Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
NCT ID: NCT05742802
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1869 participants
INTERVENTIONAL
2023-03-06
2026-08-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tozorakimab Dose 1
Injection subcutaneously Tozorakimab via pre-filled syringe.
Tozorakimab 1
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Tozorakimab Dose 2
Injection subcutaneously Tozorakimab via pre-filled syringe.
Tozorakimab 2
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Placebo
Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.
Placebo
Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.
Interventions
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Tozorakimab 1
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Tozorakimab 2
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
Placebo
Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.
Eligibility Criteria
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Inclusion Criteria
2. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.
3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
5. Capable of giving signed informed consent.
Exclusion Criteria
2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
4. Known history of:
1. Severe allergic reaction to any monoclonal and polyclonal antibody.
2. Allergy or reaction to any component of the IP formulation.
5. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
6. Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
7. Participants who are not able to comply with the study requirements, procedures, and restrictions.
40 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Huntsville, Alabama, United States
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Sheffield, Alabama, United States
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Tempe, Arizona, United States
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Bakersfield, California, United States
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Lincoln, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Boynton Beach, Florida, United States
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Cape Coral, Florida, United States
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Ormond Beach, Florida, United States
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Pensacola, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Evergreen Park, Illinois, United States
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Normal, Illinois, United States
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Greenwood, Indiana, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Bowling Green, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Zachary, Louisiana, United States
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Baltimore, Maryland, United States
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White Marsh, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Grand Rapids, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Missoula, Montana, 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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Durham, North Carolina, United States
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Gastonia, North Carolina, United States
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Fargo, North Dakota, United States
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Toledo, Ohio, United States
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Tulsa, Oklahoma, United States
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Tulsa, Oklahoma, United States
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DuBois, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Sayre, Pennsylvania, United States
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Rock Hill, South Carolina, United States
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Franklin, Tennessee, United States
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Amarillo, Texas, United States
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Amarillo, Texas, United States
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Boerne, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Kingwood, Texas, United States
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McKinney, Texas, United States
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Tomball, Texas, United States
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Webster, Texas, United States
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Colchester, Vermont, United States
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Williamsburg, Virginia, United States
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Cudahy, Wisconsin, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Quilmes, , Argentina
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San Fernando, , Argentina
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San Juan Bautista, , Argentina
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San Miguel de Tucumán, , Argentina
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Campbelltown, , Australia
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Frankstown, , Australia
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Macquarie University, , Australia
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Melbourne, , Australia
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Nedlands, , Australia
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Southport, , Australia
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Spearwood, , Australia
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Wollongong, , Australia
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Woodville South, , Australia
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Brussels, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Namur, , Belgium
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Blumenau, , Brazil
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Botucatu, , Brazil
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Brasília, , Brazil
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Curitiba, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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São Bernardo do Campo, , 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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Dupnitsa, , Bulgaria
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Kozloduy, , Bulgaria
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Lovech, , Bulgaria
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Petrich, , Bulgaria
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Pleven, , Bulgaria
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Rousse, , Bulgaria
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Sliven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Troyan Municipality, , Bulgaria
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Vratsa, , Bulgaria
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Edmonton, Alberta, Canada
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Sherwood Park, Alberta, Canada
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Ajax, Ontario, Canada
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Guelph, Ontario, Canada
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Winchester, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Québec, Quebec, Canada
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Chile, , Chile
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Curicó, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talca, , Chile
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Baotou, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changde, , China
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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chengdu, , China
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Chongqing, , China
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Chongqing, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Haikou, , China
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Hangzhou, , China
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Hefei, , China
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Hohhot, , China
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Kunming, , China
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Linhai, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Ningbo, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Shenzhen, , China
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Shenzhen, , China
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Shijiazhuang, , China
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Suzhou, , China
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Taiyuan, , China
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Tianjin, , China
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Wuhan, , China
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Wuxi, , China
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Xiamen, , China
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Xuzhou, , China
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Xuzhou, , China
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Yangzhou, , China
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Yinchuan, , China
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Zhanjiang, , China
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Zunyi, , China
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Barranquilla, , Colombia
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Ibagué, , Colombia
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Rionegro, , Colombia
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Zipaquirá, , Colombia
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Brno, , Czechia
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Broumov, , Czechia
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Jihlava, , Czechia
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Jindřichův Hradec, , Czechia
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Liberec, , Czechia
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Olomouc, , Czechia
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Rokycany, , Czechia
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Aalborg, , Denmark
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Copenhagen, , Denmark
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Hvidovre, , Denmark
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Næstved, , Denmark
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Roskilde, , Denmark
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Vejle, , Denmark
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Hämeenlinna, , Finland
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Helsinki, , Finland
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Kuopio, , Finland
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Tampere, , Finland
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Turku, , Finland
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Bordeaux, , France
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Brest, , France
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Dijon, , France
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La Tronche, , France
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Limoges, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Nantes, , France
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Toulouse, , France
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Ahrensburg, , Germany
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Bamberg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Darmstadt, , Germany
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Halle, , Germany
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Marburg, , Germany
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München, , Germany
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München-Pasing, , Germany
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Peine, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Athens, , Greece
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Exohi Thessaloniki, , Greece
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Ioannina, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Edelény, , Hungary
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Encs, , Hungary
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Gyöngyös, , Hungary
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Mosonmagyaróvár, , Hungary
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Nyíregyháza-Sóstóhegy, , Hungary
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Százhalombatta, , Hungary
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Belagavi, , India
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Coimbatore, , India
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Dehradun, , India
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Jaipur, , India
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Nagpur, , India
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Nashik, , India
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New Delhi, , India
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Thāne, , India
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Ashkelon, , Israel
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Beersheba, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Bari, , Italy
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Carrara, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Napoli, , Italy
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Roma, , Italy
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Salerno, , Italy
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Sassari, , Italy
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Statte, , Italy
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Telese Terme, , Italy
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Tradate, , Italy
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Vercelli, , Italy
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Verona, , Italy
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Asahikawa-shi, , Japan
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Chūōku, , Japan
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Fujieda-shi, , Japan
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Fukuoka, , Japan
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Hamamatsu, , Japan
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Hamamatsu, , Japan
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Hiroshima, , Japan
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Iizuka-shi, , Japan
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Itabashi-ku, , Japan
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Iwata-shi, , Japan
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Kanazawa, , Japan
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Kawachinagano-shi, , Japan
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Kobe, , Japan
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Matsusaka-shi, , Japan
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Mizunami-shi, , Japan
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Nagoya, , Japan
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Obihiro, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Shinjuku-ku, , Japan
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Shizuoka, , Japan
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Toshima-ku, , Japan
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Toyonaka-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Benito Juárez, , Mexico
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mérida, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Oaxaca City, , Mexico
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Veracruz, , Mexico
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Eindhoven, , Netherlands
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Groningen, , Netherlands
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Harderwijk, , Netherlands
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Heerlen, , Netherlands
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Zutphen, , Netherlands
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Zwolle, , Netherlands
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Bergen, , Norway
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Bodø, , Norway
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Lørenskog, , Norway
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Oslo, , Norway
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Tønsberg, , Norway
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Godoy Cruz, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Piura, , Peru
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Baguio City, , Philippines
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Cebu City, , Philippines
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Iloilo City, , Philippines
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Iloilo City, , Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Ostrowiec Świętokrzyski, , Poland
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Ostróda, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Sosnowiec, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Guimarães, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
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Vila Franca de Xira, , Portugal
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Vila Nova de Gaia, , Portugal
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Brasov, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Constanța, , Romania
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Timișoara, , Romania
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Daegu, , South Korea
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Incheon, , South Korea
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Jeonju, , 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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Galdakao, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Pozuelo de Alarcón, , Spain
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Santander, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Hsinchu, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Yunlin, , Taiwan
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Bang Kra So, , Thailand
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Bangkok, , Thailand
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Hat Yai, , Thailand
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Hat Yai, , Thailand
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Khon Kaen, , Thailand
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Muang,, , Thailand
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Muang, , Thailand
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Mueang, , Thailand
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Nakhon Ratchasima, , Thailand
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Bradford, , United Kingdom
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Corby, , United Kingdom
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Corby, , United Kingdom
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Enfield, , United Kingdom
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High Wycombe, , United Kingdom
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Northwood, , United Kingdom
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Preston, , United Kingdom
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Shipley, , United Kingdom
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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2022-501063-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D9180C00008
Identifier Type: -
Identifier Source: org_study_id