A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
NCT ID: NCT00626548
Last Updated: 2012-09-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2577 participants
INTERVENTIONAL
2008-01-31
2011-05-31
Brief Summary
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This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.
All patients participating in this clinical trial will receive existing prostate cancer treatments in addition to trial therapy.
Half the patients will receive ZD4054 (Zibotentan) , and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.
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
TRIPLE
Study Groups
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Placebo
Matching Placebo
Palcebo
Matching Plcebo oral tablet once daily
ZD4054
ZD4054 (Zibotentan)
ZD4054
10 mg once daily oral dose
Interventions
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ZD4054
10 mg once daily oral dose
Palcebo
Matching Plcebo oral tablet once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
* Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
* Currently receiving treatment with surgical or medical castration
Exclusion Criteria
* Currently using opiate based pain killers for cancer related pain
* Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial
* Suffering from heart failure or had a myocardial infarction within last 6 months
* A history of epilepsy or seizures
18 Years
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Kurt Miller, Prof., M.D.
Role: PRINCIPAL_INVESTIGATOR
Charite University, Berlin, Germany
Tia Higano, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Tucson, Arizona, United States
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Greenbrae, California, United States
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Los Angeles, 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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Denver, Colorado, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Boca Raton, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Port Saint Lucie, Florida, United States
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Atlanta, Georgia, United States
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Macon, Georgia, United States
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Kansas City, Kansas, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Rockville, Maryland, United States
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Minneapolis, Minnesota, United States
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Lincoln, Nebraska, United States
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Las Vegas, Nevada, United States
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Brooklyn, New York, United States
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Chapel Hill, North Carolina, United States
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Bismarck, North Dakota, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Mystle Beach, South Carolina, United States
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Raleigh, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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San Antonio, Texas, United States
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Burlington, Vermont, United States
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Seattle, Washington, United States
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Wenatchee, Washington, United States
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Milwaukee, Wisconsin, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Darlinghurst, New South Wales, Australia
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Hornsby, New South Wales, Australia
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Westmead, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Wodonga, Victoria, Australia
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Nedlands, Western Australia, Australia
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Sydney, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Wels, , Austria
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(Wilrijk) Antwerpen, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Goiânia, Goiás, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Londrina, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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Kingston, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfeild Park, Quebec, Canada
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Montreal, Quebec, Canada
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Point-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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La Serena, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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Nanjing, Jiangsu, China
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Hangzhou, Zhejiang, China
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Beijing, , China
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Chongqing, , China
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Guangzhou, , China
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Hubei, , China
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Jiangsu, , China
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Shanghai, , China
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Shanxi, , China
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Tianjin, , China
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Zejiang, , China
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Bogotá, , Colombia
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Medellín, , Colombia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Jablonec nad Nisou, , Czechia
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Kroměříž, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Aalborg, , Denmark
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Copenhagen, , Denmark
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Frederiksberg, , Denmark
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Herlev, , Denmark
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Holstebro, , Denmark
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Odense, , Denmark
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Roskilde, , Denmark
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Helsinki, , Finland
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Joensuu, , Finland
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Oulu, , Finland
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Seinäjoki, , Finland
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Tampere, , Finland
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Caen, , France
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Créteil, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Orléans, , France
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Paris, , France
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Pierre-Bénite, , France
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Poitiers, , France
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Reims, , France
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Rennes, , France
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Rouen, , France
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Suresnes, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Augsburg, , Germany
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Bad Ems, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Borken, , Germany
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Chemnitz, , Germany
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Emmendingen, , Germany
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Fürth, , Germany
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Gelsenkirchen-Buer, , Germany
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Germering, , Germany
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Göttingen, , Germany
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Holzminden, , Germany
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Kirchheim/Teck, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Mannheim, , Germany
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Muehlheim An Der Ruhr, , Germany
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Muenchen-Planegg, , Germany
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Mühlacker, , Germany
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München, , Germany
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Münster, , Germany
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Reutlingen, , Germany
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Rostock, , Germany
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Tübingen, , Germany
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Waltshut-Tiengen, , Germany
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Wuppertal, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Győr, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Szeged, , Hungary
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Székesfehérvár, , Hungary
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Ahmedabad, Gujarat, India
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Nadiād, Gujarat, India
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Kochi, Kerala, India
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Pune, Maharashtra, India
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Chennai, Tamil Nadu, India, India
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Lucknow, Uttar Pradesh, India
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Kolkota, West Bengal, India
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New Delhi, , India
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Dublin, , Ireland
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Beersheba, , Israel
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Be’er Ya‘aqov, , Israel
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Haifa, , Israel
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Holon, , Israel
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Jeruslaem, , Israel
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Petah Tikva, , Israel
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Tel-HaShomer - Ramat Gan, , Israel
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Ancona, , Italy
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Bari, , Italy
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Bergamo, , Italy
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Bologna, , Italy
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Catania, , Italy
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Como, , Italy
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Florence, , Italy
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Genova, , Italy
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Messina, , Italy
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Milan, , Italy
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Pisa, , Italy
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Rome, , Italy
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Terni, , Italy
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Varese, , Italy
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Hirosaki, Aomori, Japan
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Chiba, Chiba, Japan
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Narashino, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukuoka, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Ōtake, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Kobe, Hyōgo, Japan
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Ibaraki-machi, Ibaraki, Japan
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Mito, Ibaraki, Japan
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Tsukuba, Ibaraki, Japan
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Kita-gun, Kagawa-ken, Japan
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Sagamihara, Kanagawa, Japan
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Kamigyō-ku, Kyoto, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Ueda, Nagano, Japan
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Nagasaki, Nagasaki, Japan
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Kashihara, Nara, Japan
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Ōita, Oita Prefecture, Japan
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Kurashiki, Okayama-ken, Japan
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Osaka, Osaka, Japan
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Ōsaka-sayama, Osaka, Japan
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Suita, Osaka, Japan
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Wako, Saitama, Japan
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Hamamatsu, Shizuoka, Japan
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Sunto-gun, Shizuoka, Japan
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Bunkyo-ku, Tokyo, Japan
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Fuchu_city, Tokyo, Japan
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Itabashi-Ku, Tokyo, Japan
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Meguro-ku, Tokyo, Japan
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Minato-Ku, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Liepāja, , Latvia
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Riga, , Latvia
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Distrito Federal, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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's-Hertogenbosch, , Netherlands
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Eindhoven, , Netherlands
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Nijmegen, , Netherlands
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Rotterdam, , Netherlands
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Tilburg, , Netherlands
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Trondheim, , Norway
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Tønsberg, , Norway
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Arequipa, , Peru
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Bellavista, , Peru
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Jesus Maria, , Peru
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Lima, , Peru
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Gdynia, , Poland
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Kielce, , Poland
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Kościerzyna, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Coimbra, , Portugal
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Porto, , Portugal
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Timișoara, Timiș County, Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Omsk, Omsk Oblast, Russia
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Izhevsk, Russia, Russia
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Tomsk, Tomsk Oblast, Russia
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Barnaul, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Sochi, , Russia
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Voronezh, , Russia
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Belgrade, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Observatory, Cape Town, South Africa
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Tygerberg, Cape Town, South Africa
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Overport, Durban, South Africa
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Parktown, Johannesburg, South Africa
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Pietermaritzburg, , South Africa
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Pretoria, , South Africa
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Seo-gu, Busan, South Korea
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Bundang-Gu, Seongnam-si, Gyeonggi-do, South Korea
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Gangnam-gu, Seoul, South Korea
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Seodaemun-gu, Seoul, South Korea
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Seongbuk-gu, Seoul, South Korea
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Songpa-gu, Seoul, South Korea
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Elche, Alicante, Spain
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Barakaldo, Bizkaia, Spain
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Bilbao, Vizcaya, Spain
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A Corunna, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Seville, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Helsingborg, , Sweden
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Jönköping, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Aarau, , Switzerland
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Ch-4031 Basel, , Switzerland
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Locarno, , Switzerland
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Zurich, , Switzerland
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Reading, Berkshire, United Kingdom
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Cottingham, East Yorkshire, United Kingdom
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Stevenage, Hertfordshire, United Kingdom
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Maidstone, Kent, United Kingdom
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Guildford, Surrey, United Kingdom
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Cambridge, , United Kingdom
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Coventry, , United Kingdom
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Glasgow, , United Kingdom
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Huddersfield, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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D4320C00015
Identifier Type: -
Identifier Source: org_study_id