Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
284 participants
INTERVENTIONAL
2023-01-02
2027-04-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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High Dose GSK4532990
GSK4532990
GSK4532990 will be administered.
Low Dose GSK4532990
GSK4532990
GSK4532990 will be administered.
Placebo
Placebo
Placebo will be administered.
Interventions
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GSK4532990
GSK4532990 will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
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Inclusion Criteria
* In the opinion of the investigator, there are features of metabolic syndrome and NAFLD is the most likely cause of liver disease. Metabolic syndrome may include type 2 diabetes mellitus (T2DM), obesity, dyslipidemia and hypertension.
* A liver biopsy at baseline showing NAFLD Activity Score (NAS) \>=4 with at least 1 point each in steatosis, inflammation and ballooning and either Fibrosis 3 or Fibrosis 4 using NASH CRN Scoring System.
* Able and willing to comply with all study assessments, including a liver biopsy at Week 52.
Exclusion Criteria
* Weight reduction surgery or procedures (including gastric banding and intragastric balloon insertion) within 2 years of Screening 1 and/or planned during the study.
* History of cancer within previous 2 years from Screening 1, except basal or squamous cell carcinoma of the skin or in situ cervical carcinoma or any other type of cancer which has been treated medically or surgically with curative outcome.
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Homewood, Alabama, United States
GSK Investigational Site
Chandler, Arizona, United States
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Chandler, Arizona, United States
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Mesa, Arizona, United States
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Jonesboro, Arkansas, United States
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North Little Rock, Arkansas, United States
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Huntington Park, California, United States
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La Jolla, California, United States
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Orange, California, United States
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Poway, California, United States
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Rialto, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Van Nuys, California, United States
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Colorado Springs, Colorado, United States
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Bradenton, Florida, United States
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Coral Gables, Florida, United States
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Fort Myers, Florida, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Jupiter, Florida, United States
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Lakewood Rch, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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West Palm Beach, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Snellville, Georgia, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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Iowa City, Iowa, United States
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Topeka, Kansas, United States
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Bastrop, Louisiana, United States
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Marrero, Louisiana, United States
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Marrero, Louisiana, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Columbia, Maryland, United States
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Greenbelt, Maryland, United States
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Ann Arbor, Michigan, United States
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Southfield, Michigan, United States
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Ypsilanti, Michigan, United States
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Chesterfield, Missouri, United States
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Las Vegas, Nevada, United States
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Princeton, New Jersey, United States
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Sparta, New Jersey, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, United States
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Springboro, Ohio, United States
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Westlake, Ohio, United States
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Lancaster, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Clarksville, Tennessee, United States
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Austin, Texas, United States
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Brownsville, Texas, United States
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Dallas, Texas, United States
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Edinburg, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Waco, Texas, United States
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West Jordan, Utah, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Buenos Aires, , Argentina
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Capital Federal, , Argentina
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Ciudad AutOnoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Bueno, , Argentina
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Pilar, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Calgary, Alberta, Canada
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Toronto, Ontario, Canada
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Angers, , France
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Limoges, , France
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Paris, , France
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Pierre-Bénite, , France
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Strasbourg, , France
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Athens, , Greece
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Rio Patras, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Bhubaneswar, , India
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Chandigarh, , India
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Coimbatore, , India
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Guhawati, , India
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Mumbai, , India
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Nagpur, , India
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New Delhi, , India
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Secunderabad, , India
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Surat, , India
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Florence, , Italy
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Milan, , Italy
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Modena, , Italy
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Padua, , Italy
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Palermo, , Italy
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Roma, , Italy
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Rozzano MI, , Italy
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San Giovanni Rotondo FG, , Italy
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Fukui, , Japan
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Fukuoka, , Japan
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Gifu, , Japan
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Gifu, , Japan
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Gifu, , Japan
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Gifu, , Japan
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Hiroshima, , Japan
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Kagawa, , Japan
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Kagawa, , Japan
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Kagawa, , Japan
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Kagoshima, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Kanagawa, , Japan
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Nagano, , Japan
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Nagasaki, , Japan
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Nara, , Japan
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Numakunai, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Saga, , Japan
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Shimane, , Japan
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Yamanashi, , Japan
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Cuernavaca Morelos, , Mexico
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Guadalajara, , Mexico
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Mérida, , Mexico
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Panama City, , Panama
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Panama City, , Panama
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San Juan, , Puerto Rico
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Yongsan-Ku Seoul, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Sabadell Barcelona, , Spain
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Santander, , Spain
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Seville, , Spain
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Vigo, , Spain
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Ankara, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Rize, , Turkey (Türkiye)
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Cannock, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Nottingham, , United Kingdom
Countries
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Other Identifiers
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2022-002538-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-507503-62-00
Identifier Type: OTHER
Identifier Source: secondary_id
218672
Identifier Type: -
Identifier Source: org_study_id
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