A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
NCT ID: NCT07082738
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
1160 participants
INTERVENTIONAL
2025-06-27
2027-11-05
Brief Summary
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Detailed Description
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Approximately 400 sites globally will participate in this study. Approximately 1160 participants will be randomized to four treatment groups; three different doses of AZD6793 vs placebo in a 1:1:1:1 ratio.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose 1 of AZD6793
Approximately 290 participants will be randomized to receive Dose 1 of AZD6793
AZD6793
Oral dosage
Dose 2 of AZD6793
Approximately 290 participants will be randomized to receive Dose 2 of AZD6793
AZD6793
Oral dosage
Dose 3 of AZD6793
Approximately 290 participants will be randomized to receive Dose 3 of AZD6793
AZD6793
Oral dosage
Matching Placebo
Approximately 290 participants will be randomized to receive Matching Placebo
Placebo
Oral dosage
Interventions
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AZD6793
Oral dosage
Placebo
Oral dosage
Eligibility Criteria
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Inclusion Criteria
* Documented primary diagnosis of moderate to very severe COPD for at least 12 months prior to enrolment.
* Pre-BD FEV1/FVC \< 0.7 at Visit 1 and pre- and post-BD FEV1/FVC \< 0.7, and post-BD FEV1 ≥ 25% to \< 80% of predicted normal at Visit 2.
* Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening.
* Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening.
* CAT score ≥ 10 at Visit 1.
* Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years.
* Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and remain exacerbation free at Visit 3 (randomisation).
* Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
Exclusion Criteria
* Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.
* Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.
* Significant left heart failure.
* Unstable angina, acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention/coronary artery bypass graft within 6 months of randomisation, uncontrolled arrhythmia, or cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary oedema or volume overload.
* Pulmonary arterial hypertension, either idiopathic or due to connective tissue or thromboembolic disease.
* History of another underlying condition that predisposes the participant to infections.
* History of ulcerative colitis, Crohn's disease, or microscopic colitis diagnosed by either a gastroenterologist or by histopathology.
* Abnormal laboratory findings.
* Participants with evidence of active liver disease and/or evidence of chronic liver disease.
* Participants with history of HIV infection or who test positive for HIV.
* History of lung volume reduction surgery.
* Current or history of malignancy within 5 years before the screening visit.
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Dave Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Medicines Evaluation Unit, Manchester University NHS Foundations Trust, Manchester, United Kingdom
Locations
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Birmingham, Alabama, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Canoga Park, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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Norco, California, United States
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Tustin, California, United States
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Lakewood, Colorado, United States
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Brandon, Florida, United States
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Cape Coral, Florida, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Jacksonville, Florida, United States
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Lake City, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Naples, Florida, United States
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Ocala, Florida, United States
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Ormond Beach, Florida, United States
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Plantation, Florida, United States
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Sarasota, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Suwanee, Georgia, United States
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West Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Zachary, Louisiana, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Burlington, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Garden City, Michigan, United States
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Grand Rapids, Michigan, United States
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Chesterfield, Missouri, United States
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Hannibal, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Mount Kisco, New York, United States
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New Bern, North Carolina, United States
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Cleveland, Ohio, United States
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Marion, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Camp Hill, Pennsylvania, United States
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DuBois, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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Lancaster, South Carolina, United States
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Spartanburg, South Carolina, United States
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Rapid City, South Dakota, United States
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Chattanooga, Tennessee, United States
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Franklin, Tennessee, United States
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Johnson City, Tennessee, United States
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Boerne, Texas, United States
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Dallas, Texas, United States
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Denison, Texas, United States
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El Paso, 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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Kingwood, Texas, United States
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Lewisville, Texas, United States
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Mansfield, Texas, United States
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McKinney, Texas, United States
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Pearland, Texas, United States
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Colchester, Vermont, United States
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Norfolk, Virginia, United States
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Williamsburg, Virginia, United States
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Morgantown, West Virginia, United States
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Madison, Wisconsin, United States
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Alberdi, , Argentina
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CABA, , Argentina
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Capital Federal, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Mar del Plata, , Argentina
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Mar del Plata, , Argentina
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Mendoza, , Argentina
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Ranelagh, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Cairns, , Australia
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Norwood, , Australia
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Osborne Park, , Australia
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South Brisbane, , Australia
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Wollongong, , Australia
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Dupnitsa, , Bulgaria
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Haskovo, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Stara Zagora, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Yambol, , Bulgaria
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Edmonton, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Truro, Nova Scotia, Canada
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Ajax, Ontario, Canada
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Burlington, Ontario, Canada
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Guelph, Ontario, Canada
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Hamilton, Ontario, Canada
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Stoney Creek, Ontario, Canada
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Québec, Quebec, Canada
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Saint-Charles-Borromée, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Victoriaville, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Chile, , Chile
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Concepción, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Talca, , Chile
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Temuco, , Chile
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Viña del Mar, , Chile
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Baotou, , 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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Changsha, , China
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Chengdu, , China
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Chengdu, , China
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Chengdu, , China
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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hohhot, , China
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Jinan, , China
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Kunming, , China
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Linhai, , China
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Nanchang, , China
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Nanjing, , China
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Nanning, , China
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Qingdao, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Wuhan, , China
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Wuhan, , China
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Xuzhou, , China
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Zhengzhou, , China
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Aalborg, , Denmark
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Aarhus, , Denmark
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Esbjerg, , Denmark
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Hvidovre, , Denmark
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Odense C, , Denmark
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Roskilde, , Denmark
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Ahrensburg, , Germany
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Bendorf, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Darmstadt, , Germany
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Halle, , Germany
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Hanover, , Germany
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Landsberg, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Marburg, , Germany
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Obertshausen, , Germany
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Rosenheim, , Germany
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Schleswig, , Germany
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Wiesbaden, , Germany
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Witten, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Ioannina, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Budapest, , Hungary
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Debrecen, , Hungary
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Edelény, , Hungary
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Encs, , Hungary
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Gödöllő, , Hungary
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Hajdúnánás, , Hungary
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Nyíregyháza-Sóstóhegy, , Hungary
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Törökbálint, , Hungary
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Belagavi, , India
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Coimbatore, , India
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Dehradun, , India
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Dwārka, , India
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Hyderabad, , India
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Hyderabad, , India
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Kochi, , India
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Mumbai, , India
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Nagpur, , India
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Vijayawada, , India
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Busto Arsizio, , Italy
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Cuneo, , Italy
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Milan, , Italy
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Monza, , Italy
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Napoli, , Italy
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Pavia, , Italy
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Roma, , Italy
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Statte, , Italy
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Telese Terme, , Italy
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Chiba, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Ginowan-shi, , Japan
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Hachioji-shi, , Japan
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Hamamatsu, , Japan
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Hiroshima, , Japan
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Izumi-shi, , Japan
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Kamakura, , Japan
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Kanazawa, , Japan
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Kasuga-shi, , Japan
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Kawasaki-shi, , Japan
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Kiyosu-shi, , Japan
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Kochi, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kyoto, , Japan
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Maebashi, , Japan
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Matsuyama, , Japan
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Minoh, , Japan
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Minokamo Shi, , Japan
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Mizunami-shi, , Japan
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Osaka, , Japan
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Ōita, , Japan
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Sagamihara-shi, , Japan
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Sapporo, , Japan
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Sasebo-shi, , Japan
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Shimotsuga-gun, , Japan
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Shinjuku-ku, , Japan
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Tachikawa-shi, , Japan
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Toon-shi, , Japan
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Toyota, , Japan
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Ube, , Japan
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Yokkaichi-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Chihuahua City, , Mexico
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Durango, , Mexico
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Guadalajara, , Mexico
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Guadalajara, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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Monterrey, , Mexico
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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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Lima, , Peru
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Chęciny, , Poland
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Elblag, , Poland
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Karczew, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Komorniki, , Poland
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Ksawerów, , Poland
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Lodz, , Poland
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Ostróda, , Poland
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Piaseczno, , Poland
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Piaseczno, , Poland
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Poznan, , Poland
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Płock, , Poland
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Rzeszów, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Anyang-si, , South Korea
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Cheongju-si, , South Korea
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Chuncheon, , South Korea
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Daegu, , South Korea
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Daegu, , South Korea
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Jeonju, , 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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Seoul, , South Korea
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Wŏnju, , South Korea
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Benalmádena, , Spain
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Granollers, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Mérida, , Spain
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Pozuelo de Alarcón, , Spain
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Santander, , Spain
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Changhua, , Taiwan
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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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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Yung Kang City, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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İzmit, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Chernivtsi, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Bradford, , United Kingdom
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Cottingham, , United Kingdom
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Glasgow, , United Kingdom
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Harrow, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Thetford, , United Kingdom
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Wythenshawe, , United Kingdom
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Da Nang, , Vietnam
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Dong Thập, , Vietnam
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Hanoi, , Vietnam
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Huế, , Vietnam
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Rach Gia, , Vietnam
Countries
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Central Contacts
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Other Identifiers
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D7860C00006
Identifier Type: -
Identifier Source: org_study_id
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