Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
NCT ID: NCT05586971
Last Updated: 2025-07-22
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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COMPLETED
PHASE3
2202 participants
INTERVENTIONAL
2023-03-30
2025-05-06
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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Tigulixostat 100mg
Tigulixostat 100mg, Once a day (QD) for up to 12 months
Tigulixostat
Xanthine Oxidase Inhibitor
Tigulixostat 200mg
Tigulixostat 200mg, Once a day (QD) for up to 12 months
Tigulixostat
Xanthine Oxidase Inhibitor
Tigulixostat 300mg
Tigulixostat 300mg (100mg + 200mg), Once a day (QD) for up to 12 months
Tigulixostat
Xanthine Oxidase Inhibitor
Titrated allopurinol (100-800mg)
Allopurinol 100-800mg, three times a day (TID) for up to 12 months. The allopurinol dose will be increased in 100 mg increments up to 800mg.
Allopurinol
Xanthine Oxidase Inhibitor
Placebo
Placebo, three times a day (TID) for up to 6 months.
Placebo
Matching placebo
Interventions
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Tigulixostat
Xanthine Oxidase Inhibitor
Allopurinol
Xanthine Oxidase Inhibitor
Placebo
Matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
* Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
* Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).
Exclusion Criteria
* Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
* Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
* Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
* Subjects with a history of xanthinuria (elevated levels of xanthine in the urine).
18 Years
85 Years
ALL
No
Sponsors
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LG Chem
INDUSTRY
Responsible Party
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Principal Investigators
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Hyungjin Cho, MD
Role: STUDY_DIRECTOR
LG Chem
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Alliance for Multispecialty Research, LLC
Daphne, Alabama, United States
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
Syed Research Consultants, LLC
Muscle Shoals, Alabama, United States
Syed Research Consultants, LLC
Sheffield, Alabama, United States
Arizona Research Clinic, PLLC
Chandler, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Flagstaff, Arizona, United States
Arizona Arthritis and Rheumatology Research PLLC
Glendale, Arizona, United States
Arizon Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States
Desert Clinical Research/CCT Research
Mesa, Arizona, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Velocity Clinical Research
Banning, California, United States
American Clinical Trials
Buena Park, California, United States
Shreenath Clinical Service
Lakewood, California, United States
Rancho Cucamonga Clinical Research
Rancho Cucamonga, California, United States
TriWest Research Associates
San Diego, California, United States
Rheumatology Center of San Diego
San Diego, California, United States
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, United States
Herco Medical and Research Center, Inc
Coral Gables, Florida, United States
Nouvelle Clinical Research LLC
Cutler Bay, Florida, United States
Omega Research Debary, LLC
DeBary, Florida, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Best Quality Research, Inc
Hialeah, Florida, United States
New Generation Of Medical Research, LLC
Hialeah, Florida, United States
Vital Pharma Research
Hialeah, Florida, United States
Accel Research Sites - Lakeland
Lake Mary, Florida, United States
Accel Research Sites - St. Petersburg- Largo
Lake Mary, Florida, United States
ARS-Matiland Clinical Research Unit
Lake Mary, Florida, United States
Homestead Associates in Research,Inc
Miami, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
D&H National Research Centers, Inc.
Miami, Florida, United States
Ivetmar Medical Group, LLC
Miami, Florida, United States
Care Research Center Inc
Miami, Florida, United States
Pharmax Research of South Florida, Inc
Miami, Florida, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Miami, Florida, United States
M&A Medical Centers and Research
Miami, Florida, United States
HMD Research LLC
Orlando, Florida, United States
IMA Clinical Research
St. Petersburg, Florida, United States
Adult Medicine of Lake County, Inc.
Tampa, Florida, United States
Research Institute of South Florida, Inc.
Tampa, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Clinical Research Trials of Florida, Inc.
Tampa, Florida, United States
Nodal Medical Center
Tampa, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
Clinical Site Partners LLC dba CSP Orlando
Winter Park, Florida, United States
Conquest Research
Winter Park, Florida, United States
Centricity Research
Columbus, Georgia, United States
Arthritis Center of North Georgia
Gainesville, Georgia, United States
Vista Clinical Research, LLC
Newnan, Georgia, United States
East West Medical Research Institute
Honolulu, Hawaii, United States
Family Care Research, LLC
Boise, Idaho, United States
Alliance for Multispecialty Research, LLC
Meridian, Idaho, United States
IMA Research, Inc.
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
American Health Network of Indiana, LLC
Franklin, Indiana, United States
American Health Network of Indiana LLC
Muncie, Indiana, United States
Integrated Clinical Trial Services Inc.
West Des Moines, Iowa, United States
Women's & Family Care LLC, dba GTC Research
Shawnee Mission, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, United States
Versailles Family Medicine
Versailles, Kentucky, United States
Clinical Trials Management, LLC
Covington, Louisiana, United States
Clinical Trials Management
Metairie, Louisiana, United States
MD Medical Research
Oxon Hill, Maryland, United States
Elite Clinical Research, LLC
Jackson, Mississippi, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Practice Dr David Headley
Port Gibson, Mississippi, United States
Healthcare Research Network
Hazelwood, Missouri, United States
Alliance for Multispecialty Research, LLC
Kansas City, Missouri, United States
Clay-Platte Family Medicine Clinic
Kansas City, Missouri, United States
IMA Clinical Research
St Louis, Missouri, United States
St. Louis Medical Professionals, LLC
St Louis, Missouri, United States
Montana Medical Research, Inc.
Missoula, Montana, United States
Methodist Physicians Clinic/CCT Research
Fremont, Nebraska, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Healor Primary Care /CCT Research
Las Vegas, Nevada, United States
Wake Research - CRCN
Las Vegas, Nevada, United States
Alliance for Multispecialty Research, LLC.
Las Vegas, Nevada, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, United States
Inspire Santa Fe Medical Group
Santa Fe, New Mexico, United States
Long Island Regional Arthritis & Osteoporosis Care PC
Babylon, New York, United States
IMA Clinical Research
New York, New York, United States
Conquest Research
Vestal, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Triad Clinical Trials, LLC
Greensboro, North Carolina, United States
Olympus Family Medicine
Hendersonville, North Carolina, United States
Burke Primary Care
Morganton, North Carolina, United States
Carolina Research Center, Inc.
Shelby, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Trinity Health Center Medical Arts
Minot, North Dakota, United States
Arthritis Associates of Northwest Ohio Inc.
Perrysburg, Ohio, United States
STAT Research
Vandalia, Ohio, United States
Hatboro Medical Associates, P.C.
Hatboro, Pennsylvania, United States
Tristar Clinical Investigations, P.C.
Philadelphia, Pennsylvania, United States
New Phase Research
Knoxville, Tennessee, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Inquest Clinical Research
Baytown, Texas, United States
PCCR Solutions
Colleyville, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
DFW Clinical Research
Dallas, Texas, United States
Dallas Fort Worth Clinical Research Associates
Fort Worth, Texas, United States
Pioneer Research Solutions, Inc.
Houston, Texas, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
AIM Trials, LLC
Plano, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Sugar Lakes Family Practice, PA
Sugar Land, Texas, United States
DM Clinical Research
Tomball, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Cope Family Medicine/CCT Research
Bountiful, Utah, United States
Olympus Family Medicine
Salt Lake City, Utah, United States
Highland Clinical Research
Salt Lake City, Utah, United States
South Ogden Family Medicine Clinic
South Ogden, Utah, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Meridian Clinical Research, LLC
Portsmouth, Virginia, United States
Dominion Medical Associates, Inc.
Richmond, Virginia, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
Hospital Universitario Austral
Buenos Aires, , Argentina
Instituto de Investigaciones Clinicas San Nicolás
Buenos Aires, , Argentina
Centro Médico Reumatologico - Organizacion Medica de Investigacion S.A. (OMI)
Buenos Aires, , Argentina
Aprillus Asistencia e Investigacion Clinica
Buenos Aires, , Argentina
Centro Privado de Medicina Familiar
Buenos Aires, , Argentina
Clinica Adventista Belgrano
Buenos Aires, , Argentina
Instituto de Investigaciones Clinicas Cordoba
Córdoba, , Argentina
Centro Integral De Dianogostico por Imagenes Marchegiani (CIDIM)
Córdoba, , Argentina
Instituto Reumatologico Strusberg
Córdoba, , Argentina
Clinica Privada Velez Sarsfield (CPVS)
Córdoba, , Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucumán, , Argentina
Instituto CAICI (Instituto Centralizado de Asistencia e Investigacion Clinica Integral)
Santa Fe, , Argentina
Emeritus Research (Melbourne)
Camberwell, , Australia
Holdsworth House Medical Practice
Darlinghurst, , Australia
Griffith University Clinical Trial Unit
Southport, , Australia
Emeritus Research (Sydney)
Sydney, , Australia
The Queen Elizabeth Hospital
Woodville South, , Australia
ReumaClinic
Genk, , Belgium
CHU de Liège
Liège, , Belgium
CHU HELORA - Hôpital de Mons - Site Kenedy
Mons, , Belgium
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, , Brazil
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, , Brazil
EDUMED - Educação em Saúde S/S Ltda
Curitiba, , Brazil
LMK Serviços Médicos Sociedade Simples
Curitiba, , Brazil
CMIP-Centro Mineiro de Pesquisa
Juiz de Fora, , Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, , Brazil
SER - Serviços Especializados em Reumatologia da Bahia
Salvador, , Brazil
Clinica Medica Bonfiflioli Ltda
São Paulo, , Brazil
University Multiprofile Hospital for Active Treatment Plovdiv "Eurohospital" Ltd
Plovdiv, , Bulgaria
Mbal Lyulin EAD
Sofia, , Bulgaria
Medical Center Excelsior OOD
Sofia, , Bulgaria
DCC Fokus-5 Lzip OOD
Sofia, , Bulgaria
Medical Center-N.I. Pirogov EOOD
Sofia, , Bulgaria
Military medical academy
Sofia, , Bulgaria
Acibadem City Clinic Diagnostic And Consultation Center Ltd
Sofia, , Bulgaria
Medical Center Synexus Sofia EOOD
Sofia, , Bulgaria
Centro de Investigacion en Reumatología y Especialidades Médicas S.A.S (CIREEM S.A.S)
Bogotá, , Colombia
Servimed S.A.S.
Bucaramanga, , Colombia
IPS Medicos Internistas de Caldas SAS
Manizales, , Colombia
Healthy Medical Center SAS
Zipaquirá, , Colombia
MUDr. Michaela Blahova, revmatologicka ambulance s.r.o.
Brno, , Czechia
REVMACLINIC s.r.o.
Brno, , Czechia
L.K.N Arthrocentrum
Hlučín, , Czechia
Revmatologicky ustav
New Town, , Czechia
MEDICAL PLUS s.r.o.
Uherské Hradiště, , Czechia
CHU De Bordeaux
Bordeaux, , France
Hôpital Saint Philibert
Lomme, , France
Hôpital Edourad Herriot
Lyon, , France
Hôpital Lapeyronie
Montpellier, , France
Centre Hospitalier Regional D'Orleans
Orléans, , France
CHU Hôpitaux De Rouen
Rouen, , France
"LJ Clinic" LTD
Kutaisi, , Georgia
Aleksandre Aladashvili Clinic LLC
Tbilisi, , Georgia
LTD "Israeli-Georgian Medical Research Clinic Helsicore"
Tbilisi, , Georgia
Cardioclinic - Digomi Medical Center
Tbilisi, , Georgia
JSC "Evex Hospitals"
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, , Georgia
LTD MediClub Georgia
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medula LTD
Tbilisi, , Georgia
Emovis GmbH
Berlin, , Germany
Gemeinschaftspraxis Dres. T. und N. Jung
Deggingen, , Germany
Klinische Forschung Dresden GmbH
Dresden, , Germany
Medizentrum Essen Borbeck
Essen, , Germany
Velocity Clincial Research Hamburg GmbH
Hamburg, , Germany
Praxis für klinische Studien
Hamburg, , Germany
Klinische Forschung Karlsruhe GmbH
Karlsruhe, , Germany
Klinische Forschung Schwerin GmbH
Schwerin, , Germany
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
Alessandria, , Italy
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, , Italy
AOU Policlinico Paolo Giaccone
Palermo, , Italy
AUSL di Reggio Emilia, Arcispedale Santa Maria Nuova-IRCCS
Reggio Emilia, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, , Lithuania
Kaunas City Polyclinic, Dainava Outpatient Clinic
Kaunas, , Lithuania
Klaipeda University Hospital
Klaipėda, , Lithuania
Hospital Selayang
Batu Caves, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Klinik Kesihatan Kuang Lumpur
Kuala Lumpur, , Malaysia
Hospital Umum Sarawak
Kuching, , Malaysia
Klinik Kesihatan Masjid Tanah
Masjid Tanah, , Malaysia
Hospital Miri
Miri, , Malaysia
Klinik Kesihatan Kuang
Rawang, , Malaysia
Hospital Seri Manjung
Seri Manjung, , Malaysia
Southern Clinical Trials Totara
Auckland, , New Zealand
PCRN Silverdale Medical Centre
Auckland, , New Zealand
Aotearoa Clinical Trials
Auckland, , New Zealand
Pacific Clinical Research Network (PCRN) Clinical Trials
Christchurch, , New Zealand
Lakeland Clinical Trials Waikato
Hamilton, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Southern Clinical Trials Tasman
Nelson, , New Zealand
Pacific Clinical Research Network (PCRN) - Rotorua
Rotorua, , New Zealand
Lakeland Clinical Trials Wellington
Wellington, , New Zealand
Wellington Regional Hospital
Wellington, , New Zealand
Angeles University Foundation Medical Center
Angeles, , Philippines
Baguio General Hospital and Medical Center
Baguio City, , Philippines
Cebu Doctors' University Hospital
Cebu, , Philippines
De la Salle Medical and Health Sciences Institute
Dasmariñas, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
Iloilo Doctors' Hospital Inc
Iloilo City, , Philippines
St. Paul's Hospital of Iloilo
Iloilo City, , Philippines
Lipa Medix Medical Center
Lipa, , Philippines
Ospital ng Makati
Makati, , Philippines
Makati Medical Center
Makati, , Philippines
Manila Doctors Hospital
Manila, , Philippines
Medical Center Manila
Manila, , Philippines
University of the Philippines - Philippine General Hospital
Manila, , Philippines
Chinese General Hospital and Medical Center
Manila, , Philippines
ClinicMed Daniluk, Nowak Spdtka komandytowa
Bialystok, , Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Malopolskie Centrum Kliniczne
Krakow, , Poland
Pratia MCM Krakow
Krakow, , Poland
Centrum Medyczne PROMED
Krakow, , Poland
SOMED CR
Lodz, , Poland
Zespol Poradni Specjalistycznych REUMED, Filia nr 1 Wallenroda
Lublin, , Poland
ETYKA - Ośrodek Badań Klinicznych
Olsztyn, , Poland
FutureMeds Warszawa Centrum
Warsaw, , Poland
MICS Centrum Medyczne Warszawa
Warsaw, , Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, , Poland
FutureMeds Targéwek
Warsaw, , Poland
Reum-Medica S.C. Bozena Kowalewska, Marek Zawadzki
Wroclaw, , Poland
Pusan National University Hospital
Busan, , South Korea
Keimyung University Dongsan hospital
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Kyunghee University Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Uijeongbu Eulji Medical Cen
Uijeongbu-si, , South Korea
Hospital Universitario de A Coruña
A Coruña, , Spain
HM Hospital Nuestra Señora de la Esperanza
A Coruña, , Spain
Hospital Clinico Universitario de Santiago de Compostela (CHUS)
A Coruña, , Spain
Hospital Sanitas CIMA
Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital de Bellvitge
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Clinica Gaias Santiago
Santiago de Compostela, , Spain
Hospital Quirónsalud Sagrado Corazón
Seville, , Spain
Hospital do Meixoeiro
Vigo, , Spain
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
Chang Gung Medical Foundation - Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Phramongkutklao Hospital
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Ramathibodi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Thammasat University Hospital
Khlong Luang, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Countries
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References
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Saag KG, Dalbeth N, Hsu CY, Kuo CF, Nuki G, Perez-Ruiz F, White WB, Hariri A, Lee Y, Jang Y, Han S, Choi HK. Evaluation of the efficacy and safety of a novel xanthine oxidase inhibitor, tigulixostat, in gout patients with hyperuricemia: Design of the EURELIA 1 and EURELIA 2 studies. Contemp Clin Trials. 2025 Apr;151:107843. doi: 10.1016/j.cct.2025.107843. Epub 2025 Feb 8.
Other Identifiers
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LG-GDCL010
Identifier Type: -
Identifier Source: org_study_id
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