RecruitingPhase 3NCT06120491

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

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)

Sponsor

AstraZeneca

Enrollment

1,800 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-Sensitive Prostate Cancer

Summary

The intention of the study is to demonstrate superiority of Saruparib (AZD5305) + physician's choice NHA relative to placebo + physician's choice NHA by assessment of radiographic progression-free survival (rPFS) in participants with mCSPC.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This trial tests saruparib (a PARP inhibitor drug) versus placebo in men with metastatic castration-sensitive prostate cancer who have hormone receptor mutations (HRR mutations), alongside new hormonal therapies. **You may be eligible if...** - You are a man 18 or older with metastatic prostate cancer confirmed by biopsy - Your cancer has at least one bone or soft tissue lesion that can be monitored - You are already receiving hormone-suppressing therapy (ADT or orchiectomy) for 14 days to 4 months - Your cancer has a confirmed HRR mutation - Your performance status and organ function are adequate **You may NOT be eligible if...** - You have features of bone marrow failure or MDS/AML - You have small cell, neuroendocrine, or other rare prostate cancer subtypes - You are unable to use contraception during the study and for 6 months after Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSaruparib

Oral

DRUGPlacebo

Oral

DRUGAbiraterone Acetate

Oral

DRUGDarolutamide

Oral

DRUGEnzalutamide

Oral

Locations(410)

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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

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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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São Paulo, Brazil

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São Paulo, Brazil

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São Paulo, 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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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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Malmö, 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, 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

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NCT06120491

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