OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
NCT ID: NCT04757636
Last Updated: 2025-08-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
998 participants
INTERVENTIONAL
2021-03-12
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302
intravitreal injection
2.0 aflibercept
intravitreal injection
2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
2.0 mg OPT-302
intravitreal injection
2.0 aflibercept
intravitreal injection
2.0 mg aflibercept with sham
2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
Sham intravitreal injection administered at 4-weekly intervals.
2.0 aflibercept
intravitreal injection
Sham
intravitreal injection
Interventions
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2.0 mg OPT-302
intravitreal injection
2.0 aflibercept
intravitreal injection
Sham
intravitreal injection
Eligibility Criteria
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Inclusion Criteria
* An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
Exclusion Criteria
* Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
* Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
50 Years
ALL
No
Sponsors
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Opthea Limited
INDUSTRY
Responsible Party
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Locations
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COAST Investigational Site
Phoenix, Arizona, United States
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Arcadia, California, United States
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Huntington Beach, California, United States
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Redlands, California, United States
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Sacramento, California, United States
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Danbury, Connecticut, United States
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Altamonte Springs, Florida, United States
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Boynton Beach, Florida, United States
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Coral Springs, Florida, United States
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Melbourne, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Stuart, Florida, United States
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Winter Haven, Florida, United States
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Marietta, Georgia, United States
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‘Aiea, Hawaii, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Urbana, Illinois, United States
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New Albany, Indiana, United States
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Lenexa, Kansas, United States
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Prairie Village, Kansas, United States
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West Monroe, Louisiana, United States
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Hagerstown, Maryland, United States
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Owings Mills, Maryland, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Jackson, Mississippi, United States
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Independence, Missouri, United States
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St Louis, Missouri, United States
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Edison, New Jersey, United States
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Albuquerque, New Mexico, United States
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Shirley, New York, United States
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Asheville, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Springfield, Oregon, United States
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Kingston, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Greenville, South Carolina, United States
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West Columbia, South Carolina, United States
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Rapid City, South Dakota, United States
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Germantown, Tennessee, United States
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Knoxville, Tennessee, United States
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Abilene, Texas, United States
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Austin, Texas, United States
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Burleson, Texas, United States
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Conroe, Texas, United States
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Dallas, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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Fairfax, Virginia, United States
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Bellevue, Washington, United States
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Spokane, Washington, United States
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Morgantown, West Virginia, United States
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Rosario, Santa Fe Province, Argentina
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Rosario, Sante Fe, Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Mendoza, , Argentina
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Liverpool, New South Wales, Australia
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Parramatta, New South Wales, Australia
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Strathfield, New South Wales, Australia
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Adelaide, South Australia, Australia
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East Melbourne, Victoria, Australia
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Rowville, Victoria, Australia
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Graz, , Austria
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Belo Horizonte, Minas Gerais, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Brampton, Ontario, Canada
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North York, Ontario, Canada
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Ottawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Medellín, Antioquia, Colombia
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Bogotá, Cundinamarca, Colombia
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Cali, Valle del Cauca Department, Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Medellín, , Colombia
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Osijek, , Croatia
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Osijek, , Croatia
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Split, , Croatia
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Zagreb, , Croatia
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Hradec Králové, Cech Republic, Czechia
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Praha 4-Krc, , Czechia
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Roskilde, , Denmark
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tallinn, , Estonia
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Lyon, Rhone, France
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Poitiers, Vienne, France
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Dijon, , France
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Paris, , France
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Tübingen, Baden Wu, Germany
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Cologne, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Berlin, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Pécs, , Hungary
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Zalaegerszeg, , Hungary
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Hyderabad, Andhra Pradesh, India
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Ranchi, Jharkhand, India
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Mysore, Karnataka, India
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Nashik, Maharashtra, India
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Bhubaneswar, Odisha, India
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Madurai, Tamil Nadu, India
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Afula, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Ancona, Perugia, Italy
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Milan, , Italy
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Pisa, , Italy
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Roma, , Italy
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Rome, , Italy
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Rozzano, , Italy
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Riga, , Latvia
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Riga, , Latvia
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Santo Tomas, Batangas, Philippines
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Makati, , Philippines
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Makati City, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Bielsko-Biala, , Poland
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Bydgoszcz, , Poland
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Bydgoszcz, , Poland
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Bytom, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Poznan, , Poland
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Arecibo, , Puerto Rico
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Bratislava, , Slovakia
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Trebišov, , Slovakia
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Trenčín, , Slovakia
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Žilina, , Slovakia
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Seongnam-si, Gyeonggi-do, South Korea
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Suwon, Gyeonggi-do, South Korea
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Busan, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Soeul, , South Korea
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Badalona, Barcelona, Spain
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Majadahonda, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Zaragoza, , Spain
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Plymouth, Devon, United Kingdom
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Westcliff-on-Sea, Essex, United Kingdom
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Manchester, Greater Manchester, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Gorleston-on-Sea, Norfolk, United Kingdom
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Frimley, Surrey, United Kingdom
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Sunderland, Tyne and Wear, United Kingdom
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Leeds, West Yorkshire, United Kingdom
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London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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OPT-302-1005
Identifier Type: -
Identifier Source: org_study_id
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