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NCT07662213PHASE3Recruiting

A Study to Find Out if the Study Drug Elecoglipron Helps Adults With Type 2 Diabetes Mellitus by Comparing it With Semaglutide, a Medicine Already Used to Treat Type 2 Diabetes Mellitus

AstraZeneca

Start Date

7/6/2026

Completion Date

5/23/2028

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening * T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication(s) * HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) * Increased risk of cardiovascular (CV) events defined by ≥1 of: documented coronary heart disease, peripheral arterial disease, ischemic cerebrovascular disease, or heart failure (NYHA II-III); or ≥2 CV risk factors * Body mass index (BMI) of ≥ 23 kg/m2 at screening * Stable body weight (self-reported or documented) for 90 days prior to screening Exclusion Criteria: * Type 1 Diabetes Mellitus (T1DM), secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma * Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema * Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms * Clinically significant condition affecting the upper Gastrointestinal (GI) tract or chronic use of any medication that affects gastric motility or gastric emptying * History of acute or chronic pancreatitis * Severe congestive heart failure (NYHA IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Interventions

DRUG

Elecoglipron

DRUG

Semaglutide

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Conditions

Type 2 Diabetes Mellitus

Locations

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Birmingham, Alabama 35205

United States

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Mesa, Arizona 85213

United States

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Phoenix, Arizona 85016

United States

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Tempe, Arizona 85281

United States

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Covina, California 91723

United States

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Encinitas, California 92024

United States

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Garden Grove, California 92844

United States

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Loma Linda, California 92350

United States

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Long Beach, California 90807

United States

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Pomona, California 91768

United States

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Sacramento, California 95821

United States

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Bridgeport, Connecticut 06606

United States

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Crystal River, Florida 34429

United States

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Hollywood, Florida 33021

United States

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Jacksonville, Florida 32209

United States

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Leesburg, Florida 34748

United States

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Orlando, Florida 32806

United States

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Lilburn, Georgia 30047

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Idaho Falls, Idaho 83404

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Melrose Park, Illinois 60160

United States

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Evansville, Indiana 47710

United States

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Ames, Iowa 50010

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Wichita, Kansas 67226

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Bowling Green, Kentucky 42101

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Rockville, Maryland 20852

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Southfield, Michigan 48076

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Minneapolis, Minnesota 55416

United States

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Jefferson City, Missouri 65109

United States

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Kansas City, Missouri 64114

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Omaha, Nebraska 68114

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Henderson, Nevada 89052

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Las Vegas, Nevada 89128

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Albuquerque, New Mexico 87112

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Durham, North Carolina 27701

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Morehead City, North Carolina 28557

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Raleigh, North Carolina 27612

United States

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Statesville, North Carolina 28625

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Wilmington, North Carolina 28403

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Columbus, Ohio 43215

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Yukon, Oklahoma 73099

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Feasterville-Trevose, Pennsylvania 19053

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Philadelphia, Pennsylvania 19114

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Myrtle Beach, South Carolina 29572

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North Charleston, South Carolina 29405

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Memphis, Tennessee 38119

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Morristown, Tennessee 37813

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Dallas, Texas 75390

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Houston, Texas 77004

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Houston, Texas 77040

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Houston, Texas 77079

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Katy, Texas 77450

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San Antonio, Texas 78229

United States

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San Antonio, Texas 78231

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Sugar Land, Texas 77478

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Weslaco, Texas 78596

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Bountiful, Utah 84010

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Salt Lake City, Utah 84124

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Leesburg, Virginia 20176

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Norfolk, Virginia 23502

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Renton, Washington 98057

United States

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Seattle, Washington 98104

United States

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Seattle, Washington 98105

United States

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Morgantown, West Virginia 26505

United States

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Buenos Aires, C1425AGC

Argentina

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CABA, C1120AAC

Argentina

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Caba, C1128AAF

Argentina

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Ciudad de Buenos Aires, C1094AAD

Argentina

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Rosario, S2000CVD

Argentina

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San Nicolás, B2900DMH

Argentina

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San Vicente, 5006

Argentina

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Botany, 2019

Australia

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East Toowoomba, 4350

Australia

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Fitzroy, 3065

Australia

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Heidelberg Heights, 3081

Australia

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Kingswood, 2747

Australia

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Melbourne, 3004

Australia

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Parkville, 3050

Australia

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St Leonards, 2065

Australia

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Brasília, 71625-009

Brazil

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Campinas, 13060-904

Brazil

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Curitiba, 80030-480

Brazil

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Natal, 59020-035

Brazil

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Porto Alegre, 90630-165

Brazil

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São José dos Campos, 12243-280

Brazil

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São Paulo, 04012-180

Brazil

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Plovdiv, 4001

Bulgaria

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Sofia, 1407

Bulgaria

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Sofia, 1618

Bulgaria

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Sofia, 1700

Bulgaria

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Yambol, 8600

Bulgaria

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Vancouver, British Columbia V5Y 3W2

Canada

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Guelph, Ontario N1H 1B1

Canada

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Sarnia, Ontario N7T 4X3

Canada

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Scarborough Village, Ontario M1R 0B1

Canada

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Stouffville, Ontario L4A1H2

Canada

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Toronto, Ontario M4G3E8

Canada

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Toronto, Ontario M6G 1M2

Canada

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Toronto, Ontario M9V 4B4

Canada

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Montreal, Quebec H4N 2W2

Canada

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Saint-Charles-Borromée, Quebec J6E 2B4

Canada

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Changsha, 410013

China

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Changsha, 410015

China

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Hefei, 230000

China

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Hefei, 230601

China

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Huai'an, 223005

China

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Langfang, 065000

China

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Liangyugang, 222002

China

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Luoyang, 471009

China

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Nanjing, 2100008

China

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Nanyang, 473009

China

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Pinggu, 101200

China

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Pingxiang, 337055

China

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Shijiazhuang, 050000

China

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Tianjin, 300134

China

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Yueyang, 414000

China

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Bad Oeynhausen, 32545

Germany

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Berlin, 13597

Germany

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Chemnitz, 09116

Germany

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Damme, 49401

Germany

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Duisburg, 47051

Germany

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Elsterwerda, 04910

Germany

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Erlangen, 91054

Germany

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Essen, 45359

Germany

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Falkensee, 14612

Germany

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Gladbeck, 45968

Germany

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Hamburg, 21109

Germany

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Hamburg, 22607

Germany

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Leipzig, 04249

Germany

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Mannheim, 68167

Germany

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Münster, 48145

Germany

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Oldenburg, 23758

Germany

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Pirna, 01796

Germany

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Sankt Ingbert, 66386

Germany

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Wangen, 88239

Germany

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Budapest, 1036

Hungary

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Budapest, 1089

Hungary

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Budapest, 1132

Hungary

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Debrecen, 4032

Hungary

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Salgótarján, 3100

Hungary

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Szeged, 6725

Hungary

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Szolnok, 5000

Hungary

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Zalaegerszeg, 8900

Hungary

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Bari, 70124

Italy

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Bologna, 40138

Italy

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Chieti, 66100

Italy

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Milan, 20132

Italy

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Milan, 20138

Italy

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Modena, 41100

Italy

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Naples, 80138

Italy

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Roma, 00161

Italy

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Roma, 00168

Italy

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Asahikawa-shi, 070-8530

Japan

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Chūōku, 103-0002

Japan

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Kamakura-shi, 247-0056

Japan

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Koga-shi, 306-0232

Japan

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Mitaka-shi, 181-0013

Japan

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Mito, 310-0826

Japan

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Miyazaki, 880-0034

Japan

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Nagoya, 467-8602

Japan

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Nagoya, 468-0009

Japan

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Naka, 311-0113

Japan

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Naka, 311-0133

Japan

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Nishinomiya-shi, 663-8113

Japan

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Sapporo, 062-0007

Japan

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Takamatsu, 760-0018

Japan

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Bialystok, 15-897

Poland

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Krakow, 31-261

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Lodz, 90-338

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Lublin, 20-718

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Poznan, 60-354

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Radom, 26-600

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Warsaw, 00-124

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Warsaw, 02-507

Poland

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Daegu, 41404

South Korea

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Daejeon, 35015

South Korea

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Guri-si, 11923

South Korea

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Incheon, 21565

South Korea

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Seoul, 05278

South Korea

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Seoul, 06351

South Korea

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Changhua, 50006

Taiwan

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Kaohsiung City, 81362

Taiwan

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New Taipei City, 220

Taiwan

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Taichung, 40201

Taiwan

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Taichung, 40705

Taiwan

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Taichung, 433004

Taiwan

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Tainan, 704

Taiwan

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Taipei, 10002

Taiwan

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Taoyuan, 333

Taiwan

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Yung Kang City, 71044

Taiwan

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Aberdeen, AB25 2ZN

United Kingdom

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Addlestone, KT15 2BH

United Kingdom

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Banbury, OX16 9AD

United Kingdom

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Bristol, BS34 5TF

United Kingdom

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Bristol, BS34 6BQ

United Kingdom

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Edinburgh, EH4 2XU

United Kingdom

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Hounslow, TW3 3LN

United Kingdom

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Penzance, TR18 3DX

United Kingdom

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Poole, BH16 5PW

United Kingdom

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Soham, CB7 5JD

United Kingdom

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Wansford, PE8 6PL

United Kingdom

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Yate, BS37 4AX

United Kingdom