A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
Akero Therapeutics, Inc
1,150 participants
Sep 4, 2024
INTERVENTIONAL
Conditions
Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
Eligibility
Inclusion Criteria2
- Cohort 1: Biopsy proven compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
- Cohort 2: Biopsy proven or non-invasively diagnosed compensated cirrhosis (fibrosis stage 4) due to NASH/MASH
Exclusion Criteria3
- Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results
- Type 1 diabetes or unstable Type 2 diabetes
- Any current or prior history of decompensated liver disease
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Interventions
Administered by subcutaneous injection
Administered by subcutaneous injection
Locations(316)
Akero Clinical Study Site
Birmingham, Alabama, United States
Akero Clinical Study Site
Dothan, Alabama, United States
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Chandler, Arizona, United States
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Flagstaff, Arizona, United States
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Peoria, Arizona, United States
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Scottsdale, Arizona, United States
Akero Clinical Study Site
Tucson, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Conway, Arkansas, United States
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Jonesboro, 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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Coronado, California, United States
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Escondido, California, United States
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Folsom, 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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Newport Beach, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Redwood City, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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Tarzana, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Englewood, Colorado, United States
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New Haven, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Cutler Bay, Florida, United States
Akero Clinical Study Site
Doral, 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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Inverness, Florida, United States
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Lakewood Rch, Florida, United States
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Largo, Florida, United States
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Lehigh Acres, Florida, United States
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Margate, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Gardens, Florida, United States
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Naples, 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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Orlando, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Riverview, Florida, United States
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Sarasota, Florida, United States
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Temple Terrace, Florida, United States
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Venice, Florida, United States
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Viera, Florida, United States
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Weston, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Gainesville, Georgia, United States
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Marietta, Georgia, United States
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Snellville, Georgia, United States
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Chicago, Illinois, United States
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Hammond, Indiana, United States
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Indianapolis, Indiana, United States
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South Bend, Indiana, United States
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West Des Moines, Iowa, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Bastrop, Louisiana, United States
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Covington, Louisiana, United States
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Houma, Louisiana, United States
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Lafayette, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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West Monroe, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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South Dartmouth, Massachusetts, United States
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Clinton Township, Michigan, United States
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Novi, Michigan, United States
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Southfield, Michigan, United States
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Rochester, Minnesota, United States
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Flowood, Mississippi, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Jackson, New Jersey, United States
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Somers Point, New Jersey, United States
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Sparta, New Jersey, United States
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Buffalo, New York, United States
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Manhasset, 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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New York, New York, United States
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Rochester, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, 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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Statesville, 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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Oklahoma City, Oklahoma, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Summerville, South Carolina, United States
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Clarksville, 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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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Denison, Texas, United States
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Edinburg, Texas, United States
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Edinburg, Texas, United States
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Fort Sam Houston, Texas, United States
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Fort Worth, Texas, United States
Akero Clinical Study Site
Garland, 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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Houston, Texas, United States
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Houston, Texas, United States
Akero Clinical Study Site
Pasadena, Texas, United States
Akero Clinical Study Site
Pharr, 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
Akero Clinical Study Site
Sugar Land, Texas, United States
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Sugar Land, Texas, United States
Akero Clinical Study Site
Waco, Texas, United States
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Waco, Texas, United States
Akero Clinical Study Site
Webster, Texas, United States
Akero Clinical Study Site
Wichita Falls, Texas, United States
Akero Clinical Study Site
Norfolk, 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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Richmond, Virginia, United States
Akero Clinical Study Site
Roanoke, Virginia, United States
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Seattle, Washington, United States
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Madison, Wisconsin, United States
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Ramos Mejía, Buenos Aires, Argentina
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Buenos Aires, Distrito Federal, Argentina
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Rosario, Sante Fe, Argentina
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Buenos Aires, Argentina
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Broadmeadow, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Westmead, New South Wales, Australia
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Herston, Queensland, Australia
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Adelaide, South Australia, Australia
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Box Hill, Victoria, Australia
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Clayton, Victoria, Australia
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Epping, Victoria, Australia
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Murdoch, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Brasília, Federal District, Brazil
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Goiânia, Goiás, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Edmonton, Alberta, 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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Montreal, Quebec, Canada
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Terrebonne, Quebec, Canada
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La Serena, Coquimbo Region, Chile
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Las Condes, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Strasbourg, Bas-Rhin, France
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Limoges, Haute-Vienne, France
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Lille, Hauts-de-France, France
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Clichy, Hauts-de-Seine, France
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Vandœuvre-lès-Nancy, Lorraine, France
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Angers, Maine-et-Loire, France
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Toulouse, Occitanie, France
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Marseille, Provence-Alpes-Côte d'Azur Region, France
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Montpellier Cedex 5, Provence-Alpes-Côte d'Azur Region, France
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Nice, Provence-Alpes-Côte d'Azur Region, France
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Lyon, Rhône, France
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Créteil, Val-de-Marne, France
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Le Chesnay, Île-de-France Region, France
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Paris, Île-de-France Region, France
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Frankfurt am Main, Hesse, Germany
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Homburg, Saarland, Germany
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Leipzig, Saxony, Germany
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Leipzig, Saxony, Germany
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Lübeck, Schleswig-Holstein, Germany
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Berlin, Germany
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Hyderabad, Andhra Pradesh, India
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Surat, Gujarat, India
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Surat, Gujarat, India
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Vadodara, Gujarat, India
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Mysore, Karnataka, India
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Thiruvananthapuram, Kerala, India
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Mumbai, Maharashtra, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
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Chandigarh, Punjab, India
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Ludhiana, Punjab, India
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Jaipur, Rajasthan, India
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Jaipur, Rajasthan, India
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Coimbatore, Tamil Nadu, India
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Hyderabad, Telangana, India
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Varanasi, Uttar Pradesh, India
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Varanasi, Uttar Pradesh, India
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Rishikesh, Uttarakhand, India
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Kolkata, West Bengal, India
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Kolkata, West Bengal, India
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Kolkata, West Bengal, India
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Petah Tikva, Central District, Israel
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Ramat Gan, Central District, Israel
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Haifa, Haifa District, Israel
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Afula, Northern District, Israel
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Nahariya, Northern District, Israel
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Haifa, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Tel Aviv, Israel
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Tel Aviv, Israel
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Foggia, Apulia, Italy
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San Giovanni Rotondo, Foggia, Italy
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Rozzano, Milan, Italy
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Torino, Turin, Italy
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Bologna, Italy
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Catania, Italy
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Messina, Italy
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Milan, Italy
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Milan, Italy
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Modena, Italy
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Novara, Italy
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Acapulco de Juárez, Guerrero, Mexico
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Guadalajara, Jalisco, Mexico
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Cuauhtémoc, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Mérida, Yucatán, Mexico
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Benito Juárez, Mexico
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Mexico City, Mexico
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Poznan, Greater Poland Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Wroclaw, Lower Silesian Voivodeship, Poland
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Lodz, Lódzkie, Poland
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Częstochowa, Silesian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Manatí, Puerto Rico
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Mayagüez, Puerto Rico
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San Juan, Puerto Rico
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Daegu, Daegu Gwang'yeogsi [Taegu-Kwangyokshi], South Korea
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Incheon, Gyeonggi-do, South Korea
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Goyang-si, Gyeonggido, South Korea
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Daegu, Gyeongsangbugdo [Kyongsangbuk-do], South Korea
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Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], South Korea
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Seoul, Seoul Teugbyeolsi, South Korea
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Sabadell, Barcelona, Spain
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Santander, Cantabria, Spain
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Majadahonda, Madrid, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Lugano, Canton Ticino, Switzerland
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Bern, Switzerland
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Sankt Gallen, Switzerland
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Zurich, Switzerland
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Ankara, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Rize, Turkey (Türkiye)
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London, England, United Kingdom
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Nottingham, England, United Kingdom
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Birmingham, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Whitechapel, United Kingdom
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For the most up-to-date information, visit the official listing.
NCT06528314