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NCT07652658PHASE2Recruiting

A Phase IIb Study to Evaluate AZD8965 in Participants With IPF.

AstraZeneca

Start Date

6/11/2026

Completion Date

9/14/2028

Summary

This Phase IIb study aims to evaluate the efficacy, safety, and tolerability of 3 doses of AZD8965 treatment compared to placebo in participants with IPF, including those on antifibrotic therapy (nintedanib, pirfenidone, nerandomilast), either alone or in combination, or in those not on antifibrotic therapy.

Detailed Description

This is a Phase IIb, randomized, placebo-controlled, double-blind, parallel-group 24-week study to assess the efficacy, safety and tolerability of three doses of AZD8965 versus placebo administered to participants with IPF. The enrolled participants will include those on stable dose(s) of one or two approved antifibrotic therapies and those who are not taking any antifibrotic therapy. Approximately 360 participants will be randomized across approximately 200 sites globally.

Eligibility Criteria

Age Range: 40 years to No maximum

Inclusion Criteria: 1. Age ≥ 40 years 2. IPF diagnosis 3. Participants with IPF receiving locally approved antifibrotic therapies at a stable dose, or participants with IPF not receiving local standard of care 4. FVC ≥ 45% predicted of normal 5. DLCO corrected for hemoglobin ≥ 25% predicted of normal Exclusion Criteria: 1. ILD other than IPF 2. The extent of emphysema is greater than the extent of fibrotic changes on chest HRCT scan 3. Acute exacerbation of IPF 4. Lower respiratory tract infection requiring treatment 5. Acute coronary syndrome/acute myocardial infarction, unstable angina ± coronary intervention with Percutaneous Coronary Intervention, or Coronary Artery Bypass Grafting 6. Heart failure 7. History of organ transplantation or is likely to receive lung transplantation

Interventions

OTHER

Placebo for AZD8965

DRUG

AZD8965 low dose

DRUG

AZD8965 medium dose

DRUG

AZD8965 high dose

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Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Locations

Research Site

Birmingham, Alabama 35205

United States

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Phoenix, Arizona 85006

United States

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Phoenix, Arizona 85032

United States

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Loma Linda, California 92350

United States

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Los Angeles, California 90033

United States

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Newport Beach, California 92663

United States

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Sacramento, California 95817

United States

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Stanford, California 94305

United States

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Aurora, Colorado 80045

United States

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Denver, Colorado 80206

United States

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Ocala, Florida 34470

United States

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Weston, Florida 33331

United States

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Atlanta, Georgia 30322

United States

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Boise, Idaho 83712

United States

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Champaign, Illinois 61820

United States

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Chicago, Illinois 60611

United States

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Kansas City, Kansas 66160

United States

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Lexington, Kentucky 40536

United States

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Baltimore, Maryland 21201

United States

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Boston, Massachusetts 02114

United States

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Ann Arbor, Michigan 48109

United States

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Detroit, Michigan 48202

United States

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New York, New York 10017

United States

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New York, New York 10029

United States

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Greensboro, North Carolina 27403

United States

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Cincinnati, Ohio 45267

United States

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Oklahoma City, Oklahoma 73117

United States

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Bethlehem, Pennsylvania 18015

United States

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Philadelphia, Pennsylvania 19104

United States

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Philadelphia, Pennsylvania 19140

United States

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Charleston, South Carolina 29425

United States

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Dallas, Texas 75254

United States

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El Paso, Texas 79902

United States

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Houston, Texas 77030

United States

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Burlington, Vermont 05401

United States

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Richmond, Virginia 23298

United States

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Alberdi, X5033DCE

Argentina

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Buenos Aires, 1425

Argentina

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Ciudad de Buenos Aires, C1414AIF

Argentina

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Florida, B1602DQD

Argentina

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Rosario, 2000

Argentina

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San Fernando, B1646EBJ

Argentina

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Port Macquarie, 2444

Australia

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Wollongong, 2500

Australia

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Haskovo, 6300

Bulgaria

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Plovdiv, 4001

Bulgaria

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Rousse, 7000

Bulgaria

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Sofia, 1618

Bulgaria

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Sofia, 1680

Bulgaria

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Sofia, 1756

Bulgaria

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Sherwood Park, Alberta T8H 2M7

Canada

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Vancouver, British Columbia V5Z 1M9

Canada

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Ajax, Ontario L1S 2J5

Canada

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Burlington, Ontario L7N 3V2

Canada

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Kingston, Ontario K7M 4E7

Canada

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North York, Ontario M2K 1E1

Canada

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Saint-Charles-Borromée, Quebec J6E 2B4

Canada

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Sherbrooke, Quebec J1H 5N4

Canada

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Providencia, 7500504

Chile

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Santiago, 7750495

Chile

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Talca, 3481349

Chile

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Viña del Mar, 2531172

Chile

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Viña del Mar, 2540488

Chile

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Beijing, 100000

China

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Beijing, 100029

China

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Beijing, 100730

China

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Changchun, 130041

China

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Changsha, 430033

China

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Chengdu, 610041

China

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Chengdu, 610078

China

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Guangzhou, 510735

China

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Lanzhou, 730030

China

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Nanchang, 330000

China

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Nanjing, 2100008

China

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Shanghai, 200433

China

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Shenyang, 110015

China

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Wuhan, 430048

China

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Xuzhou, 221000

China

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Zhengzhou, 450000

China

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Aarhus, 8200

Denmark

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Copenhagen, 2100

Denmark

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Hellerup, 2900

Denmark

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Odense C, 5000

Denmark

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Angers, 49933

France

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Brest, 29609

France

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Bron, 69677

France

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Montpellier, 34295

France

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Nice, 6000

France

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Paris, 75877

France

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Rennes, 35033

France

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Tours, 37000

France

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Bonn, 53127

Germany

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Essen, 45239

Germany

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Freiburg im Breisgau, 79106

Germany

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Fulda, 36043

Germany

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Giessen, 35392

Germany

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Hamburg, 20251

Germany

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Hanover, 30459

Germany

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Heidelberg, 69126

Germany

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Hemer, 58675

Germany

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Konstanz, 78464

Germany

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Leipzig, 04103

Germany

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Lübeck, 23538

Germany

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Marburg, 35037

Germany

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Munich, 81377

Germany

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Stuttgart, 70376

Germany

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Witten, 58452

Germany

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Wuppertal-Barmen, 42283

Germany

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Athens, 11527

Greece

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Athens, 12462

Greece

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Heraklion, 71110

Greece

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Ioannina, 45500

Greece

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Pátrai, 26500

Greece

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Thessaloniki, 57010

Greece

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Budapest, 1083

Hungary

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Budapest, 1121

Hungary

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Debrecen, 4032

Hungary

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Törökbálint, 2045

Hungary

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Ashkelon, 78278

Israel

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Jerusalem, 9103102

Israel

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Kfar Saba, 4428164

Israel

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Petah Tikva, 4941492

Israel

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Rehovot, 76100

Israel

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Foggia, 71100

Italy

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Forlì, 47121

Italy

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Modena, 41124

Italy

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Monza, 20900

Italy

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Pavia, 27100

Italy

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Rozzano, 20089

Italy

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Siena, 53100

Italy

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Torino, 10126

Italy

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Fukuoka, 810-8563

Japan

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Hachioji-shi, 193-0998

Japan

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Hamamatsu, 431-3192

Japan

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Hiroshima, 734-8530

Japan

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Kakogawa-shi, 675-8611

Japan

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Kumagaya-shi, 360-0197

Japan

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Kumamoto, 861-4193

Japan

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Matsusaka-shi, 515-8544

Japan

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Sakaishi, 591-8555

Japan

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Sendai, 980-8574

Japan

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Seto-shi, 489-8642

Japan

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Shimotsuke-shi, 329-0498

Japan

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Shinjuku-ku, 162-8655

Japan

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Yokohama, 236-0037

Japan

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Yokohama, 236-0051

Japan

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Benito Juárez, 03330

Mexico

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Chihuahua City, 31203

Mexico

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Coyocan, 04330

Mexico

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León, 37160

Mexico

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Mérida, 97130

Mexico

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Monterrey, 64460

Mexico

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Monterrey, 64465

Mexico

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Oaxaca City, 68000

Mexico

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Pachuca, 42070

Mexico

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Bialystok, 15-044

Poland

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Krakow, 31-202

Poland

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Lodz, 90-153

Poland

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Poznan, 60-569

Poland

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Rzeszów, 35-205

Poland

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Warsaw, 02-507

Poland

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Cape Town, 7700

South Africa

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Durban, 4001

South Africa

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Parktown West, 2193

South Africa

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Somerset West, 7130

South Africa

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Seongnam-si, 13620

South Korea

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Seoul, 02841

South Korea

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Seoul, 04401

South Korea

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Seoul, 06351

South Korea

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Seoul, 5505

South Korea

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Barcelona, 08036

Spain

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Barcelona, 8025

Spain

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L'Hospitalet de Llobregat, 08907

Spain

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Madrid, 28006

Spain

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Málaga, 29010

Spain

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Valencia, 46010

Spain

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 824

Taiwan

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Taichung, 40705

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 11220

Taiwan

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Taipei, 11696

Taiwan

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Taoyuan, 333

Taiwan

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Yunlin, 640

Taiwan

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Bristol, BS105NB

United Kingdom

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Cottingham, HU16 5JQ

United Kingdom

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Edinburgh, EH16 4SA

United Kingdom

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Exeter, EX2 5DW

United Kingdom

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Liverpool, L9 7AL

United Kingdom

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London, SW3 6NP

United Kingdom