A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
89bio, Inc.
1,350 participants
Mar 13, 2024
INTERVENTIONAL
Conditions
Summary
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
Eligibility
Inclusion Criteria3
- Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)
- Biopsy-confirmed MASH with fibrosis stage F2 or F3
- Body mass index (BMI) at screening ≥25.0 kilograms (kg)/meters squared (m\^2) (≥23 kg/m\^2 for Asian participants).
Exclusion Criteria5
- Chronic liver diseases other than MASH
- Evidence of cirrhosis on screening liver biopsy
- Have type 1 diabetes or poorly controlled type 2 diabetes
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U/L)
- Participants taking vitamin E (\>400 international units \[IU\]/day) or pioglitazone must be on stable dose for at least 6 months prior to Screening
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Interventions
Subcutaneous injection
Subcutaneous injection
Locations(331)
89bio Clinical Study Site
Birmingham, Alabama, United States
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Chandler, Arizona, United States
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Flagstaff, Arizona, United States
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Glendale, Arizona, United States
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Tucson, Arizona, United States
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Conway, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Canoga Park, California, United States
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Coronado, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Gardena, California, United States
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Huntington Park, California, United States
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Inglewood, California, United States
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La Jolla, California, United States
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Lancaster, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Montclair, California, United States
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Orange, California, United States
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Panorama City, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Rialto, California, United States
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Santa Ana, California, United States
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Stanford, California, United States
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Victorville, California, United States
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Colorado Springs, Colorado, United States
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Littleton, Colorado, United States
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Brandon, Florida, United States
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Clermont, Florida, United States
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Fort Myers, Florida, United States
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Hialeah Gardens, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Lady Lake, Florida, United States
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Lady Lake, Florida, United States
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Lakewood Rch, Florida, United States
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Maitland, Florida, United States
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Maitland, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Ocoee, Florida, United States
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Sarasota, Florida, United States
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Winter Park, Florida, United States
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Athens, Georgia, United States
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Dalton, Georgia, United States
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Hammond, Indiana, United States
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New Albany, 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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Covington, Louisiana, United States
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Houma, Louisiana, United States
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Marrero, Louisiana, United States
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New Orleans, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Glen Burnie, Maryland, United States
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Greenbelt, Maryland, United States
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Burlington, Massachusetts, United States
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Chesterfield, Michigan, United States
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Wyoming, Michigan, United States
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Ypsilanti, Michigan, United States
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Rochester, Minnesota, United States
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Flowood, Mississippi, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Florham Park, New Jersey, United States
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Freehold, New Jersey, United States
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Warren Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Carmel, 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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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Fayetteville, 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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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Liberty Township, Ohio, United States
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Springboro, Ohio, United States
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Westlake, Ohio, United States
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East Greenwich, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Chattanooga, Tennessee, United States
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Cordova, Tennessee, United States
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Hermitage, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Bellaire, Texas, United States
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Brownsville, Texas, United States
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Corpus Christi, Texas, United States
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DeSoto, Texas, United States
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Edinburg, Texas, United States
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Farmers Branch, Texas, United States
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Fort Sam Houston, Texas, United States
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Fort Worth, Texas, United States
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Garland, Texas, United States
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Georgetown, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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Katy, 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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San Antonio, 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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Stafford, Texas, United States
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Tomball, Texas, United States
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Waco, Texas, United States
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Waco, Texas, United States
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Ogden, Utah, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Caba, Argentina
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Capital Federal, Argentina
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Pilar, Argentina
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Brisbane, Queensland, Australia
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Herston, Queensland, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, South Australia, Australia
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Clayton, Victoria, Australia
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Heidelberg, Victoria, Australia
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Perth, Western Australia, Australia
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Fitzroy, Australia
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Graz, Austria
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Innsbruck, Austria
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Klagenfurt, Austria
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Sankt Pölten, Austria
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Wels, Austria
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Brussels, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Genk, Belgium
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Ghent, Belgium
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Jette, Belgium
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Gorna Oryahovitsa, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Vaughan, Ontario, Canada
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Brno, Czechia
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Ostrava, Czechia
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Pilsen, Czechia
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Amiens, France
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Angers, France
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Bordeaux, France
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Lille, France
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Limoges, France
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Lyon, France
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Montpellier, France
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Nantes, France
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Nice, France
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Paris, France
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Paris, France
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Paris, France
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Pierre-Bénite, France
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Strasbourg, France
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Toulouse, France
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Toulouse, France
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Vandœuvre-lès-Nancy, France
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Vénissieux, France
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Villejuif, France
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Batumi, Georgia
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Batumi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Chemnitz, Germany
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Frankfurt am Main, Germany
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Freiburg im Breisgau, Germany
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Hanover, Germany
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Homburg, Germany
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Münster, Germany
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Hong Kong, Hong Kong
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Shatin, Hong Kong
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Guwahati, Assam, India
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Kolkata, West Bengal, India
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Bhubaneswar, India
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Gujrāt, India
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Nagpur, India
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Wardha, India
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Afula, Israel
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Beersheba, Israel
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Haifa, Israel
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Haifa, Israel
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Jerusalem, Israel
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Nahariya, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Tel Aviv, Israel
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Bergamo, Italy
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Milan, Italy
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Milan, Italy
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Milan, Italy
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Modena, Italy
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Naples, Italy
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Novara, Italy
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Palermo, Italy
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Roma, Italy
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Rome, Italy
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Rome, Italy
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Torino, Italy
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Maebashi, Gunma, Japan
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Sapporo, Hokkaido, Japan
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Hizume, Iwate, Japan
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Kawasaki, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Ehime, Japan
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Ehime, Japan
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Fukuoka, Japan
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Gifu, Japan
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Kumamoto, Japan
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Nagano, Japan
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Okayama, Japan
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Osaka, Japan
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Osaka, Japan
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Saga, Japan
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Sapporo, Japan
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Chihuahua City, Mexico
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Cuautitlán Izcalli, Mexico
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Jalisco, Mexico
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Mexico City, Mexico
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Mexico City, Mexico
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Morelos, Mexico
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Nuevo León, Mexico
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Yucatán, Mexico
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Rotterdam, South Holland, Netherlands
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Amsterdam, Netherlands
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Utrecht, Netherlands
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Katowice, Poland
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Krakow, Poland
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Lodz, Poland
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Lodz, Poland
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Mysłowice, Poland
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Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Mayagüez, Puerto Rico
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San Juan, Puerto Rico
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Singapore, Singapore
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Singapore, Singapore
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Singapore, Singapore
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Singapore, Singapore
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Cape Town, South Africa
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Johannesburg, South Africa
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Worcester, South Africa
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Busan, South Korea
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Daegu, South Korea
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Gyeonggi-do, South Korea
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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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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Barcelona, Spain
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Córdoba, Spain
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Madrid, Spain
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Majadahonda, Spain
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Málaga, Spain
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Pontevedra, Spain
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Santander, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Chiayi City, Taiwan
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Kaohsiung City, Taiwan
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Taipei, Taiwan
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Adana, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Center, Turkey (Türkiye)
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Fatih, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Sarıçam, Turkey (Türkiye)
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Umraniye, Turkey (Türkiye)
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High Wycombe, Buckinghamshire, United Kingdom
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Bristol, United Kingdom
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Glasgow, United Kingdom
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Hull, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Oxford, United Kingdom
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Portsmouth, United Kingdom
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Preston, United Kingdom
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Southampton, United Kingdom
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Stockton, United Kingdom
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Sunderland, United Kingdom
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Swansea, United Kingdom
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York, United Kingdom
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For the most up-to-date information, visit the official listing.
NCT06318169