Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT04496167
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2020-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of EN3835 in Participants With Frozen Shoulder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002062', 'term': 'Bursitis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@endo.com', 'phone': '800-462-3636', 'title': 'Clinical Operations', 'organization': 'Endo Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Day 1 (after dosing) through Day 95', 'description': 'Safety population included all participants who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'EN3835', '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.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 69, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.', 'otherNumAtRisk': 94, 'deathsNumAtRisk': 94, 'otherNumAffected': 22, 'seriousNumAtRisk': 94, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'seriousEvents': [{'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 94, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.35', 'spread': '22.432', 'groupId': 'OG000'}, {'value': '41.16', 'spread': '21.942', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.659', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.386', 'ciLowerLimit': '-4.804', 'ciUpperLimit': '7.577', 'pValueComment': 'Considered significant if p-value is less than 0.05.', 'estimateComment': 'The model included treatment, visit and interaction of treatment, visit as fixed effects, Baseline as a covariate, and repeated measures with visit/participant.\n\nTreatment difference: EN3835 - Placebo', 'groupDescription': '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.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '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).\n\nAdapted 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '24.88', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '22.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.6', 'spread': '26.89', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '20.14', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.4', 'spread': '26.31', 'groupId': 'OG000'}, {'value': '27.3', 'spread': '23.68', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.8', 'spread': '25.59', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '27.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 64, and 95', 'description': 'PROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for Internal Rotation in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '23.95', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '17.94', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '25.97', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '19.92', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.0', 'spread': '24.65', 'groupId': 'OG000'}, {'value': '18.3', 'spread': '21.95', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.9', 'spread': '22.59', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '23.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for External Rotation in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '19.39', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '15.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.2', 'spread': '20.98', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '18.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.4', 'spread': '24.87', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '17.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '21.24', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '18.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 64, and 95', 'description': 'PROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for Abduction in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '28.47', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '23.89', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.6', 'spread': '30.19', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '27.13', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.6', 'spread': '36.76', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '29.27', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.1', 'spread': '38.17', 'groupId': 'OG000'}, {'value': '36.0', 'spread': '33.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 64, and 95', 'description': 'PROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '16.51', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '13.54', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '18.34', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '16.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.2', 'spread': '18.44', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '17.23', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '18.30', 'groupId': 'OG000'}, {'value': '14.7', 'spread': '17.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 64, and 95', 'description': 'PROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.48', 'spread': '29.067', 'groupId': 'OG000'}, {'value': '-37.33', 'spread': '27.179', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.34', 'spread': '27.939', 'groupId': 'OG000'}, {'value': '-30.24', 'spread': '26.369', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.14', 'spread': '27.983', 'groupId': 'OG000'}, {'value': '-23.01', 'spread': '24.200', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.82', 'spread': '26.245', 'groupId': 'OG000'}, {'value': '-21.06', 'spread': '25.198', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-30.76', 'spread': '24.692', 'groupId': 'OG000'}, {'value': '-28.51', 'spread': '24.930', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-26.81', 'spread': '24.950', 'groupId': 'OG000'}, {'value': '-22.03', 'spread': '24.311', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.50', 'spread': '21.561', 'groupId': 'OG000'}, {'value': '-16.88', 'spread': '24.096', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.22', 'spread': '21.444', 'groupId': 'OG000'}, {'value': '-13.49', 'spread': '26.037', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-35.12', 'spread': '22.928', 'groupId': 'OG000'}, {'value': '-35.49', 'spread': '23.027', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.30', 'spread': '25.102', 'groupId': 'OG000'}, {'value': '-29.40', 'spread': '25.727', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.46', 'spread': '26.063', 'groupId': 'OG000'}, {'value': '-26.08', 'spread': '24.494', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.94', 'spread': '22.153', 'groupId': 'OG000'}, {'value': '-25.06', 'spread': '23.844', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-54.90', 'spread': '40.162', 'groupId': 'OG000'}, {'value': '-57.56', 'spread': '35.565', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-41.37', 'spread': '39.918', 'groupId': 'OG000'}, {'value': '-53.17', 'spread': '36.106', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.87', 'spread': '39.860', 'groupId': 'OG000'}, {'value': '-41.48', 'spread': '37.136', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-28.91', 'spread': '41.483', 'groupId': 'OG000'}, {'value': '-36.54', 'spread': '41.288', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.82', 'spread': '21.558', 'groupId': 'OG000'}, {'value': '-17.11', 'spread': '19.106', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-14.99', 'spread': '22.313', 'groupId': 'OG000'}, {'value': '-14.01', 'spread': '20.363', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.97', 'spread': '22.633', 'groupId': 'OG000'}, {'value': '-9.91', 'spread': '18.869', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.87', 'spread': '20.756', 'groupId': 'OG000'}, {'value': '-7.33', 'spread': '17.676', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Active Range of Motion (AROM) for Forward Flexion in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '26.28', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '26.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.9', 'spread': '30.00', 'groupId': 'OG000'}, {'value': '22.3', 'spread': '26.17', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.7', 'spread': '25.47', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '28.85', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.7', 'spread': '25.31', 'groupId': 'OG000'}, {'value': '30.1', 'spread': '31.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 64, and 95', 'description': 'AROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for Internal Rotation in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '20.45', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '19.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '22.13', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '20.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '22.44', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '21.55', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.6', 'spread': '21.99', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '23.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for External Rotation in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '16.85', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '14.79', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '19.59', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '19.12', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '22.18', 'groupId': 'OG000'}, {'value': '15.4', 'spread': '21.65', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.8', 'spread': '21.67', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '21.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 64, and 95', 'description': 'AROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for Abduction in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.2', 'spread': '30.75', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '23.17', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '37.79', 'groupId': 'OG000'}, {'value': '22.2', 'spread': '27.93', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '35.60', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '30.53', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '37.71', 'groupId': 'OG000'}, {'value': '39.8', 'spread': '31.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 64, and 95', 'description': 'AROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '17.37', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '15.84', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.7', 'spread': '21.63', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '16.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '19.29', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '16.70', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '19.91', 'groupId': 'OG000'}, {'value': '17.3', 'spread': '17.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 64, and 95', 'description': 'AROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-38.34', 'spread': '30.007', 'groupId': 'OG000'}, {'value': '-40.72', 'spread': '24.602', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.00', 'spread': '29.397', 'groupId': 'OG000'}, {'value': '-32.17', 'spread': '24.879', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.62', 'spread': '29.115', 'groupId': 'OG000'}, {'value': '-23.82', 'spread': '23.083', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.83', 'spread': '26.729', 'groupId': 'OG000'}, {'value': '-23.39', 'spread': '24.774', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-30.53', 'spread': '24.699', 'groupId': 'OG000'}, {'value': '-27.94', 'spread': '24.757', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-29.78', 'spread': '24.728', 'groupId': 'OG000'}, {'value': '-23.45', 'spread': '24.923', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.57', 'spread': '23.335', 'groupId': 'OG000'}, {'value': '-16.99', 'spread': '24.708', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.27', 'spread': '23.646', 'groupId': 'OG000'}, {'value': '-12.66', 'spread': '27.685', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-34.78', 'spread': '25.743', 'groupId': 'OG000'}, {'value': '-35.82', 'spread': '22.666', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-31.07', 'spread': '29.543', 'groupId': 'OG000'}, {'value': '-31.23', 'spread': '23.379', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-25.31', 'spread': '28.454', 'groupId': 'OG000'}, {'value': '-25.84', 'spread': '26.291', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.52', 'spread': '26.313', 'groupId': 'OG000'}, {'value': '-25.42', 'spread': '26.075', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-58.41', 'spread': '38.888', 'groupId': 'OG000'}, {'value': '-57.28', 'spread': '36.353', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-46.14', 'spread': '41.198', 'groupId': 'OG000'}, {'value': '-49.32', 'spread': '34.988', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-35.08', 'spread': '36.868', 'groupId': 'OG000'}, {'value': '-39.82', 'spread': '38.397', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-30.74', 'spread': '38.227', 'groupId': 'OG000'}, {'value': '-33.01', 'spread': '39.718', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in AROM for Shoulder Extension in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.65', 'spread': '19.893', 'groupId': 'OG000'}, {'value': '-15.25', 'spread': '21.385', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.55', 'spread': '20.771', 'groupId': 'OG000'}, {'value': '-11.65', 'spread': '20.674', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.29', 'spread': '20.214', 'groupId': 'OG000'}, {'value': '-6.94', 'spread': '20.775', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'spread': '18.904', 'groupId': 'OG000'}, {'value': '-5.34', 'spread': '20.922', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Adapted ASES Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.87', 'spread': '15.684', 'groupId': 'OG000'}, {'value': '15.96', 'spread': '14.269', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.15', 'spread': '21.532', 'groupId': 'OG000'}, {'value': '21.77', 'spread': '18.199', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.21', 'spread': '22.837', 'groupId': 'OG000'}, {'value': '34.98', 'spread': '21.222', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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).\n\nThe 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Adapted ASES Function Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.56', 'spread': '8.245', 'groupId': 'OG000'}, {'value': '7.96', 'spread': '7.388', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.82', 'spread': '10.365', 'groupId': 'OG000'}, {'value': '11.77', 'spread': '9.964', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.60', 'spread': '12.127', 'groupId': 'OG000'}, {'value': '17.98', 'spread': '11.337', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.05', 'spread': '11.538', 'groupId': 'OG000'}, {'value': '20.73', 'spread': '11.823', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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).\n\nPositive change from Baseline score means an improvement in shoulder function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Adapted ASES Pain Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '9.49', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '12.73', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '11.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '12.67', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '12.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '13.11', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '12.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Pain Upon Movement (PUM) Scale Score for the Affected Shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '2.72', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.1', 'spread': '2.59', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '2.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient-reported Global Severity of Adhesive Capsulitis Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.87', 'groupId': 'OG001'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.4', 'spread': '2.48', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '2.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Patient-reported Change in Severity of Adhesive Capsulitis Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 22: Worse Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '2.23', 'groupId': 'OG001'}]}]}, {'title': 'Day 22: Better Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.29', 'groupId': 'OG001'}]}]}, {'title': 'Day 43: Worse Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '1.53', 'groupId': 'OG000'}, {'value': '-4.0', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Day 43: Better Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Day 64: Worse Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'Day 64: Better Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '1.40', 'groupId': 'OG001'}]}]}, {'title': 'Day 95: Worse Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.5', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Day 95: Better Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '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).\n\nOnly 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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Number of Responders Assessed With Investigator Assessment of Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Day 95', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Number of Responders Assessed by the Subject Satisfaction With Treatment Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Day 64: Pain relief in treated shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Day 64: Stiffness relief in treated shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Day 64: Pain relief in treated shoulder compared to better shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Day 64: Stiffness relief in treated shoulder compared to better shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Day 95: Pain relief in treated shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Day 95: Stiffness relief in treated shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Day 95: Pain relief in treated shoulder compared to better shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Day 95: Stiffness relief in treated shoulder compared to better shoulder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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).'}, {'type': 'SECONDARY', 'title': 'Number of Participants Positive for Anti-AUX-I and Anti-AUX-II Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Anti-AUX-I Antibodies', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Anti-AUX-II Antibodies', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 95', 'description': 'Serum samples were collected and tested for the presence of anti-AUX-I and anti-AUX-II antibodies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Positive for Neutralizing Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN3835', '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.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'classes': [{'title': 'Neutralizing AUX-I Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neutralizing AUX-II Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EN3835', '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.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '94'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other Than Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'EN3835', '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.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo by pericapsular (periarticular) injection in up to 3 treatment sessions at least 21 days apart.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.76', 'spread': '7.565', 'groupId': 'BG000'}, {'value': '55.50', 'spread': '7.806', 'groupId': 'BG001'}, {'value': '54.59', 'spread': '7.712', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}, {'title': 'Other Race', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Multiple Race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received at least 1 injection of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-22', 'size': 1617737, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-13T19:12', 'hasProtocol': True}, {'date': '2022-04-25', 'size': 974366, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-13T19:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2020-07-29', 'resultsFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-15', 'studyFirstPostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '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).\n\nAdapted 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.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(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', 'timeFrame': '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.\n\nBaseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder\n\nChange from baseline was calculated as:\n\n(Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value'}, {'measure': 'Change From Baseline in the Adapted ASES Composite Score', 'timeFrame': '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).\n\nThe 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', 'timeFrame': '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).\n\nPositive change from Baseline score means an improvement in shoulder function.'}, {'measure': 'Change From Baseline in the Adapted ASES Pain Subscale Score', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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).\n\nOnly 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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adhesive Capsulitis', 'Frozen Shoulder']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of EN3835 for the treatment of adhesive capsulitis of the shoulder (frozen shoulder).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Have idiopathic unilateral adhesive capsulitis (also known as frozen shoulder).\n2. Have unaffected range of motion in the contralateral shoulder as determined by the investigator.\n3. Be willing to undergo x-ray and magnetic resonance imaging (MRI) of both affected and unaffected shoulder.\n4. Agree to participate in supervised, in-office physical therapy sessions and to complete home exercises at designated time points during the study.\n5. Agree to avoid general lifting and carrying during the study as instructed.\n6. Be able to read, understand, and independently complete participant reported outcome instruments in English.\n7. If female, be of non-childbearing potential (history of hysterectomy, bilateraloophorectomy, bilateral tubal ligation, or postmenopausal with no history of menstrual flow in the 12 months prior to the Screening Visit); or, if of childbearing potential, be non-pregnant, non-lactating and agree to use effective contraception when with a male partner for the duration of the study (and for 28 days after any active treatment period for participant who early terminate). Acceptable forms of contraception include hormonal measures (oral contraceptive pills, contraceptive patch, contraceptive ring, and injections), intrauterine devices, double barrier method (condom plus diaphragm, condom or diaphragm plus spermicidal gel or foam), surgical sterilization of the male partner, and abstinence.\n8. If male with reproductive potential, agree to use effective contraception (abstinence, surgical sterilization \\[vasectomy\\], or condom with spermicide) with a female partner of child-bearing potential for the duration of the study (and for 28 days after any active treatment period for participant who early terminate).\n9. Be willing and able to cooperate with the requirements of the study.\n10. Be adequately informed and understand the nature and risks of the study and be able to provide consent .\n\nExclusion Criteria:\n\n1. Has a known allergy to collagenase or any other excipient of EN3835 or any other procedural medication (including local anesthetics).\n2. Has received treatment for adhesive capsulitis (in the timeframes outlined below) or is planning to receive any treatment (other than study treatment) for adhesive capsulitis at any time during the study in the affected shoulder, including but not limited to:\n\n * Physical therapy or acupuncture within 2 weeks before the first injection of study treatment.\n * Intra-articular or intrabursal injection(s) of lidocaine, suprascapular nerve blocks, or electroanalgesic and/or thermoanalgesic modalities within 1 month before the Screening Visit.\n * Intra-articular or intrabursal injection(s) of corticosteroids within 8 weeks before the Screening Visit.\n * Intra-articular or intrabursal injection(s) of sodium hyaluronate and/or glenohumeral distension arthrography within 3 months before the Screening Visit.\n * Manipulation under anaesthesia at any time prior to the study.\n * Surgery (including arthroscopic or open capsular release, capsulectomy, or capsulotomy) at any time prior to the study.\n3. Has any abnormalities/conditions in the affected shoulder that would be potentially confounding as determined by the central MRI review committee grading criteria.\n4. Has a prosthesis or replacement of right or left shoulder, elbow, wrist, and/or hand.\n5. Has systemic conditions (malignancy, hypertension, diabetes, thyroid disease, thrombosis, physical impairment, infection, significant medical condition) that restricts study participation.\n6. Has any contraindications for MRI (implant containing metal, internal metallic object, permanent cosmetics/make-up/tattoos, claustrophobia, anemia, uncontrolled hypertension, epilepsy, asthma, sickle cell disease) as determined by the technologist, the radiologist, and/or investigator performing the imaging, with exemption of the area to be treated/reviewed.\n7. Has a known coagulation disorder or is taking any medications that would increase the risk of bleeding (except \\<150 milligrams of aspirin daily), 7 days prior to first injection and for the duration of the study.\n8. Has received oral or parenteral steroids for any reason within 3 weeks before the Screening Visit.\n9. Has, at any time, received collagenase for the treatment of adhesive capsulitis (including participant who received treatment in Study AUX-CC-870 or AUX-CC-871).\n10. Has received treatment with an investigational product within 30 days (or 5 half lives, whichever is longer) of the screening visit.\n11. Has received collagenase treatments (for example, Santyl® ointment and/or XIAFLEX/XIAPEX®) for any other indication within 30 days prior to study treatment administration, or is planning to be treated with collagenase (other than study treatment) at any time during the study.\n12. Has donated blood within 30 days prior to the Screening Visit or has plans to donate blood during the study.\n13. Has a corrected QT interval (QTc) of ≥ 450 milliseconds (ms) for male participant or ≥470 ms for female participant on the screening electrocardiogram (ECG).\n14. Is from a vulnerable population, as defined by the US Code of Federal Regulations (CFR) Title 45, Part 46, Section 46.111(b) and other local and national regulations, including but not limited to, employees (temporary, part-time, full-time, etc) or a family member of the research staff conducting the study, or of the sponsor, or of the contract research organization, or of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).\n15. Has concurrent diseases that might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the participant's well-being, (for example, evidence of any significant hematological, endocrine, cardiovascular, respiratory, neurological, renal, hepatic, or gastrointestinal disease). If there is a history of such disease but the condition has been stable for more than 5 year(s) and is judged by the investigator not to interfere with the participant's participation in the study, the participant may be included, with the documented approval of the Medical Monitor.\n16. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT04496167', 'briefTitle': 'Safety and Efficacy of EN3835 in Participants With Frozen Shoulder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Endo Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EN3835-210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EN3835', 'description': 'EN3835 up to 1.74 mg', 'interventionNames': ['Drug: EN3835']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EN3835', 'type': 'DRUG', 'description': 'Collagenase clostridium histolyticum', 'armGroupLabels': ['EN3835']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32505', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #38', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #24', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36609', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #9', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #29', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Endo Clinical Trial Site #12', 'geoPoint': {'lat': 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