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.81" spread="24.950"/>
                    <measurement group_id="O2" value="-22.03" spread="24.311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.50" spread="21.561"/>
                    <measurement group_id="O2" value="-16.88" spread="24.096"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.22" spread="21.444"/>
                    <measurement group_id="O2" value="-13.49" spread="26.037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>PROM for external rotation was measured using a goniometer PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>PROM for external rotation was measured using a goniometer PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.12" spread="22.928"/>
                    <measurement group_id="O2" value="-35.49" spread="23.027"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.30" spread="25.102"/>
                    <measurement group_id="O2" value="-29.40" spread="25.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-24.46" spread="26.063"/>
                    <measurement group_id="O2" value="-26.08" spread="24.494"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.94" spread="22.153"/>
                    <measurement group_id="O2" value="-25.06" spread="23.844"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>PROM for abduction was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>PROM for abduction was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-54.90" spread="40.162"/>
                    <measurement group_id="O2" value="-57.56" spread="35.565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-41.37" spread="39.918"/>
                    <measurement group_id="O2" value="-53.17" spread="36.106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.87" spread="39.860"/>
                    <measurement group_id="O2" value="-41.48" spread="37.136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-28.91" spread="41.483"/>
                    <measurement group_id="O2" value="-36.54" spread="41.288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>PROM for shoulder extension was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>PROM for shoulder extension was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-18.82" spread="21.558"/>
                    <measurement group_id="O2" value="-17.11" spread="19.106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.99" spread="22.313"/>
                    <measurement group_id="O2" value="-14.01" spread="20.363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.97" spread="22.633"/>
                    <measurement group_id="O2" value="-9.91" spread="18.869"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.87" spread="20.756"/>
                    <measurement group_id="O2" value="-7.33" spread="17.676"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Active Range of Motion (AROM) for Forward Flexion in the Affected Shoulder</title>
        <description>AROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Active Range of Motion (AROM) for Forward Flexion in the Affected Shoulder</title>
          <description>AROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" spread="26.28"/>
                    <measurement group_id="O2" value="13.0" spread="26.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.9" spread="30.00"/>
                    <measurement group_id="O2" value="22.3" spread="26.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" spread="25.47"/>
                    <measurement group_id="O2" value="29.6" spread="28.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7" spread="25.31"/>
                    <measurement group_id="O2" value="30.1" spread="31.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for Internal Rotation in the Affected Shoulder</title>
        <description>AROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for Internal Rotation in the Affected Shoulder</title>
          <description>AROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="20.45"/>
                    <measurement group_id="O2" value="5.8" spread="19.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="22.13"/>
                    <measurement group_id="O2" value="10.2" spread="20.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" spread="22.44"/>
                    <measurement group_id="O2" value="17.5" spread="21.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6" spread="21.99"/>
                    <measurement group_id="O2" value="21.6" spread="23.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for External Rotation in the Affected Shoulder</title>
        <description>AROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>All randomized participants who received at least 1 injection of study treatment who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment and had both Baseline and measurements at specified timepoints.</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for External Rotation in the Affected Shoulder</title>
          <description>AROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.</description>
          <population>All randomized participants who received at least 1 injection of study treatment who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment and had both Baseline and measurements at specified timepoints.</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" spread="16.85"/>
                    <measurement group_id="O2" value="5.6" spread="14.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" spread="19.59"/>
                    <measurement group_id="O2" value="10.0" spread="19.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9" spread="22.18"/>
                    <measurement group_id="O2" value="15.4" spread="21.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="21.67"/>
                    <measurement group_id="O2" value="16.1" spread="21.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for Abduction in the Affected Shoulder</title>
        <description>AROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for Abduction in the Affected Shoulder</title>
          <description>AROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2" spread="30.75"/>
                    <measurement group_id="O2" value="13.7" spread="23.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="37.79"/>
                    <measurement group_id="O2" value="22.2" spread="27.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.2" spread="35.60"/>
                    <measurement group_id="O2" value="33.3" spread="30.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0" spread="37.71"/>
                    <measurement group_id="O2" value="39.8" spread="31.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder</title>
        <description>AROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder</title>
          <description>AROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="17.37"/>
                    <measurement group_id="O2" value="8.5" spread="15.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.7" spread="21.63"/>
                    <measurement group_id="O2" value="12.0" spread="16.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" spread="19.29"/>
                    <measurement group_id="O2" value="15.3" spread="16.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" spread="19.91"/>
                    <measurement group_id="O2" value="17.3" spread="17.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>AROM for forward flexion was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>AROM for forward flexion was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-38.34" spread="30.007"/>
                    <measurement group_id="O2" value="-40.72" spread="24.602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.00" spread="29.397"/>
                    <measurement group_id="O2" value="-32.17" spread="24.879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-23.62" spread="29.115"/>
                    <measurement group_id="O2" value="-23.82" spread="23.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.83" spread="26.729"/>
                    <measurement group_id="O2" value="-23.39" spread="24.774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>AROM for internal rotation was measured using a goniometer and a spinal level. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>AROM for internal rotation was measured using a goniometer and a spinal level. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.53" spread="24.699"/>
                    <measurement group_id="O2" value="-27.94" spread="24.757"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-29.78" spread="24.728"/>
                    <measurement group_id="O2" value="-23.45" spread="24.923"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.57" spread="23.335"/>
                    <measurement group_id="O2" value="-16.99" spread="24.708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.27" spread="23.646"/>
                    <measurement group_id="O2" value="-12.66" spread="27.685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>AROM for external rotation was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>AROM for external rotation was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-34.78" spread="25.743"/>
                    <measurement group_id="O2" value="-35.82" spread="22.666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-31.07" spread="29.543"/>
                    <measurement group_id="O2" value="-31.23" spread="23.379"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.31" spread="28.454"/>
                    <measurement group_id="O2" value="-25.84" spread="26.291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.52" spread="26.313"/>
                    <measurement group_id="O2" value="-25.42" spread="26.075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>AROM for abduction was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>AROM for abduction was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-58.41" spread="38.888"/>
                    <measurement group_id="O2" value="-57.28" spread="36.353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.14" spread="41.198"/>
                    <measurement group_id="O2" value="-49.32" spread="34.988"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.08" spread="36.868"/>
                    <measurement group_id="O2" value="-39.82" spread="38.397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.74" spread="38.227"/>
                    <measurement group_id="O2" value="-33.01" spread="39.718"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
        <description>AROM for shoulder extension was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
        <time_frame>Baseline, Days 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline</title>
          <description>AROM for shoulder extension was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.&#xD;
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder&#xD;
Change from baseline was calculated as:&#xD;
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>degrees</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.65" spread="19.893"/>
                    <measurement group_id="O2" value="-15.25" spread="21.385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.55" spread="20.771"/>
                    <measurement group_id="O2" value="-11.65" spread="20.674"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="78"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.29" spread="20.214"/>
                    <measurement group_id="O2" value="-6.94" spread="20.775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.00" spread="18.904"/>
                    <measurement group_id="O2" value="-5.34" spread="20.922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Adapted ASES Composite Score</title>
        <description>The adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying the total score for 10 items by 5 and then dividing it by 3, score ranging from 0 (no function) to 50 (full function).&#xD;
The adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score). The range for composite score is 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.</description>
        <time_frame>Baseline, Day 22, 43, and 64</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Adapted ASES Composite Score</title>
          <description>The adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying the total score for 10 items by 5 and then dividing it by 3, score ranging from 0 (no function) to 50 (full function).&#xD;
The adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score). The range for composite score is 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.87" spread="15.684"/>
                    <measurement group_id="O2" value="15.96" spread="14.269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.15" spread="21.532"/>
                    <measurement group_id="O2" value="21.77" spread="18.199"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.21" spread="22.837"/>
                    <measurement group_id="O2" value="34.98" spread="21.222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Adapted ASES Function Subscale Score</title>
        <description>The adapted ASES function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying the total score for 10 items by 5 and then dividing it by 3, score ranging from 0 (worst no function) to 50 (full function).&#xD;
Positive change from Baseline score means an improvement in shoulder function.</description>
        <time_frame>Baseline, Day 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Adapted ASES Function Subscale Score</title>
          <description>The adapted ASES function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying the total score for 10 items by 5 and then dividing it by 3, score ranging from 0 (worst no function) to 50 (full function).&#xD;
Positive change from Baseline score means an improvement in shoulder function.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.56" spread="8.245"/>
                    <measurement group_id="O2" value="7.96" spread="7.388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.82" spread="10.365"/>
                    <measurement group_id="O2" value="11.77" spread="9.964"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.60" spread="12.127"/>
                    <measurement group_id="O2" value="17.98" spread="11.337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.05" spread="11.538"/>
                    <measurement group_id="O2" value="20.73" spread="11.823"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Adapted ASES Pain Subscale Score</title>
        <description>The adapted ASES pain subscale is a single item, 11-point numeric rating scale, ranging from (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Positive change from Baseline score means an improvement in shoulder pain.</description>
        <time_frame>Baseline, Day 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Adapted ASES Pain Subscale Score</title>
          <description>The adapted ASES pain subscale is a single item, 11-point numeric rating scale, ranging from (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Positive change from Baseline score means an improvement in shoulder pain.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="9.61"/>
                    <measurement group_id="O2" value="8.0" spread="9.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="12.73"/>
                    <measurement group_id="O2" value="10.0" spread="11.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.6" spread="12.67"/>
                    <measurement group_id="O2" value="17.0" spread="12.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3" spread="13.11"/>
                    <measurement group_id="O2" value="20.4" spread="12.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Pain Upon Movement (PUM) Scale Score for the Affected Shoulder</title>
        <description>The PUM scale is a single item 11-point numerical rating scale of pain in the affected shoulder after AROM forward flexion, internal rotation, external rotation, abduction, and shoulder extension on a scale from 0 (no pain at all) to 10 (pain as bad as it can be). A decrease from Baseline indicates improvement.</description>
        <time_frame>Baseline, Days 64 and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Pain Upon Movement (PUM) Scale Score for the Affected Shoulder</title>
          <description>The PUM scale is a single item 11-point numerical rating scale of pain in the affected shoulder after AROM forward flexion, internal rotation, external rotation, abduction, and shoulder extension on a scale from 0 (no pain at all) to 10 (pain as bad as it can be). A decrease from Baseline indicates improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.6" spread="2.60"/>
                    <measurement group_id="O2" value="-3.0" spread="2.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.1" spread="2.59"/>
                    <measurement group_id="O2" value="-3.8" spread="2.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient-reported Global Severity of Adhesive Capsulitis Scale</title>
        <description>The Patient-reported Global Severity of Adhesive Capsulitis is a single item, 11-point numerical rating scale that asks participants to rate the overall severity of their adhesive capsulitis symptoms on a scale from 0 (no severity) to 10 (severe as can be). A decrease from Baseline indicates improvement.</description>
        <time_frame>Baseline, Day 22, 43, 64, and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient-reported Global Severity of Adhesive Capsulitis Scale</title>
          <description>The Patient-reported Global Severity of Adhesive Capsulitis is a single item, 11-point numerical rating scale that asks participants to rate the overall severity of their adhesive capsulitis symptoms on a scale from 0 (no severity) to 10 (severe as can be). A decrease from Baseline indicates improvement.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="1.84"/>
                    <measurement group_id="O2" value="-1.5" spread="1.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="2.21"/>
                    <measurement group_id="O2" value="-2.3" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" spread="2.41"/>
                    <measurement group_id="O2" value="-3.6" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="2.48"/>
                    <measurement group_id="O2" value="-4.0" spread="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient-reported Change in Severity of Adhesive Capsulitis Scale</title>
        <description>The Patient-reported Change in Severity of Adhesive Capsulitis is a questionnaire that asks participants if their adhesive capsulitis symptoms are &quot;Better, About the Same, or Worse&quot; since the last time the questionnaire was administered. Participants who reported that their symptoms are better or worse are then asked to rate the change in their symptoms on a 7-point ordinal scale for worse and better severity. An overall severity of worse was rated from 0 (almost the same, hardly worse at all) to -6 (a very great deal worse). An overall severity of better was rated from 0 (almost the same, hardly better at all) to 6 (a very great deal better).&#xD;
Only participants with a response of 'Worse' or 'Better' were analyzed. Participants with an overall severity response of 'About the same' were excluded from the summary table below. For overall worse severity, a lower score indicated a worse outcome. For overall better severity, a higher score indicated a better outcome.</description>
        <time_frame>Days 22, 43, 64 and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had measurement at specified timepoint).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient-reported Change in Severity of Adhesive Capsulitis Scale</title>
          <description>The Patient-reported Change in Severity of Adhesive Capsulitis is a questionnaire that asks participants if their adhesive capsulitis symptoms are &quot;Better, About the Same, or Worse&quot; since the last time the questionnaire was administered. Participants who reported that their symptoms are better or worse are then asked to rate the change in their symptoms on a 7-point ordinal scale for worse and better severity. An overall severity of worse was rated from 0 (almost the same, hardly worse at all) to -6 (a very great deal worse). An overall severity of better was rated from 0 (almost the same, hardly better at all) to 6 (a very great deal better).&#xD;
Only participants with a response of 'Worse' or 'Better' were analyzed. Participants with an overall severity response of 'About the same' were excluded from the summary table below. For overall worse severity, a lower score indicated a worse outcome. For overall better severity, a higher score indicated a better outcome.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had measurement at specified timepoint).</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22: Worse Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.4" spread="1.52"/>
                    <measurement group_id="O2" value="-3.2" spread="2.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: Better Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.40"/>
                    <measurement group_id="O2" value="2.5" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Worse Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="1.53"/>
                    <measurement group_id="O2" value="-4.0" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43: Better Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="65"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="1.46"/>
                    <measurement group_id="O2" value="3.6" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64: Worse Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-4.8" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64: Better Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="69"/>
                    <count group_id="O2" value="64"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.29"/>
                    <measurement group_id="O2" value="4.2" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95: Worse Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-3.5" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95: Better Severity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="72"/>
                    <count group_id="O2" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="1.27"/>
                    <measurement group_id="O2" value="4.7" spread="1.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Responders Assessed With Investigator Assessment of Improvement</title>
        <description>Investigator assessment of improvement with treatment in the severity of the participant's treated shoulder using a 7-point Likert scale from very much worse (-3) to very much improved (3). A responder was defined as a response of &quot;very much improved&quot;, &quot;much improved&quot; or &quot;minimally improved&quot; in the investigator assessment of improvement with treatment.</description>
        <time_frame>Days 64 and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had measurement at specified timepoint).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responders Assessed With Investigator Assessment of Improvement</title>
          <description>Investigator assessment of improvement with treatment in the severity of the participant's treated shoulder using a 7-point Likert scale from very much worse (-3) to very much improved (3). A responder was defined as a response of &quot;very much improved&quot;, &quot;much improved&quot; or &quot;minimally improved&quot; in the investigator assessment of improvement with treatment.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had measurement at specified timepoint).</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="82"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 64</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Responders Assessed by the Subject Satisfaction With Treatment Assessment</title>
        <description>Participants rated their satisfaction with treatment on a 7-point Likert scale from very dissatisfied (-3) to very satisfied (3) at specified times for relief of pain in treated shoulder, relief of stiffness in treated shoulder, relief of pain in treated shoulder compared to better shoulder, and relief of stiffness in treated shoulder compared to better shoulder. A responder was defined as a participant with a response of &quot;very satisfied&quot;, &quot;satisfied&quot; or &quot;somewhat satisfied&quot; in the satisfaction with treatment.</description>
        <time_frame>Days 64 and 95</time_frame>
        <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had measurement at specified timepoint).</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responders Assessed by the Subject Satisfaction With Treatment Assessment</title>
          <description>Participants rated their satisfaction with treatment on a 7-point Likert scale from very dissatisfied (-3) to very satisfied (3) at specified times for relief of pain in treated shoulder, relief of stiffness in treated shoulder, relief of pain in treated shoulder compared to better shoulder, and relief of stiffness in treated shoulder compared to better shoulder. A responder was defined as a participant with a response of &quot;very satisfied&quot;, &quot;satisfied&quot; or &quot;somewhat satisfied&quot; in the satisfaction with treatment.</description>
          <population>Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had measurement at specified timepoint).</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="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 64: Pain relief in treated shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64: Stiffness relief in treated shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64: Pain relief in treated shoulder compared to better shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 64: Stiffness relief in treated shoulder compared to better shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95: Pain relief in treated shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95: Stiffness relief in treated shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95: Pain relief in treated shoulder compared to better shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 95: Stiffness relief in treated shoulder compared to better shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies</title>
        <description>Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies.</description>
        <time_frame>Day 95</time_frame>
        <population>Safety population included all participants who received at least 1 dose of study drug and had an assessment at the specified timepoint. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies</title>
          <description>Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies.</description>
          <population>Safety population included all participants who received at least 1 dose of study drug and had an assessment at the specified timepoint. Here, overall number of participants analyzed = participants evaluable for this outcome measure.</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="83"/>
                <count group_id="O2" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Anti-AUX-I Antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti-AUX-II Antibodies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Positive for Neutralizing Antibodies</title>
        <description>Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies. Only samples positive for anti-AUX-I and anti-AUX-II antibodies were analyzed for neutralizing antibodies.</description>
        <time_frame>Day 95</time_frame>
        <population>All participants who received at least 1 dose of study drug, were positive for anti-AUX-I and anti-AUX-II antibodies and had an assessment at the specified timepoint. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Only samples positive for anti-AUX-I and anti-AUX-II antibodies were analyzed for neutralizing antibodies.</population>
        <group_list>
          <group group_id="O1">
            <title>EN3835</title>
            <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Positive for Neutralizing Antibodies</title>
          <description>Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies. Only samples positive for anti-AUX-I and anti-AUX-II antibodies were analyzed for neutralizing antibodies.</description>
          <population>All participants who received at least 1 dose of study drug, were positive for anti-AUX-I and anti-AUX-II antibodies and had an assessment at the specified timepoint. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Only samples positive for anti-AUX-I and anti-AUX-II antibodies were analyzed for neutralizing antibodies.</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="83"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Neutralizing AUX-I Antibodies</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutralizing AUX-II Antibodies</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 1 (after dosing) through Day 95</time_frame>
      <desc>Safety population included all participants who received at least 1 dose of study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>EN3835</title>
          <description>Participants received EN3835 (up to 1.74 mg total) by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="94"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="94"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Operations</name_or_title>
      <organization>Endo Pharmaceuticals</organization>
      <phone>800-462-3636</phone>
      <email>clinicaltrials@endo.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/NCT04496167
org study id: EN3835-210
nct id: NCT04496167
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will evaluate the safety and efficacy of EN3835 for the treatment of adhesive
      capsulitis of the shoulder (frozen shoulder).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95
time frame: Baseline, Day 95
description: Adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from 0 (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying total score for 10 items by 5 and then dividing it by 3, score range of 0 (no function) to 50 (full function).
Adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score), score range of 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.
measure: Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.
measure: Change From Baseline in PROM for Internal Rotation in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement.
measure: Change From Baseline in PROM for External Rotation in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.
measure: Change From Baseline in PROM for Abduction in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.
measure: Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.
measure: Change From Baseline in PROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for forward flexion was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in PROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for internal rotation was measured using a goniometer and a spinal level. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in PROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for external rotation was measured using a goniometer PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in PROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for abduction was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: PROM for shoulder extension was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in Active Range of Motion (AROM) for Forward Flexion in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.
measure: Change From Baseline in AROM for Internal Rotation in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement.
measure: Change From Baseline in AROM for External Rotation in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.
measure: Change From Baseline in AROM for Abduction in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.
measure: Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.
measure: Change From Baseline in AROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for forward flexion was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in AROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for internal rotation was measured using a goniometer and a spinal level. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in AROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for external rotation was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in AROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for abduction was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline
time frame: Baseline, Days 22, 43, 64, and 95
description: AROM for shoulder extension was measured using a goniometer. AROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. AROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95.
Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder
Change from baseline was calculated as:
(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value
measure: Change From Baseline in the Adapted ASES Composite Score
time frame: Baseline, Day 22, 43, and 64
description: The adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying the total score for 10 items by 5 and then dividing it by 3, score ranging from 0 (no function) to 50 (full function).
The adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score). The range for composite score is 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.
measure: Change From Baseline in the Adapted ASES Function Subscale Score
time frame: Baseline, Day 22, 43, 64, and 95
description: The adapted ASES function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying the total score for 10 items by 5 and then dividing it by 3, score ranging from 0 (worst no function) to 50 (full function).
Positive change from Baseline score means an improvement in shoulder function.
measure: Change From Baseline in the Adapted ASES Pain Subscale Score
time frame: Baseline, Day 22, 43, 64, and 95
description: The adapted ASES pain subscale is a single item, 11-point numeric rating scale, ranging from (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Positive change from Baseline score means an improvement in shoulder pain.
measure: Change From Baseline in the Pain Upon Movement (PUM) Scale Score for the Affected Shoulder
time frame: Baseline, Days 64 and 95
description: The PUM scale is a single item 11-point numerical rating scale of pain in the affected shoulder after AROM forward flexion, internal rotation, external rotation, abduction, and shoulder extension on a scale from 0 (no pain at all) to 10 (pain as bad as it can be). A decrease from Baseline indicates improvement.
measure: Change From Baseline in Patient-reported Global Severity of Adhesive Capsulitis Scale
time frame: Baseline, Day 22, 43, 64, and 95
description: The Patient-reported Global Severity of Adhesive Capsulitis is a single item, 11-point numerical rating scale that asks participants to rate the overall severity of their adhesive capsulitis symptoms on a scale from 0 (no severity) to 10 (severe as can be). A decrease from Baseline indicates improvement.
measure: Patient-reported Change in Severity of Adhesive Capsulitis Scale
time frame: Days 22, 43, 64 and 95
description: The Patient-reported Change in Severity of Adhesive Capsulitis is a questionnaire that asks participants if their adhesive capsulitis symptoms are "Better, About the Same, or Worse" since the last time the questionnaire was administered. Participants who reported that their symptoms are better or worse are then asked to rate the change in their symptoms on a 7-point ordinal scale for worse and better severity. An overall severity of worse was rated from 0 (almost the same, hardly worse at all) to -6 (a very great deal worse). An overall severity of better was rated from 0 (almost the same, hardly better at all) to 6 (a very great deal better).
Only participants with a response of 'Worse' or 'Better' were analyzed. Participants with an overall severity response of 'About the same' were excluded from the summary table below. For overall worse severity, a lower score indicated a worse outcome. For overall better severity, a higher score indicated a better outcome.
measure: Number of Responders Assessed With Investigator Assessment of Improvement
time frame: Days 64 and 95
description: Investigator assessment of improvement with treatment in the severity of the participant's treated shoulder using a 7-point Likert scale from very much worse (-3) to very much improved (3). A responder was defined as a response of "very much improved", "much improved" or "minimally improved" in the investigator assessment of improvement with treatment.
measure: Number of Responders Assessed by the Subject Satisfaction With Treatment Assessment
time frame: Days 64 and 95
description: Participants rated their satisfaction with treatment on a 7-point Likert scale from very dissatisfied (-3) to very satisfied (3) at specified times for relief of pain in treated shoulder, relief of stiffness in treated shoulder, relief of pain in treated shoulder compared to better shoulder, and relief of stiffness in treated shoulder compared to better shoulder. A responder was defined as a participant with a response of "very satisfied", "satisfied" or "somewhat satisfied" in the satisfaction with treatment.
measure: Number of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies
time frame: Day 95
description: Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies.
measure: Number of Participants Positive for Neutralizing Antibodies
time frame: Day 95
description: Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies. Only samples positive for anti-AUX-I and anti-AUX-II antibodies were analyzed for neutralizing antibodies.
arm group label: EN3835
arm group type: Experimental
description: EN3835 up to 1.74 mg
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: EN3835
description: Collagenase clostridium histolyticum
arm group label: EN3835
intervention type: Drug
intervention name: Placebo
description: Placebo comparator
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luis Ortega, MD
role: Study Director
affiliation: Endo Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Bursitis
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 