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NCT07662109PHASE3Recruiting

A Phase III Study to Investigate the Efficacy and Safety of the Combination of Elecoglipron and Dapagliflozin in Adults With Type 2 Diabetes Mellitus

AstraZeneca

Start Date

7/6/2026

Completion Date

7/5/2028

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron and dapagliflozin in combination, compared with elecoglipron alone and dapagliflozin alone, in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

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 * HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol) * 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, 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 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 (New York Heart Association IV) * History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Interventions

DRUG

Elecoglipron

DRUG

Dapagliflozin

DRUG

Elecoglipron-matched placebo

DRUG

Dapagliflozin-matched placebo

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Conditions

Type 2 Diabetes Mellitus

Locations

Research Site

Huntsville, Alabama 35801

United States

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Mobile, Alabama 36608

United States

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Sheffield, Alabama 35660

United States

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Little Rock, Arkansas 72205

United States

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Bakersfield, California 93309

United States

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Los Angeles, California 90017

United States

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Ontario, California 91762

United States

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Lake City, Florida 32055

United States

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Lakeland, Florida 33813

United States

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Atlanta, Georgia 30315

United States

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Chicago, Illinois 60640

United States

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Skokie, Illinois 60077

United States

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Evansville, Indiana 47714

United States

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Sioux City, Iowa 51106

United States

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Zachary, Louisiana 70791

United States

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Annapolis, Maryland 21401

United States

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Lutherville-Timonium, Maryland 21093

United States

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Oxon Hill, Maryland 20745

United States

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Boston, Massachusetts 02114

United States

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Boston, Massachusetts 02115

United States

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Troy, Michigan 48098

United States

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Ridgeland, Mississippi 39157

United States

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Elkhorn, Nebraska 68022

United States

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Albuquerque, New Mexico 87112

United States

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Brooklyn, New York 11201

United States

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Raleigh, North Carolina 27607

United States

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Beachwood, Ohio 44122

United States

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Maumee, Ohio 43537

United States

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Norman, Oklahoma 73069

United States

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Kingsport, Tennessee 37660

United States

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Nashville, Tennessee 37203

United States

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Dallas, Texas 75230

United States

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McKinney, Texas 75069

United States

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Paris, Texas 75462

United States

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San Antonio, Texas 78229

United States

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South Jordan, Utah 84095

United States

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Arlington, Virginia 22205

United States

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Newport News, Virginia 23606

United States

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Redmond, Washington 98052

United States

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Kingwood, West Virginia 26537

United States

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Buenos Aires, C1012AAR

Argentina

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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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Mar del Plata, B7600GNY

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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Barretos, 14784-400

Brazil

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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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Fortaleza, 60430-350

Brazil

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Natal, 59020-035

Brazil

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Porto Alegre, 90630-165

Brazil

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Rio de Janeiro, 22270-060

Brazil

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São José dos Campos, 12243-280

Brazil

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São Paulo, 01228-200

Brazil

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São Paulo, 04012-180

Brazil

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Baotou,

China

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Beijing, 100044

China

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Beijing, 100050

China

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Beijing, 102218

China

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Changde, 415000

China

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Changsha, 410015

China

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Changzhou, 272100

China

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Chengdu, 610078

China

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Chengdu, 611130

China

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Chenzhou, 423000

China

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Chifeng, 024000

China

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Hangzhou, 310014

China

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Hefei, 230601

China

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Huai'an, 223005

China

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Jinan, 250031

China

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Jincheng, 048000

China

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Jining, 272006

China

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Jinzhou Shi, 121001

China

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Kaifeng, 475000

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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Meihekou, 135022

China

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Nanjing, 210011

China

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Nantong, 226001

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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Sanya, 572000

China

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Shanghai, 200062

China

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Shanghai, 201199

China

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Shantou, 515065

China

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Shenyang, 110004

China

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Shenyang, 110023

China

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Shijiazhuang, 050000

China

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Shijiazhuang, 050001

China

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Tianjin, 300000

China

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Wuhan, 430010

China

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Wuhu, 241004

China

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Xi'an, 710077

China

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Xiangyang, 441000

China

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Xianyang, 712000

China

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Xuzhou, 221000

China

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Xuzhou, 221009

China

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Yan’an, 716000

China

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Yueyang, 414000

China

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Zhumadian, 463000

China

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Zibo, 255499

China

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Hradec Králové, 500 02

Czechia

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Humpolec, 396 01

Czechia

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Jílové u Prahy, 254 01

Czechia

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Ostrava, 702 00

Czechia

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Prague, 147 00

Czechia

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Prague, 149 00

Czechia

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Prague, 160 00

Czechia

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Příbram, 261 01

Czechia

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Aarhus N, 8200

Denmark

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Esbjerg, 6700

Denmark

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Gandrup, 9362

Denmark

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Herlev, 2730

Denmark

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Hillerød, 3400

Denmark

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Hvidovre, 2650

Denmark

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Odense, 5000

Denmark

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Berlin, 13597

Germany

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Cologne, 51069

Germany

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Damme, 49401

Germany

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Deggingen, 73326

Germany

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Duisburg, 47269

Germany

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Essen, 45355

Germany

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Falkensee, 14612

Germany

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Frankfurt, 60596

Germany

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Hamburg, 22607

Germany

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Leipzig, 04249

Germany

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Münster, 48145

Germany

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Nittendorf, 93152

Germany

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Pohlheim, 35415

Germany

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Villingen-Schwenningen, 78048

Germany

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Wallerfing, 94574

Germany

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Weinheim, 69469

Germany

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Alexandroupoli, 68100

Greece

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Athens, 115 25

Greece

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Athens, 11527

Greece

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Athens, 17562

Greece

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Ioannina, 45500

Greece

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Thessaloniki, 54635

Greece

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Thessaloniki, 54642

Greece

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Thessaloniki, 54645

Greece

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Budapest, 1036

Hungary

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Budapest, 1089

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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Bangalore, 560 092

India

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Belagavi, 590006

India

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Belagavi, 590010

India

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Calicut, 673008

India

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Chennai, 600086

India

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Coimbatore, 641018

India

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Guwahati, 781032

India

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Indore, 452008

India

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Jaipur, 302017

India

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Kochi, 682040

India

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Kochi, 682041

India

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Lucknow, 226030

India

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Madurai, 625020

India

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Mumbai, 400012

India

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Nagpur, 440010

India

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New Delhi, 11029

India

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Thiruvananthapuram, 695031

India

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Chūōku, 103-0027

Japan

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Hachioji-shi, 192-0083

Japan

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Ichikawa-shi, 272-8516

Japan

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Kishiwada-shi, 596-8501

Japan

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Meguro-ku, 153-0053

Japan

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Mito, 310-0826

Japan

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Sapporo, 060-0061

Japan

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Shinjuku-ku, 160-0008

Japan

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Yamato-shi, 242-0004

Japan

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Alor Star, 05400

Malaysia

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Ipoh, 30450

Malaysia

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Kangar, 01000

Malaysia

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Kuala Lumpur, 59100

Malaysia

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Sarawak Miri, 98000

Malaysia

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Seremban, 70300

Malaysia

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Seri Manjung, 32040

Malaysia

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Cuernavaca, 62448

Mexico

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Bialystok, 15-897

Poland

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Częstochowa, 42-217

Poland

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Kielce, 25-355

Poland

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Lodz, 90-338

Poland

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Lublin, 20-718

Poland

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Poznan, 60-354

Poland

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Radom, 26-600

Poland

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Warsaw, 00-124

Poland

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Warsaw, 02-507

Poland

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San Juan, 00918

Puerto Rico

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Brackenfell, 7560

South Africa

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Cape Town, 7500

South Africa

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Cape Town, 7570

South Africa

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Claremont, 7708

South Africa

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Durban, 4091

South Africa

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Durban, 4093

South Africa

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eMkhomazi, 4170

South Africa

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Johannesburg, 1827

South Africa

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KwaDukuza, 4449

South Africa

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Paarl, 7646

South Africa

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Pretoria,

South Africa

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Goyang-si, 411-706

South Korea

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Guri-si, 11923

South Korea

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Gwangju, 61453

South Korea

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Gyeonggi-do, 13620

South Korea

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Seoul, 03722

South Korea

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Seoul, 06273

South Korea

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Seoul, 136-705

South Korea

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Yangsan, 50612

South Korea

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Changhua, 500

Taiwan

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 813

Taiwan

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New Taipei City, 220

Taiwan

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New Taipei City, 24352

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, 70403

Taiwan

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Tainan County, 71044

Taiwan

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Taipei, 10002

Taiwan

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Taoyuan, 333

Taiwan

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Bangkok, 10400

Thailand

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Banphaeo, 74120

Thailand

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Changwat Sara Buri, 18000

Thailand

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Khlong Luang, 12120

Thailand

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Khon Kaen, 40002

Thailand

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Muang, 70000

Thailand

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Mueang, 20000

Thailand

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Ratchathewi, 10400

Thailand

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Ankara, 06540

Turkey (Türkiye)

Research Site

Ankara, 6200

Turkey (Türkiye)

Research Site

Gaziantep, 27470

Turkey (Türkiye)

Research Site

Istanbul, 34010

Turkey (Türkiye)

Research Site

Istanbul, 34265

Turkey (Türkiye)

Research Site

Istanbul, 34384

Turkey (Türkiye)

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Konya, 42130

Turkey (Türkiye)

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Kyiv, 02002

Ukraine

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Kyiv, 03037

Ukraine

Research Site

Kyiv, 03049

Ukraine

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Kyiv, 03057

Ukraine

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Kyiv, 04114

Ukraine

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Kyiv, 04210

Ukraine

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Lviv, 79010

Ukraine

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Lviv, 79016

Ukraine

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Uzhhorod, 88002

Ukraine

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Uzhhorod, 88014

Ukraine

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Vinnytsia, 21001

Ukraine

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Blackburn, BB2 1AX

United Kingdom

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Dundee, DD1 9SY

United Kingdom

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Guisborough, TS14 7DJ

United Kingdom

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Nantwich, CW5 5NX

United Kingdom

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Rotherham, S65 1DA

United Kingdom

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Thetford, IP24 1JD

United Kingdom

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Weston-super-Mare, BS24 7PR

United Kingdom

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Witney, OX28 6JS

United Kingdom

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Woodbridge, IP136TH

United Kingdom

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Yate, BS37 4AX

United Kingdom

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Hanoi, 10000

Vietnam

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Ho Chi Minh City, 700000

Vietnam

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Hochiminh City, 700000

Vietnam

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Hochiminh, 700000

Vietnam

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Hồ Chí Minh, 700000

Vietnam

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Huế, 530000

Vietnam

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Rach Gia, 920000

Vietnam