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Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
NCT06120491 · AstraZeneca
In plain English
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Official title
A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)
About this study
Approximately 1800 adult participants with mCSPC will be assigned to one of two cohorts (550 HRRm and 1250 non-HRRm) and randomized in a 1:1 ratio to receive either Saruparib (AZD5305) with NHA or placebo with NHA. They will receive their assigned treatment and regular tumor evaluation scans until disease progression, or until treatment is stopped for another reason.
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.
Eligibility criteria
Inclusion Criteria:
* Male ≥ 18 years of age.
* 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 a history of MDS/AML or with features suggestive of MDS/AML (as determined by prior diagnostic investigation). In case there is no clinical MDS/AML suspicion, no specific screening for MDS/AML (by BM/bone biopsy) is required.
* 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.
Study design
Enrollment target: 1800 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-11-21
Estimated completion: 2031-04-30
Last updated: 2026-04-03
Interventions
Drug: SaruparibDrug: PlaceboDrug: Abiraterone AcetateDrug: DarolutamideDrug: Enzalutamide
Primary outcomes
- • Radiographic Progression-Free Survival (rPFS) (Up to approximately 50 months)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
InvestigatorKim Nguyen Chi, MD · principal_investigator, BC Cancer, Canada
InvestigatorArun Azad, MD · principal_investigator, Peter MacCallum Cancer Centre, Australia
All locations (410)
Research SiteActive Not Recruiting
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
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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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Calgary, Alberta, Canada
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Abbotsford British Columbia, British Columbia, Canada
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Abbotsford British Columbia, 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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Santiago, Chile
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Santiago, Chile
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Santiago, 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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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Beijing, China
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Changchun, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Chongqing, China
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Dongguan, China
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Guangzhou, 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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Paris, France
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Pierre-Bénite, 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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Magdeburg, Germany
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Mannheim, Germany
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Marburg, 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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Naples, Italy
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Padova, 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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Nagoya, Japan
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Osaka, Japan
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Osakasayama-shi, 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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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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Cordaleo, Turkey (Türkiye)
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Fatih-Istanbul, Turkey (Türkiye)
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Istanbul, 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