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A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Sponsor: Akero Therapeutics, Inc
Summary
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
700
Start Date
2023-11-10
Completion Date
2026-10
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
Efruxifermin
Administered by subcutaneous (SC) injection
Placebo
Administered by SC injection
Locations (211)
Akero 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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Peoria, 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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Cypress, 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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Los Angeles, California, United States
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Los Angeles, California, United States
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Palm Springs, 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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Santa Maria, California, United States
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Englewood, Colorado, United States
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Bradenton, Florida, United States
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Brandon, 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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Maitland, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Port Orange, Florida, United States
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Sarasota, Florida, United States
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The Villages, 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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Winter Park, Florida, United States
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Winter Park, Florida, 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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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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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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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, 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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Southfield, Michigan, United States
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Wyoming, Michigan, United States
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Ypsilanti, Michigan, United States
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Columbia, Missouri, United States
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Kansas City, 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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Brick, New Jersey, United States
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Florham Park, 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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New York, New York, United States
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New York, 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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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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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, 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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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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Edinburg, 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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Lewisville, Texas, United States
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McAllen, 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 Marcos, 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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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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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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Broadmeadow, 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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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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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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Terrebonne, Quebec, Canada
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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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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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Chandigarh, Punjab, 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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Mexico City, Mexico City, Mexico
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Manatí, Puerto Rico
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San Juan, Puerto Rico
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Daegu, Daegu Gwang'yeogsi, 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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Daegu, Gyeongsangbuk-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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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, 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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Liverpool, England, United Kingdom
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London, England, United Kingdom
Akero Clinical Study Site
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