Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
NCT ID: NCT06120491
Last Updated: 2026-01-21
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
1800 participants
INTERVENTIONAL
2023-11-21
2031-04-30
Brief Summary
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Detailed Description
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All patients will be followed for survival until the end of the study. Independent data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of Saruparib (AZD5305) + physicians choice NHA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: Saruparib (AZD5305) + Physician's Choice NHA
Saruparib (AZD5305) + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Saruparib
Oral
Abiraterone Acetate
Oral
Darolutamide
Oral
Enzalutamide
Oral
Arm 2: Placebo + Physician's Choice NHA
Placebo + physician's choice NHA (Abiraterone, Darolutamide, or Enzalutamide)
Placebo
Oral
Abiraterone Acetate
Oral
Darolutamide
Oral
Enzalutamide
Oral
Interventions
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Saruparib
Oral
Placebo
Oral
Abiraterone Acetate
Oral
Darolutamide
Oral
Enzalutamide
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically documented prostate adenocarcinoma which is de novo or recurrent and castration-sensitive. Participants with pathologic features of small cell, neuroendocrine, sarcomatoid, spindle cell, or signet cell histology are not eligible.
* Metastatic disease as documented by the investigator prior to randomisation, with clear evidence of ≥ 1 bone lesion and/or ≥ 1 soft tissue lesion that is suitable for repeated assessment with CT and/or MRI.
* Participant is receiving ADT with a GnRH analogue or has undergone bilateral orchiectomy starting ≥ 14 days and \< 4 months prior to randomisation.
* ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to randomisation.
* Provision of FFPE tumour tissue sample and blood sample (for ctDNA).
* Confirmed HRRm status by central tumour tissue and/or ctDNA test is required to determine cohort eligibility.
* Adequate organ and bone marrow function as described in study protocol.
* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.
* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.
Exclusion Criteria
* Participants with any known predisposition to bleeding.
* Any history of persisting (\> 2 weeks) severe cytopenia.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD5305 and/or the assigned NHA.
* History of another primary malignancy, with exceptions.
* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy.
* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
* Cardiac criteria, including history of arrhythmia and cardiovascular disease.
* Any prior anticancer pharmacotherapy or surgery for metastatic prostate cancer, with exceptions.
* Prior treatment within 14 days with blood product support or growth factor support.
* Participants who are unevaluable for both bone and soft tissue progression.
18 Years
130 Years
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Kim Nguyen Chi, MD
Role: PRINCIPAL_INVESTIGATOR
BC Cancer, Canada
Arun Azad, MD
Role: PRINCIPAL_INVESTIGATOR
Peter MacCallum Cancer Centre, Australia
Locations
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Research Site
East Syracuse, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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New York, New York, United States
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Shirley, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Durham, North Carolina, United States
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Fayetteville, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Independence, Ohio, United States
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Wooster, Ohio, United States
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Florence, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Bala-Cynwyd, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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York, Pennsylvania, United States
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Providence, Rhode Island, United States
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Myrtle Beach, South Carolina, United States
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North Charleston, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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Flower Mound, Texas, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Plano, 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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Sugar Land, Texas, United States
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Tyler, Texas, United States
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Wichita Falls, Texas, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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St. George, Utah, United States
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Fairfax, Virginia, United States
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Winchester, Virginia, United States
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Spokane, Washington, United States
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Spokane Valley, Washington, United States
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Tacoma, Washington, United States
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Chermside, , Australia
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Darlinghurst, , Australia
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Hyde Park, , Australia
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Kurralta Park, , Australia
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Melbourne, , Australia
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Randwick, , Australia
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South Brisbane, , Australia
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Graz, , Austria
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Innsbruck, , Austria
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Krems, , Austria
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Charleroi, , Belgium
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Ghent, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Curitiba, , Brazil
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Pelotas, , 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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Salvador, , Brazil
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São Luís, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Abbotsford, British Columbia, Canada
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Concepción, , Chile
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La Serena, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Dongguan, , China
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Guangzhou, , China
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Guilin, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Jiaxing, , China
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Jinan, , China
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Lanzhou, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Nantong, , China
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Ningbo, , China
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Shandong, , 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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Shenyang, , China
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Suining, , China
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Taiyuan, , China
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Tianjin, , China
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Weifang, , China
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Wenzhou, , China
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Wuhan, , China
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Xi'an, , China
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Yantai, , China
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Zhengzhou, , China
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Helsinki, , Finland
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Tampere, , Finland
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Turku, , Finland
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Angers, , France
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Bayonne, , France
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Bordeaux, , France
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Caen, , France
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Clermont-Ferrand, , France
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Créteil, , France
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Lyon, , France
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Montpellier, , France
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Nice, , France
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Nîmes, , France
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Poitiers, , France
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Quimper, , France
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Rennes, , France
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Strasbourg, , France
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Tours, , France
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Vandœuvre-lès-Nancy, , France
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Bergisch Gladbach, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Braunschweig, , Germany
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Cologne, , Germany
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Dresden, , Germany
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Duisburg, , Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Herne, , Germany
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Homburg, , Germany
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Mannheim, , Germany
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Mettmann, , Germany
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München, , Germany
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Münster, , Germany
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Nürtingen, , Germany
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Oldenburg, , Germany
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Regensburg, , Germany
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Stuttgart, , Germany
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Trier, , Germany
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Tübingen, , Germany
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Ulm, , Germany
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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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Győr, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Szeged, , Hungary
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Szekszárd, , Hungary
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Bangalore, , India
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Calicut, , India
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Delhi, , India
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Hyderabad, , India
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Jaipur, , India
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Kanpur, , India
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Kolkata, , India
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Kolkata, , India
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Mohali, , India
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Nagpur, , India
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New Delhi, , India
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New Delhi, , India
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Pune, , India
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Surat, , India
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Vadodara, , India
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Varanasi, , India
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Bari, , Italy
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Genoa, , Italy
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Meldola, , Italy
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Milan, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Rome, , Italy
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Rozzano, , Italy
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Terni, , Italy
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Trento, , Italy
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Chiba, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hirakata-shi, , Japan
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Hirosaki-shi, , Japan
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Kanazawa, , Japan
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Kashihara-shi, , Japan
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Kawagoe-shi, , Japan
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Kisarazu-shi, , Japan
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Kita-gun, , Japan
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Kobe, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
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Maebashi, , Japan
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Nagano, , Japan
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Nagasaki, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Sagamihara-shi, , Japan
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Sakura-shi, , Japan
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Sapporo, , Japan
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Shiwa-gun, , Japan
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Suita-shi, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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Yufu-shi, , Japan
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George Town, , Malaysia
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Johor Bahru, , Malaysia
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Kota Kinabalu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuching, , Malaysia
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Amsterdam, , Netherlands
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Hilversum, , Netherlands
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Nijmegen, , Netherlands
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Arequipa, , Peru
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Bellavista, , 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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Bydgoszcz, , Poland
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Koszalin, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Żory, , Poland
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San Juan, , Puerto Rico
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Daejeon, , South Korea
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Seongnam-si, , 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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Suwon, , South Korea
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Barcelona, , Spain
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Córdoba, , Spain
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L'Hospitalet de Llobregat, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Sabadell, , Spain
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Valencia, , Spain
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Gothenburg, , Sweden
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Malmo, , Sweden
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Solna, , Sweden
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Stockholm, , Sweden
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taoyuan District, , Taiwan
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Yung Kang City, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khlong Luang, , Thailand
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Songkhla, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Bornova-Izmir, , Turkey (Türkiye)
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Fatih-Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Karşıyaka, , Turkey (Türkiye)
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Aberdeen, , United Kingdom
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Birmingham, , United Kingdom
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Cambridge, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Oxford, , United Kingdom
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Plymouth, , United Kingdom
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Preston, , United Kingdom
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Swansea, , United Kingdom
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Truro, , United Kingdom
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Springdale, Arkansas, United States
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Bakersfield, California, United States
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Fountain Valley, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Montebello, California, United States
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Pasadena, California, United States
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Pomona, California, United States
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Sacramento, 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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Santa Barbara, California, United States
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Santa Monica, California, United States
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Santa Rosa, California, United States
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Golden, Colorado, United States
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Lakewood, Colorado, United States
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New Haven, Connecticut, United States
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Norwich, Connecticut, United States
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Newark, Delaware, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Palm Bay, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Glenview, Illinois, United States
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Lake Barrington, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Westwood, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Shreveport, Louisiana, United States
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Scarborough, Maine, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Towson, Maryland, United States
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Upper Marlboro, Maryland, United States
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Grand Rapids, Michigan, United States
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Troy, Michigan, United States
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Rochester, Minnesota, United States
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Columbia, Missouri, United States
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Billings, Montana, United States
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Bozeman, Montana, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Belleville, New Jersey, United States
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Brick, New Jersey, United States
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Camden, New Jersey, United States
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East Brunswick, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Rio Rancho, New Mexico, United States
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Albany, New York, United States
Countries
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Central Contacts
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Other Identifiers
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2023-504214-30-00
Identifier Type: OTHER
Identifier Source: secondary_id
D9723C00001
Identifier Type: -
Identifier Source: org_study_id
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