OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
NCT ID: NCT04757610
Last Updated: 2025-07-22
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
986 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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0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302
intravitreal injection
0.5 mg ranibizumab
intravitreal injection
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection administered at 4-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
0.5 mg ranibizumab
intravitreal injection
0.5 mg ranibizumab with sham
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
Sham intravitreal injection administered at 4-weekly intervals.
0.5 mg ranibizumab
intravitreal injection
Sham
intravitreal injection
Interventions
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2.0 mg OPT-302
intravitreal injection
0.5 mg ranibizumab
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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ShORe Investigational Site
Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Bakersfield, California, United States
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Campbell, California, United States
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Encino, California, United States
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Fullerton, California, United States
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Glendale, California, United States
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Huntington Beach, California, United States
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Laguna Hills, 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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Mountain View, California, United States
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Palm Desert, California, United States
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Pasadena, California, United States
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Poway, California, United States
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Redlands, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Torrance, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Lakewood, Colorado, United States
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Longmont, Colorado, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Lakeland, Florida, United States
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Pensacola, Florida, United States
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Pinellas Park, Florida, United States
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Temple Terrace, Florida, United States
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Augusta, Georgia, United States
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Sandy Springs, Georgia, United States
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Lemont, Illinois, United States
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Indianapolis, Indiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Hagerstown, Maryland, United States
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Towson, Maryland, United States
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Springfield, Massachusetts, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Bloomfield, New Jersey, United States
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Toms River, New Jersey, United States
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Hauppauge, New York, United States
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Liverpool, New York, United States
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Wake Forest, North Carolina, United States
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Fargo, North Dakota, United States
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Edmond, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Erie, Pennsylvania, United States
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Beaufort, South Carolina, United States
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Ladson, South Carolina, United States
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Nashville, Tennessee, United States
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Arlington, 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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Dallas, Texas, United States
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Houston, Texas, United States
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Katy, 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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Tyler, Texas, United States
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Willow Park, Texas, United States
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Salt Lake City, Utah, United States
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Charlottesville, Virginia, United States
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Lynchburg, Virginia, United States
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Capital Federal, Ciudad Autonoma Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Sante Fe, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Córdoba, , Argentina
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Hurstville, New South Wales, Australia
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Melbourne, Victoria, Australia
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Vitória, Cordoba, Brazil
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Goiânia, Goiás, Brazil
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Faxinal do Soturno, Rio Grande do Sul, Brazil
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Blumenau, Santa Catarina, Brazil
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Santo André, 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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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Mississauga, Ontario, Canada
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Medellín, , Colombia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Sokolov, , Czechia
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Aarhus, , Denmark
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Glostrup Municipality, , Denmark
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Sønderborg, , Denmark
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Nice, Alpes-Maritimes, France
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Strasbourg, Bas Rhin, France
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Écully, Rhone, France
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Créteil, Val de Marr, France
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Ulm, Baden Wuerttermberg, Germany
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Heidelberg, Baden-Wurttemberg, Germany
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Goettigen, Lower Saxony, Germany
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Düsseldorf, Nordrhein, Germany
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Münster, Nordrhein, Germany
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Bonn, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Hamburg, , Germany
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Athens, , Greece
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Ioannina, , Greece
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Pátrai, , Greece
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Budapest, , Hungary
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Miskolc, , Hungary
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Szombathely, , Hungary
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Ahmedabad, Gujarat, India
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Surat, Gujarat, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Pune, Maharashtra, India
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Chandigarh, Punjab, India
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Coimbatore, Tamil Nadu, India
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Lucknow, Uttar Pradesh, India
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Kolkata, West Bengal, India
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Mysuru, , India
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Beersheba, , Israel
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Haifa, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Rishon LeZiyyon, , Israel
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Catanzaro, Reggio Calabria, Italy
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Bologna, , Italy
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Chieti, , Italy
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Genova, , Italy
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Roma, , Italy
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Siena, , Italy
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Udine, , Italy
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Riga, , Latvia
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Batu Caves, Selangor, Malaysia
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Shah Alam, Selangor, Malaysia
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Kuala Lumpur, , Malaysia
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Gdansk, , Poland
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Krakow, , Poland
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Olsztyn, , Poland
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Szczecin, , Poland
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Tarnowskie Góry, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Seongnam-si, Gyeonggi-do, South Korea
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Daegu, Gyeongsangbuk-do, South Korea
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Busan, , South Korea
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Busan, , South Korea
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Gwangju, , 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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Seoul, , South Korea
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Sant Cugat del Vallès, Barcelona, Spain
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Alcalá de Henares, Madrid, Spain
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Pamplona, Navarre, Spain
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Burjassot, Valencia, Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Burgos, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Valencia, , Spain
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Pathum Wan, Bangkok, Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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Pathum Thani, , Thailand
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Kiev, , Ukraine
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Crewe, Cheshire, United Kingdom
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Southampton, Hampshire, United Kingdom
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Leicester, Leicestershire, United Kingdom
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Bristol, Somerset, United Kingdom
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Guildford, Surrey, United Kingdom
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Wolverhampton, West Midlands, United Kingdom
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London, , 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-302-1004
Identifier Type: -
Identifier Source: org_study_id
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