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Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS)
Sponsor: Travere Therapeutics, Inc.
Summary
To determine the long-term nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with primary and genetic focal segmental glomerulosclerosis (FSGS).
Official title: A Randomized, Multicenter, Double-blind, Parallel, Active-control Study of the Effects of Sparsentan, a Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients With Primary FSGS
Key Details
Gender
All
Age Range
8 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
371
Start Date
2018-04-17
Completion Date
2026-02
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
sparsentan
Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
Irbesartan
target dose of 300 mg daily
Locations (225)
Travere Investigational Site
Mesa, Arizona, United States
Travere Investigational Site
Phoenix, Arizona, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Palo Alto, California, United States
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San Diego, California, United States
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San Dimas, California, United States
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San Francisco, California, United States
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Torrance, California, United States
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Victorville, California, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Middlebury, Connecticut, United States
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Wilmington, Delaware, United States
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Washington D.C., District of Columbia, United States
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Coral Springs, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Port Charlotte, Florida, United States
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Temple Terrace, Florida, United States
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Winter Park, Florida, United States
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Lawrenceville, Georgia, United States
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Nampa, Idaho, United States
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Chicago, Illinois, United States
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Hinsdale, Illinois, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Monroe, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Kansas City, 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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Reno, Nevada, United States
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Hackensack, New Jersey, United States
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Fresh Meadows, New York, United States
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New Hyde Park, 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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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Durham, 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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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Roseburg, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Camp Hill, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Columbia, South Carolina, 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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El Paso, 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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Lewisville, Texas, United States
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Sherman, Texas, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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St. George, Utah, United States
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Hampton, Virginia, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
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Marshfield, Wisconsin, United States
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Wauwatosa, Wisconsin, United States
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Buenos Aires, Argentina
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Córdoba, Argentina
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Córdoba, Argentina
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Santa Fe, Argentina
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Concord, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Saint Leonards, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Birtinya, Queensland, Australia
Travere Investigational Site
Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
Travere Investigational Site
Parkville, Victoria, Australia
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Nedlands, Western Australia, Australia
Travere Investigational Site
Leuven, Belgium
Travere Investigational Site
Liège, Belgium
Travere Investigational Site
Roeselare, Belgium
Travere Investigational Site
Botucatu, Brazil
Travere Investigational Site
Itaquera, Brazil
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Passo Fundo, Brazil
Travere Investigational Site
Porto Alegre, Brazil
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Recife, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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São Paulo, Brazil
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Edmonton, Alberta, Canada
Travere Investigational Site
London, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Zagreb, Croatia
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Prague, Prague, Czechia
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Prague, Prague, Czechia
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Nový Jičín, Czechia
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Aarhus, Central Jutland, Denmark
Travere Investigational Site
Kolding, Southern Denmark, Denmark
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Tallinn, Estonia
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Tartu, Estonia
Travere Investigational Site
Bordeaux, France
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Clermont-Ferrand, France
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Créteil, France
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Grenoble, France
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Marseille, 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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Saint-Priest-en-Jarez, France
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Toulouse, France
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Valenciennes, France
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Düsseldorf, Westfalen, Germany
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Aachen, Germany
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Berlin, Germany
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Berlin, Germany
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Hanover, Germany
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Stuttgart, Germany
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Villingen-Schwenningen, Germany
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Hong Kong, Hong Kong
Travere Investigational Site
Lai Chi Kok, Hong Kong
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Bari, Italy
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Bergamo, Italy
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Bologna, Italy
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Florence, Italy
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Genova, Italy
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Germaneto, Italy
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Lecco, Italy
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Milan, Italy
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Monza, Italy
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Pavia, Italy
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Roma, Italy
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Verona, Italy
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Auckland, New Zealand
Travere Investigational Site
Hamilton, New Zealand
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Lodz, Poland
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Olsztyn, Poland
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Olsztyn, Poland
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Piotrkow Trybunalski, Poland
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Warsaw, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Amadora, Portugal
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Carnaxide, Portugal
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Lisbon, Portugal
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Lisbon, Portugal
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Loures, Portugal
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Porto, Portugal
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Setúbal, Portugal
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Vila Nova de Gaia, Portugal
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Busan, South Korea
Travere Investigational Site
Daejeon, South Korea
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Gyeonggi-do, South Korea
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Gyeonggi-do, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Palma de Mallorca, Balearic Islands, Spain
Travere Investigational Site
Lugo, Burela, Spain
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Sagunto, Valencia, Spain
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Badalona, 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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Ciudad Real, Spain
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Córdoba, Spain
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Madrid, Spain
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Madrid, Spain
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Majadahonda, Spain
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Málaga, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Seville, Spain
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Valencia, Spain
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Valencia, Spain
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Zaragoza, Spain
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Solna, Sweden
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Uppsala, Sweden
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Uppsala, Sweden
Travere Investigational Site
Hualien City, Taiwan
Travere Investigational Site
Kaohsiung City, Taiwan
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New Taipei City, Taiwan
Travere Investigational Site
Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Carshalton, London, United Kingdom
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Whitechapel, London, United Kingdom
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Fulwood, Preston, United Kingdom
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Brighton, United Kingdom
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Leicester, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle, United Kingdom
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Reading, United Kingdom
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Salford, United Kingdom
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Swansea, United Kingdom
Travere Investigational Site
York, United Kingdom