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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
NCT07662213 · AstraZeneca
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Oral Semaglutide in Adults With Type 2 Diabetes Mellitus (Eluminate-2)
About this study
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
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
Study design
Enrollment target: 1200 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-07-06
Estimated completion: 2028-05-23
Last updated: 2026-07-14
Interventions
Drug: ElecoglipronDrug: Semaglutide
Primary outcomes
- • Change from baseline in Hemoglobin A1c (HbA1c) (Baseline to Week 52)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (201)
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Birmingham, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Covina, California, United States
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Encinitas, California, United States
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Garden Grove, California, United States
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Loma Linda, California, United States
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Long Beach, California, United States
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Pomona, California, United States
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Sacramento, California, United States
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Bridgeport, Connecticut, United States
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Crystal River, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Leesburg, Florida, United States
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Orlando, Florida, United States
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Lilburn, Georgia, United States
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Idaho Falls, Idaho, United States
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Melrose Park, Illinois, United States
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Evansville, Indiana, United States
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Ames, Iowa, United States
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Wichita, Kansas, United States
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Bowling Green, Kentucky, United States
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Rockville, Maryland, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Jefferson City, Missouri, United States
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Kansas City, Missouri, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Albuquerque, New Mexico, United States
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Durham, North Carolina, United States
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Morehead City, North Carolina, United States
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Raleigh, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Columbus, Ohio, United States
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Yukon, Oklahoma, United States
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Feasterville-Trevose, Pennsylvania, United States
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Philadelphia, Pennsylvania, 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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Memphis, Tennessee, United States
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Morristown, Tennessee, United States
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Dallas, 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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Katy, 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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Weslaco, Texas, United States
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Bountiful, Utah, United States
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Salt Lake City, Utah, United States
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Leesburg, Virginia, United States
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Norfolk, Virginia, United States
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Renton, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Buenos Aires, Argentina
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CABA, Argentina
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Caba, Argentina
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Ciudad de Buenos Aires, Argentina
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Rosario, Argentina
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San Nicolás, Argentina
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San Vicente, Argentina
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Botany, Australia
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East Toowoomba, Australia
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Fitzroy, Australia
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Heidelberg Heights, Australia
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Kingswood, Australia
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Melbourne, Australia
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Parkville, Australia
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St Leonards, Australia
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Brasília, Brazil
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Campinas, Brazil
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Curitiba, Brazil
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Natal, Brazil
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Porto Alegre, Brazil
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São José dos Campos, Brazil
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São Paulo, Brazil
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Yambol, Bulgaria
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Vancouver, British Columbia, Canada
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Guelph, Ontario, Canada
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Sarnia, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Stouffville, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Changsha, China
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Changsha, China
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Hefei, China
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Hefei, China
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Huai'an, China
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Langfang, China
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Liangyugang, China
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Luoyang, China
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Nanjing, China
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Nanyang, China
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Pinggu, China
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Pingxiang, China
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Shijiazhuang, China
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Tianjin, China
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Yueyang, China
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Bad Oeynhausen, Germany
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Berlin, Germany
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Chemnitz, Germany
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Damme, Germany
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Duisburg, Germany
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Elsterwerda, Germany
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Erlangen, Germany
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Essen, Germany
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Falkensee, Germany
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Gladbeck, Germany
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Hamburg, Germany
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Hamburg, Germany
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Leipzig, Germany
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Mannheim, Germany
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Münster, Germany
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Oldenburg, Germany
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Pirna, Germany
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Sankt Ingbert, Germany
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Wangen, Germany
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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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Salgótarján, Hungary
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Szeged, Hungary
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Szolnok, Hungary
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Zalaegerszeg, Hungary
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Bari, Italy
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Bologna, Italy
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Chieti, Italy
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Milan, Italy
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Milan, Italy
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Modena, Italy
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Naples, Italy
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Roma, Italy
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Roma, Italy
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Asahikawa-shi, Japan
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Chūōku, Japan
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Kamakura-shi, Japan
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Koga-shi, Japan
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Mitaka-shi, Japan
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Mito, Japan
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Miyazaki, Japan
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Nagoya, Japan
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Nagoya, Japan
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Naka, Japan
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Naka, Japan
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Nishinomiya-shi, Japan
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Sapporo, Japan
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Takamatsu, Japan
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Bialystok, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Poznan, Poland
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Radom, Poland
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Warsaw, Poland
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Warsaw, Poland
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Daegu, South Korea
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Daejeon, South Korea
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Guri-si, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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New Taipei City, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Yung Kang City, Taiwan
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Aberdeen, United Kingdom
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Addlestone, United Kingdom
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Banbury, United Kingdom
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Bristol, United Kingdom
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Bristol, United Kingdom
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Edinburgh, United Kingdom
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Hounslow, United Kingdom
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Penzance, United Kingdom
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Poole, United Kingdom
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Soham, United Kingdom
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Wansford, United Kingdom
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Yate, United Kingdom