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A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Sponsor: Akero Therapeutics, Inc
Summary
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3). The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1650
Start Date
2023-12-01
Completion Date
2032-11
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Efruxifermin
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Locations (347)
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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Mesa, Arizona, United States
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Peoria, 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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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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Chula Vista, California, 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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Inglewood, California, United States
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La Mesa, California, United States
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Lancaster, 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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Los Angeles, 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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Palm Springs, 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 Diego, California, United States
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San Diego, California, United States
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San Diego, 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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Santa Maria, 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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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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Doral, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah Gardens, Florida, United States
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Inverness, Florida, United States
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Jacksonville, 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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Largo, Florida, United States
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Lehigh Acres, Florida, United States
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Maitland, 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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Miami Lakes, 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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Pembroke Pines, Florida, United States
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Port Orange, 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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West Palm Beach, Florida, United States
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Weston, Florida, United States
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Winter Park, Florida, United States
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Winter Park, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Gainesville, Georgia, United States
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Marietta, 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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Wichita, 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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Marrero, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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New Orleans, 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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Glen Burnie, Maryland, United States
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Greenbelt, Maryland, United States
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South Dartmouth, Massachusetts, United States
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Novi, Michigan, United States
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Southfield, Michigan, United States
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Wyoming, Michigan, United States
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Ypsilanti, Michigan, 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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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Florham Park, New Jersey, United States
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Ridgewood, 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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Santa Fe, New Mexico, United States
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Buffalo, 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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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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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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New Bern, 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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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Springboro, Ohio, United States
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Westlake, Ohio, United States
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Medford, Oregon, 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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Chattanooga, Tennessee, 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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Forney, Texas, United States
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Fort Worth, 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
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Houston, Texas, United States
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Lewisville, Texas, United States
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McAllen, Texas, United States
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Pasadena, 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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San Antonio, Texas, United States
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San Antonio, Texas, United States
Akero Clinical Study Site
San Marcos, Texas, United States
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San Marcos, Texas, United States
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Waco, Texas, United States
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Waco, Texas, United States
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Webster, Texas, United States
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Wichita Falls, Texas, United States
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Ogden, Utah, United States
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Salt Lake City, Utah, United States
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Sandy City, Utah, United States
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South Ogden, Utah, United States
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Falls Church, Virginia, United States
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Newport News, Virginia, United States
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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
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Roanoke, Virginia, United States
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Suffolk, Virginia, United States
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Seattle, Washington, United States
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Spokane, 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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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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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Broadmeadow, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Liverpool, New South Wales, Australia
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Penrith, New South Wales, Australia
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Westmead, New South Wales, Australia
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Adelaide, South Australia, Australia
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Caulfield South, Victoria, Australia
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Epping, Victoria, Australia
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Frankston, 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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Edmonton, Alberta, Canada
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Hamilton, 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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Montreal, Quebec, Canada
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Terrebonne, Quebec, Canada
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Nice, Alpes-Maritimes, France
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Lyon, Auvergne-Rhône-Alpes, France
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Strasbourg, Bas-Rhin, France
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Limoges, Haute-Vienne, 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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Versailles, Yvelines, Île-de-France, France
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Paris, Île-de-France Region, France
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Würzburg, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Mainz, Rhineland-Palatinate, Germany
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Leipzig, Saxony, 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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Berlin, Germany
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Surat, Gujarat, India
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Vadodara, Gujarat, India
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Thiruvananthapuram, Kerala, India
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Dahegaon, 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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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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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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Haifa, Haifa District, Israel
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Afula, Northern District, Israel
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Nahariya, Northern District, Israel
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Nazareth, Northern District, Israel
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Jerusalem, Israel
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Jerusalem, Israel
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Tel Aviv, Israel
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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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Foggia, 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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Naples, Italy
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Novara, Italy
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Cuauhtémoc, 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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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Gdynia, Pomeranian Voivodeship, Poland
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Częstochowa, Silesian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Lodz, Łódź 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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Goyang-si, Gyeonggi-do, South Korea
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Incheon, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Seongnam-si, Gyeonggido [Kyonggi-do], 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 [Seoul-T'ukpyolshi], 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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Valencia, València, Spain
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Valencia, València, 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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Olten, Canton of Solothurn, Switzerland
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Bern, Switzerland
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Sankt Gallen, Switzerland
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Changhua, Changhua, Taiwan
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Taichung, Taichung, Taiwan
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Tainan, Tainan, Taiwan
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Taipei City, Taipei, Taiwan
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Kaohsiung City, Taiwan
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Tainan, Taiwan
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Taoyuan District, Taiwan
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Yenimahalle, Ankara, Turkey (Türkiye)
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Bornova, İzmir, Turkey (Türkiye)
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Bursa, Turkey (Türkiye)
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Rize, Turkey (Türkiye)
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Birmingham, England, United Kingdom
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Cambridge, England, United Kingdom
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Liverpool, England, United Kingdom
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London, England, United Kingdom
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London, England, United Kingdom
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London, England, United Kingdom
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London, England, United Kingdom
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London, England, United Kingdom
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Newcastle upon Tyne, England, United Kingdom