Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561806', 'term': 'lebrikizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% Reduction from Baseline in EASI), or a ≥4-point Reduction in Pruritus Numerical Rating Scale (NRS) from Baseline', 'timeFrame': 'Week 16', 'description': 'The primary endpoint will be a composite endpoint as defined by achieving either EASI-75 or Pruritus NRS≥4-point Reduction from Baseline.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving EASI-75', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Percentage of Participants Achieving a ≥4-point Reduction from Baseline in Pruritus NRS', 'timeFrame': 'Baseline to Week 24'}, {'measure': "Percentage of Participants with an Investigator's Global Assessment (IGA) of 0 or 1 and a Reduction ≥2 points from Baseline", 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Percentage of Participants Achieving EASI-90', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Change from Baseline in Body Surface Area (BSA) Involvement', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Percentage of Change from Baseline in Pruritus NRS Score', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Percentage of Participants with a Sleep-loss Scale Score of ≥2 points at Baseline Who Achieve a ≥ 2-point Reduction', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Percentage Change from Baseline in Sleep-loss Scale', 'timeFrame': 'Baseline, Week 24'}, {'measure': 'Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction', 'timeFrame': 'Baseline to Week 24'}, {'measure': 'Change from Baseline in Dermatology Quality of Life (DLQI)', 'timeFrame': 'Baseline, Week 24'}, {'measure': "Change from Baseline in Children's Dermatology Quality of Life (CDLQI)", 'timeFrame': 'Baseline, Week 24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy.\n\nParticipation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening visit.\n* Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline.\n* Have pruritus numeric rating scale (NRS) ≥6 at baseline.\n* Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.\n* Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) at screening and baseline.\n* Based on investigator judgement, have a history of inadequate response to treatment with topical medications, or determination that topical treatments are otherwise medically inadvisable.\n* For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) at baseline.\n\nExclusion Criteria:\n\n* Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator).\n* Have known liver cirrhosis and/or chronic hepatitis of any etiology.\n* History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.\n* Are diagnosed with active endoparasitic infections or at high risk of these infections.\n* Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per the investigator's judgment.\n* Have presence of skin comorbidities that may interfere with study assessments.\n* Have a severe concomitant illness(es) that in the investigator's judgment would adversely affect the participant's participation in the study.\n* Have had any of the following types of infection within 3 months of screening or develop any of these infections during screening:\n\n * Serious (requiring hospitalization, and/or intravenous or equivalent oral antibiotic treatment).\n * Opportunistic - Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.\n * Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).\n * Recurring (including, but not limited to, recurring cellulitis and chronic osteomyelitis).\n* Have an active or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit or superficial skin infections within 1 week before the baseline visit.\n* Have had any prior treatment with a biologic therapy for AD.\n* Have had treatment with any of the following agents within 4 weeks prior to the baseline visit:\n\n * systemic immunosuppressive or immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma,\n * azathioprine, methotrexate, and other immunosuppressants)\n * small molecules (for example, Janus kinase inhibitors \\[topical or systemic\\]), or\n * phototherapy and photochemotherapy for AD.\n* Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to baseline."}, 'identificationModule': {'nctId': 'NCT07006792', 'acronym': 'ADsolve', 'briefTitle': 'A Study to See How Well Lebrikizumab Works in Adults and Adolescents With Moderate Atopic Dermatitis (Eczema) and High Itch Burden', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden', 'orgStudyIdInfo': {'id': '27407'}, 'secondaryIdInfos': [{'id': 'J2T-MC-KGCE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lebrikizumab', 'description': 'Lebrikizumab administered subcutaneously (SC).', 'interventionNames': ['Drug: Lebrikizumab']}], 'interventions': [{'name': 'Lebrikizumab', 'type': 'DRUG', 'otherNames': ['LY3650150'], 'description': 'Administered SC', 'armGroupLabels': ['Lebrikizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35203', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '205-380-6148'}, {'name': 'James Krell', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology', 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Research Institute', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '714-531-2966'}, {'name': 'Vivian Laquer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First OC Dermatology Research Inc', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '310-337-7171'}, {'name': 'Howard Sofen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95765', 'city': 'Rocklin', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '916-524-1216'}, {'name': 'Raja Sivamani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NorCal Clinical Research', 'geoPoint': {'lat': 38.79073, 'lon': -121.23578}}, {'zip': '33172', 'city': 'Doral', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '786-623-3135'}, {'name': 'Lucy Martin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Suncoast Research Associates', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '954-400-1725'}, {'name': 'Jerome Obed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Encore Medical Research', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '904-619-8157'}, {'name': 'Pearl Kwong', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Solutions Through Advanced Research', 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-80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '305-209-1268'}, {'name': 'Marta Delgado', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Deluxe Health Center', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34470', 'city': 'Ocala', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '352-629-5800'}, {'name': 'Ashley Cauthen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33317', 'city': 'Plantation', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '954-371-2208'}, {'name': 'Elyse Julian', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Leading Edge Dermatology', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '561-655-9055'}, {'name': 'Kenneth Beer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Research Institute of the Southeast', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30305', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '404-806-5291'}, {'name': 'Anita Shetty', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dermatology Affiliates Research Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60602', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'George Lewitt', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'DeNova Research', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '47201', 'city': 'Columbus', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '812-418-7493'}, {'name': 'Michael Sheehan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Indiana Clinical Research Center', 'geoPoint': {'lat': 39.20144, 'lon': -85.92138}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '317-516-5030'}, {'name': 'Scott Fretzin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '47150', 'city': 'New Albany', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '502-373-8133'}, {'name': 'Megan Landis', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Indiana Clinical Trials', 'geoPoint': {'lat': 38.28562, 'lon': -85.82413}}, {'zip': '42104', 'city': 'Bowling Green', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '270-213-7777'}, {'name': 'James Allred', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Equity Medical - Bowling Green', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'zip': '42301', 'city': 'Owensboro', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '270-684-6144'}, {'name': 'Lee Clore', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Allergy & Asthma Specialists, P.S.C.', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alison Ehrlich', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Foxhall Research Center', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '989-895-9100'}, {'name': 'Brent Boyce', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Great Lakes Research Group, Inc.', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '248-590-0298'}, {'name': 'Ali Moiin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Revival Research Institute, LLC', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '87102', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '505-224-7407'}, {'name': 'Satkirin Khalsa', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Albuquerque Clinical Trials, Inc.', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10023', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gerardo Russo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Equity Medical', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ahuva Cices', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28602', 'city': 'Hickory', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jake Turrentine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hickory Dermatology Research Center', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}, {'zip': '45324', 'city': 'Fairborn', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '937-245-7500'}, {'name': 'Craig Rohan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Wright State Physicians', 'geoPoint': {'lat': 39.82089, 'lon': -84.01938}}, {'zip': '37072', 'city': 'Goodlettsville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Keith Loven', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ObjectiveHealth - Goodlettsville Dermatology Research', 'geoPoint': {'lat': 36.32311, 'lon': -86.71333}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Asma Ahmed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Peter Smith Hospital', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '75033', 'city': 'Frisco', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '469-225-9920'}, {'name': 'Aaron Farberg', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Reveal Research Institute - Frisco', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '77084', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '281-944-3610'}, {'name': 'Uyen Mui, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Biopharma Informatic, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76063', 'city': 'Mansfield', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '817-907-7330'}, {'name': 'Jeannine Hoang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prime Clinical Research - Mansfield', 'geoPoint': {'lat': 32.56319, 'lon': -97.14168}}, {'zip': '78235', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '210-852-2779'}, {'name': 'John Browning', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Texas Dermatology and Laser Specialists - San Antonio - South New Braunfels Avenue', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84095', 'city': 'South Jordan', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Douglass Forsha', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jordan Valley Dermatology & Research Center', 'geoPoint': {'lat': 40.56217, 'lon': -111.92966}}, {'zip': '1012', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '5411-3989-9011'}, {'name': 'Pablo Gonzalez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CONEXA Investigacion Clinica S.A.', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1061', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': '541148756767'}, {'name': 'Mariano Marini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CIPREC', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1056ABI', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'role': 'CONTACT', 'phone': 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