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Clinical Trial Details

Trial ID:	L0845
Source ID:	NCT02065791
Associated Drug:	Canagliflozin
Title:	Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
Acronym:	CREDENCE
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT02065791/results
Conditions:	Diabetes Mellitus, Type 2\|Diabetic Nephropathy
Interventions:	DRUG: Canagliflozin\|DRUG: Placebo
Outcome Measures:	Primary: Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death, Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (\<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented., Up to 4.6 years \| Secondary: Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF), The composite endpoint included CV death and HHF. CV death included death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented., Up to 4.6 years\|Major Adverse Cardiac Event (MACE), The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented., Up to 4.6 years\|Hospitalized Heart Failure (HHF), Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of hospitalized heart failure are presented., Up to 4.6 years\|Renal Composite Endpoint, The renal composite endpoint included composite of DoSC, ESKD and Renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of \<15 mL/min/1.73 m\^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented., Up to 4.6 years\|Cardiovascular (CV) Death, CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented., Up to 4.6 years\|All-cause Mortality, Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented., Up to 4.6 years\|CV Composite Endpoint, The CV composite endpoint included the CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented., Up to 4.6 years
Sponsor/Collaborators:	Sponsor: Janssen Research & Development, LLC \| Collaborators: The George Institute for Global Health, Australia
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	4401
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date:	2014-02-17
Completion Date:	2018-10-30
Results First Posted:	2019-11-20
Last Update Posted:	2019-12-05
Locations:	Birmingham, Alabama, United States\|Montgomery, Alabama, United States\|Tempe, Arizona, United States\|Tucson, Arizona, United States\|Little Rock, Arkansas, United States\|Sherwood, Arkansas, United States\|Bakersfield, California, United States\|Chula Vista, California, United States\|Covina, California, United States\|Downey, California, United States\|Fountain Valley, California, United States\|Hawthorne, California, United States\|Inglewood, California, United States\|Laguna Hills, California, United States\|Lakewood, California, United States\|Long Beach, California, United States\|Los Angeles, California, United States\|Lynwood, California, United States\|Northridge, California, United States\|Oakland, California, United States\|Orange, California, United States\|Pasadena, California, United States\|Roseville, California, United States\|Sacramento, California, United States\|Salinas, California, United States\|San Diego, California, United States\|San Dimas, California, United States\|Stanford, California, United States\|Tustin, California, United States\|Whittier, California, United States\|Denver, Colorado, United States\|Golden, Colorado, United States\|Lakewood, Colorado, United States\|Washington, Colorado, United States\|Washington, District of Columbia, United States\|Coral Springs, Florida, United States\|Doral, Florida, United States\|Hialeah, Florida, United States\|Jacksonville, Florida, United States\|Miami Springs, Florida, United States\|Miami, Florida, United States\|North Miami Beach, Florida, United States\|Ocala, Florida, United States\|Port Charlotte, Florida, United States\|Saint Petersburg, Florida, United States\|Winter Park, Florida, United States\|Atlanta, Georgia, United States\|Augusta, Georgia, United States\|Columbus, Georgia, United States\|Roswell, Georgia, United States\|Snellville, Georgia, United States\|Stockbridge, Georgia, United States\|Chicago, Illinois, United States\|Crystal Lake, Illinois, United States\|Gurnee, Illinois, United States\|Mount Prospect, Illinois, United States\|Winfield, Illinois, United States\|Fort Wayne, Indiana, United States\|Indianapolis, Indiana, United States\|Merrillville, Indiana, United States\|Michigan City, Indiana, United States\|Muncie, Indiana, United States\|Council Bluffs, Iowa, United States\|Louisville, Kentucky, United States\|Paducah, Kentucky, United States\|Kenner, Louisiana, United States\|Rockport, Maine, United States\|Scarborough, Maine, United States\|Annapolis, Maryland, United States\|Baltimore, Maryland, United States\|Beltsville, Maryland, United States\|Hyattsville, Maryland, United States\|Silver Spring, Maryland, United States\|Boston, Massachusetts, United States\|Plymouth, Massachusetts, United States\|Springfield, Massachusetts, United States\|Worcester, Massachusetts, United States\|Flint, Michigan, United States\|Jackson, Mississippi, United States\|Chesterfield, Missouri, United States\|Kansas City, Missouri, United States\|Saint Louis, Missouri, United States\|Fremont, Nebraska, United States\|Lincoln, Nebraska, United States\|Omaha, Nebraska, United States\|Reno, Nebraska, United States\|Las Vegas, Nevada, United States\|Eatontown, New Jersey, United States\|Albuquerque, New Mexico, United States\|Albany, New York, United States\|Binghamton, New York, United States\|Buffalo, New York, United States\|Great Neck, New York, United States\|Lake Success, New York, United States\|New Hyde Park, New York, United States\|New York, New York, United States\|Ridgewood, New York, United States\|Riverhead, New York, United States\|Smithtown, New York, United States\|Springfield Gardens, New York, United States\|Asheville, North Carolina, United States\|Calabash, North Carolina, United States\|Charlotte, North Carolina, United States\|Durham, North Carolina, United States\|Greensboro, North Carolina, United States\|Greenville, North Carolina, United States\|High Point, North Carolina, United States\|Morehead City, North Carolina, United States\|Morganton, North Carolina, United States\|Raleigh, North Carolina, United States\|Tabor City, North Carolina, United States\|Whiteville, North Carolina, United States\|Cincinnati, Ohio, United States\|Columbus, Ohio, United States\|Maumee, Ohio, United States\|Roseburg, Oregon, United States\|Beaver, Pennsylvania, United States\|Bethlehem, Pennsylvania, United States\|Philadelphia, Pennsylvania, United States\|Pittsburgh, Pennsylvania, United States\|Anderson, South Carolina, United States\|Columbia, South Carolina, United States\|Lancaster, South Carolina, United States\|Murrells Inlet, South Carolina, United States\|Orangeburg, South Carolina, United States\|Sumter, South Carolina, United States\|Chattanooga, Tennessee, United States\|Knoxville, Tennessee, United States\|Memphis, Tennessee, United States\|Arlington, Texas, United States\|Corpus Christi, Texas, United States\|Corsicana, Texas, United States\|Dallas, Texas, United States\|Edinburg, Texas, United States\|Fort Worth, Texas, United States\|Houston, Texas, United States\|Mesquite, Texas, United States\|San Antonio, Texas, United States\|Schertz, Texas, United States\|Sugar Land, Texas, United States\|Temple, Texas, United States\|Waco, Texas, United States\|Salt Lake City, Utah, United States\|Bennington, Vermont, United States\|Burlington, Vermont, United States\|Bluefield, Virginia, United States\|Mechanicsville, Virginia, United States\|Norfolk, Virginia, United States\|Suffolk, Virginia, United States\|Spokane, Washington, United States\|Huntington, West Virginia, United States\|Milwaukee, Wisconsin, United States\|Bahia Blanca, Argentina\|Buenos Aires, Argentina\|Ciudad Autonoma Buenos Aires, Argentina\|Cordoba, Argentina\|Corrientes, Argentina\|Córdoba, Argentina\|Godoy Cruz, Argentina\|Junin, Argentina\|La Plata Lpl Lpl, Argentina\|La Plata, Argentina\|Mar del Plata, Argentina\|Mendoza, Argentina\|Moron, Argentina\|Munro, Argentina\|Parana, Argentina\|Quilmes, Argentina\|Ramos Mejia, Argentina\|Rosario, Argentina\|Salta, Argentina\|San Luis, Argentina\|San Martin, Argentina\|San Migeul De Tucuman, Argentina\|San Miguel de Tucuman, Argentina\|San Nicolas, Argentina\|Santa Fe, Argentina\|Sarandi, Argentina\|Tapiales, Argentina\|Temperley, Argentina\|Villa Maria, Argentina\|Zarate, Buenos Aires, Argentina\|Cairns, Australia\|Concord, Australia\|Darlinghurst, Australia\|Elizabeth Vale, Australia\|Fremantle, Australia\|Gosford, Australia\|Heidelberg, Australia\|Keswick, Australia\|Meadowbrook, Australia\|Parkville, Australia\|Reservoir, Australia\|Richmond, Australia\|St Albans, Australia\|St Leonards, Australia\|Sydney, Australia\|Woolloongabba, Australia\|Aparecida de Goiânia, Brazil\|Belo Horizonte, Brazil\|Belém, Brazil\|Botucatu, Brazil\|Brasilia, Brazil\|Campina Grande Do Sul, Brazil\|Campinas, Brazil\|Canoas, Brazil\|Caxias do Sul, Brazil\|Curitiba, Brazil\|Fortaleza, Brazil\|Joinville, Brazil\|Juiz de Fora, Brazil\|Maringá, Brazil\|Passo Fundo, Brazil\|Porto Alegre, Brazil\|Rio de Janeiro, Brazil\|Santo Andre, Brazil\|Santo André, Brazil\|Sao Jose Do Rio Preto, Brazil\|Sao Paulo, Brazil\|São José dos Campos, Brazil\|São Paulo, Brazil\|Tatuí, Brazil\|Blagoevgrad, Bulgaria\|Byala, Bulgaria\|Gulyantsi, Bulgaria\|Pazardzhik, Bulgaria\|Pleven, Bulgaria\|Plovdiv, Bulgaria\|Sofia, Bulgaria\|Varna, Bulgaria\|Edmonton, Alberta, Canada\|New Westminster, British Columbia, Canada\|Vancouver, British Columbia, Canada\|Winnipeg, Manitoba, Canada\|Brampton, Ontario, Canada\|London, Ontario, Canada\|NewMarket, Ontario, Canada\|Oshawa, Ontario, Canada\|Smiths Falls, Ontario, Canada\|Thornhill, Ontario, Canada\|Toronto, Ontario, Canada\|Weston, Ontario, Canada\|Greenfield Park, Quebec, Canada\|Montreal, Quebec, Canada\|Québec, Quebec, Canada\|Quebec, Canada\|Québec, Canada\|Toronto, Canada\|Vancouver, Canada\|Concepcion, Chile\|Santiago, Chile\|Temuco, Chile\|Beijing, China\|Changchun, China\|Changde, China\|Changsha, China\|Chengdu, China\|Chenzhou, China\|Dalian, China\|Foshan, China\|Guangzhou, China\|Huai'an, China\|Nanchang, China\|Nanjing, China\|Shanghai, China\|Shenyang, China\|Wuhan, China\|Wulumuqi, China\|Xian, China\|Barranquilla, Colombia\|Bogota, Colombia\|Bucaramanga, Colombia\|Cali, Colombia\|Floridablanca, Colombia\|Manizales, Colombia\|Medellin, Colombia\|Pasto, Colombia\|Pereira, Colombia\|Ceske Budejovice, Czechia\|Cesky Krumlov, Czechia\|Chocen, Czechia\|Havlickuv Brod, Czechia\|Hradec Kralove-Vekose, Czechia\|Hradec Nad Svitavou, Czechia\|Jindrichuv Hradec, Czechia\|Olomouc, Czechia\|Praha 10, Czechia\|Praha 2, Czechia\|Praha 4, Czechia\|Praha 5, Czechia\|Praha, Czechia\|Slany, Czechia\|Trutnov, Czechia\|Uherske Hradiste, Czechia\|Usti Nad Labem, Czechia\|Besancon Cedex, France\|Brest cedex, France\|Colmar N/a, France\|Corbeil Essonnes Cedex, France\|Créteil Cedex, France\|Grenoble, France\|Lyon cedex 03, France\|Marseille Cedex 05, France\|Metz cedex 03, France\|Nantes Cedex 01, France\|Paris Cedex 15, France\|Paris Cedex 18, France\|Paris, France\|Pierre-Bénit, France\|Poitiers, France\|St Priest-en-Jarez, France\|Strasbourg, France\|Toulouse Cedex 9, France\|Bad Kreuznach - Bosenheim, Germany\|Dietzenbach, Germany\|Dresden, Germany\|Essen, Germany\|Hamburg, Germany\|Hannover, Germany\|Köln, Germany\|Muenster, Germany\|Guatemala City, Guatemala\|Guatemala, Guatemala\|Baja, Hungary\|Balatonfured, Hungary\|Budapest, Hungary\|Debrecen, Hungary\|Eger, Hungary\|Esztergom, Hungary\|Godollo, Hungary\|Gyula, Hungary\|Hu-4012 Debrecen N/a, Hungary\|Kaposvar, Hungary\|Kecskemet N/a, Hungary\|Komarom, Hungary\|Nyiregyhaza, Hungary\|Pecs, Hungary\|Szeged N/a, Hungary\|Szigetvar, Hungary\|Veszprem, Hungary\|Zalaegerszeg, Hungary\|Calicut, India\|Chennai, India\|Delhi, India\|Hyderabad, India\|Kozhikode, India\|Lucknow, India\|Ludhiyana, India\|Mangalore, India\|Mumbai, India\|Mysore, India\|Secunderabad, India\|Trivandrum, India\|Vijayawada, India\|Vishakhapatnam, India\|Ageo-shi, Japan\|Chiyoda-ku, Japan\|Fukuoka, Japan\|Hamamatsu-shi, Japan\|Hamura-shi, Japan\|Ina-shi, Japan\|Izumisano, Japan\|Kamakura-shi, Japan\|Kanazawa, Japan\|Kawanishi-shi, Japan\|Koriyama-shi, Japan\|Kuki-shi, Japan\|Kyoto, Japan\|Matsuyama-shi, Japan\|Midori-shi, Japan\|Minato-ku, Japan\|Nagoya-shi, Japan\|Osaka-shi, Japan\|Ota-shi, Japan\|Saiki-shi, Japan\|Sashima-gun, Japan\|Shinjuku-ku, Japan\|Toyama-shi, Japan\|Uwajima-shi, Japan\|Yamanashi, Japan\|Yokohama-City, Japan\|Yokohama-shi, Japan\|Busan, Korea, Republic of\|Daegu, Korea, Republic of\|Incheon, Korea, Republic of\|Seongnam, Korea, Republic of\|Seoul, Korea, Republic of\|Kaunas, Lithuania\|Klaipeda, Lithuania\|Siauliai, Lithuania\|Batu Caves, Malaysia\|Ipoh, Malaysia\|Johor, Malaysia\|Kuala Lumpur N/a, Malaysia\|Kuala Lumpur, Malaysia\|Kuantan, Malaysia\|Melaka, Malaysia\|Perai, Malaysia\|Petaling Jaya, Malaysia\|Seremban, Malaysia\|Seri Manjung, Malaysia\|Sungai Petani, Kedah, Malaysia\|Tampin, Malaysia\|Temerloh, Malaysia\|Aguascalientes, Mexico\|Celaya, Mexico\|Chihuahua, Mexico\|Ciudad De Mexico, Mexico\|Ciudad De Mexic, Mexico\|Cuautitlan Izcalli, Mexico\|Culiacan, Mexico\|Culiacán, Mexico\|Durango, Mexico\|El Salto, Mexico\|Guadalajara, Mexico\|Leon, Mexico\|Merida, Mexico\|Mexico City, Mexico\|Mexico, Mexico\|Monterrey, Mexico\|Morelia, Mexico\|Orizaba, Mexico\|Pachuca de Soto, Mexico\|Pachuca, Mexico\|Queretaro, Mexico\|San Luis Potosi, Mexico\|Tlalnepantla de Baz, Mexico\|Veracruz, Mexico\|Zapopan, Mexico\|Auckland, New Zealand\|Christchurch, New Zealand\|Dunedin, New Zealand\|Palmerston North, New Zealand\|Rotorua, New Zealand\|Takapuna Auckland, New Zealand\|Tauranga, New Zealand\|Wellington, New Zealand\|Cagayan De Oro City, Philippines\|Cebuu City, Philippines\|Cebu, Philippines\|Davao City, Philippines\|Iloilo City, Philippines\|Lipa City, Philippines\|Marikina City, Philippines\|Pasay City, Philippines\|Pasig, Philippines\|Quezon City, Philippines\|San Fernando, Philippines\|Tagbilaran City, Philippines\|Taytay, Philippines\|Bydgoszcz, Poland\|Chorzow, Poland\|Katowice, Poland\|Krakow, Poland\|Lodz, Poland\|Lublin, Poland\|Parczew, Poland\|Poznan, Poland\|Radom, Poland\|Rzeszow, Poland\|Torun, Poland\|Warswa, Poland\|Wroclaw, Poland\|Zgierz, Poland\|Znin, Poland\|Caguas, Puerto Rico\|Ponce, Puerto Rico\|San Juan, Puerto Rico\|Brasov, Romania\|Bucuresti, Romania\|Cluj Napoca, Romania\|Deva, Romania\|Iasi, Romania\|Oradea, Romania\|Ploiesti, Romania\|Targu Mures, Romania\|Timisoara, Romania\|Arkhangelsk, Russian Federation\|Barnaul, Russian Federation\|Ivanovo, Russian Federation\|Kemerovo, Russian Federation\|Moscow, Russian Federation\|Novosibirsk, Russian Federation\|Petrozavodsk, Russian Federation\|Rostov-on-Don, Russian Federation\|Ryazan, Russian Federation\|Saint Petersburg, Russian Federation\|Saint-Petersburg, Russian Federation\|Saratov, Russian Federation\|Sestroretsk, Saint-Petersburg, Russian Federation\|St. Petersburg, Russian Federation\|Tomsk, Russian Federation\|Ufa, Russian Federation\|Volgograd, Russian Federation\|Yaroslavl, Russian Federation\|Belgrade, Serbia\|Nis, Serbia\|Zajecar, Serbia\|Bardejov, Slovakia\|Bratislava, Slovakia\|Kosice, Slovakia\|Lubochna, Slovakia\|Nitra, Slovakia\|Prievidza, Slovakia\|Puchov, Slovakia\|Rimavska Sobota, Slovakia\|Sturovo, Slovakia\|Svidnik, Slovakia\|Zilina, Slovakia\|Cape Town, South Africa\|Durban, South Africa\|Isipingo Rail, South Africa\|Johannesburg, South Africa\|Krugersdorp, South Africa\|Port Elizabeth, South Africa\|Pretoria Gauteng, South Africa\|Pretoria, South Africa\|Soweto, South Africa\|A Coruna, Spain\|Almeria, Spain\|Barcelona, Spain\|Burela, Spain\|Ciudad Real, Spain\|Getafe, Spain\|Girona, Spain\|Granada, Spain\|La Roca del Vallès, Spain\|Madrid, Spain\|Majadahonda, Spain\|Málaga, Spain\|Palma de Mallorca, Spain\|Pozuelo de Alarcón, Spain\|Sagunto, Spain\|Santander, Spain\|Sevilla, Spain\|Valencia, Spain\|Vic, Spain\|Viladecans, Spain\|Kaohsiung, Taiwan\|New Taipei City, Taiwan\|Taichung, Taiwan\|Taipei, Taiwan\|Chernivtsi, Ukraine\|Dnipropetrovsk, Ukraine\|Ivano-Frankivsk, Ukraine\|Kharkiv, Ukraine\|Kiev, Ukraine\|Kyiv, Ukraine\|Ternopil, Ukraine\|Vinnitsya, Ukraine\|Vinnytsia, Ukraine\|Zaporizhzhia, Ukraine\|Ajman, United Arab Emirates\|Dubai, United Arab Emirates\|Sharjah, United Arab Emirates\|Aberdeen, United Kingdom\|Antrim, United Kingdom\|Barry, United Kingdom\|Birmingham, United Kingdom\|Blackburn, United Kingdom\|Bolton, United Kingdom\|Bournemouth, United Kingdom\|Bradford, United Kingdom\|Bristol, United Kingdom\|Burbage, United Kingdom\|Cardff, United Kingdom\|Cardiff, United Kingdom\|Carlshalton, United Kingdom\|Carmarthen, United Kingdom\|Chester, United Kingdom\|Darlington, United Kingdom\|Doncaster, United Kingdom\|Durham, United Kingdom\|Ely, United Kingdom\|Hampstead, United Kingdom\|Harlow, United Kingdom\|Huntingdon, United Kingdom\|Leamington Spa, United Kingdom\|Liskeard, United Kingdom\|London, United Kingdom\|Middlesbrough, United Kingdom\|Plymouth, United Kingdom\|Rhyl, United Kingdom\|Rugby, United Kingdom\|Salford, United Kingdom\|Stoke On Trent, United Kingdom\|Swansea, United Kingdom\|Torpoint, United Kingdom\|Watford, United Kingdom\|Welwyn Garden City, United Kingdom\|Westcliff on Sea, United Kingdom\|Wokingham, United Kingdom\|Wolverhampton, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT02065791

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Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

Summary

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Associated Data

Associated NAFLD Drugs (0)