A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF
Elevate-HF
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants With HFpEF and HFmrEF (Elevate-HF)
2 other identifiers
interventional
6,950
31 countries
665
Brief Summary
This is a Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to investigate CV outcomes with elecoglipron compared with placebo, in adults with heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), irrespective of T2DM status, and who are on background dapagliflozin in addition to other background standard of care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2026
Typical duration for phase_3
665 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2026
CompletedFirst Posted
Study publicly available on registry
August 12, 2026
CompletedStudy Start
First participant enrolled
August 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 3, 2029
September 28, 2026
August 1, 2026
3 years
August 3, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of CV death or HHF/urgent HF visit
Time to first event of the composite of: * CV death * HHF * Urgent HF visit
Up to 42 months
Secondary Outcomes (3)
To evaluate the effect of elecoglipron compared with placebo in reducing the rate of HF events (HHF or urgent HF visit)
Up to 42 months
To evaluate the effect of elecoglipron compared to placebo on improving patient-reported outcomes using a questionnaire.
Baseline and 52 weeks
To evaluate the effect of elecoglipron compared with placebo in reducing the risk of the 4-point composite of all-cause death, HHF, MI, or stroke
Up to 42 months
Study Arms (2)
Elecoglipron
EXPERIMENTALElecoglipron tablet once daily
Placebo
ACTIVE COMPARATORPlacebo matching Elecoglipron tablet once daily
Interventions
Eligibility Criteria
You may qualify if:
- Left ventricular ejection fraction (LVEF) of \> 40% within 12 months prior to screening.
- Structural heart disease evidence.
- HF diagnosed with New York Heart Association (NYHA) Class II-IV at the time of screening.
You may not qualify if:
- BMI \<25 kg/m² at screening.
- History of type 1 diabetes.
- HbA1c ≥10% at screening.
- Currently receiving or anticipated to receive therapeutic intervention for diabetic retinopathy and/or macular edema.
- more than 1 episode of severe hypoglycemic event within 180 days prior to screening, or hypoglycemia unawareness/poor recognition.
- On a prespecified renal replacement therapy, or eGFR below a prespecified threshold at screening
- Major cardiac surgery, coronary revascularization, valvular repair/replacement, AF/AFL ablation, CRT implantation, or ICD without CRT within 90 days prior to screening, or planned after randomization.
- Heart failure due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, genetic hypertrophic cardiomyopathy (including obstructive), or arrhythmogenic right ventricular cardiomyopathy/dysplasia.
- Clinically significant upper GI condition affecting gastric emptying, drug absorption, or safety/tolerability interpretation; chronic use of drugs directly affecting GI motility; severe disease or prior surgery.
- History of acute or chronic pancreatitis.
- History/ family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or basal calcitonin ≥35 ng/L at screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (679)
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Fairhope, Alabama, 36532, United States
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Anchorage, Alaska, 99508, United States
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Gilbert, Arizona, 85295, United States
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Sun City, Arizona, 85351, United States
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Beverly Hills, California, 90211, United States
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Huntington Beach, California, 92647, United States
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Huntington Park, California, 90255, United States
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Loma Linda, California, 92354, United States
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Lomita, California, 90717, United States
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Mather, California, 95655, United States
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Northridge, California, 91324, United States
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Palo Alto, California, 94304, United States
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Redding, California, 96001, United States
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San Diego, California, 92117, United States
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Tarzana, California, 91356, United States
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Colorado Springs, Colorado, 80909, United States
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New Haven, Connecticut, 06519, United States
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Bradenton, Florida, 34209, United States
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Hallandale, Florida, 33009, United States
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Jacksonville, Florida, 32209, United States
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Lakeland, Florida, 33813, United States
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Miami, Florida, 33125, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33176, United States
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Miami Lakes, Florida, 33014, United States
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Miami Lakes, Florida, 33016, United States
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Ocala, Florida, 34470, United States
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Ocoee, Florida, 34761, United States
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Palmetto Bay, Florida, 33157, United States
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Riverview, Florida, 33578, United States
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Tampa, Florida, 33617, United States
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Atlanta, Georgia, 30303, United States
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Columbus, Georgia, 31904, United States
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Tucker, Georgia, 30084, United States
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Champaign, Illinois, 61822, United States
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Chicago, Illinois, 60640, United States
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Gurnee, Illinois, 60031, United States
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Melrose Park, Illinois, 60160, United States
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Moline, Illinois, 61265, United States
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Niles, Illinois, 60714, United States
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Rockford, Illinois, 61107, United States
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Schaumburg, Illinois, 60173, United States
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Winfield, Illinois, 60190, United States
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Indianapolis, Indiana, 46254, United States
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Waterloo, Iowa, 50701, United States
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Leavenworth, Kansas, 66048, United States
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Wichita, Kansas, 67214, United States
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Owensboro, Kentucky, 42301, United States
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Bossier City, Louisiana, 71111, United States
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Covington, Louisiana, 70433, United States
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Lafayette, Louisiana, 70503, United States
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New Orleans, Louisiana, 70121, United States
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Shreveport, Louisiana, 71105, United States
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Zachary, Louisiana, 70791, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21229, United States
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Lanham, Maryland, 20706, 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, 02118, United States
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New Bedford, Massachusetts, 02740, United States
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Worcester, Massachusetts, 01655, United States
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Flint, Michigan, 48503, United States
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Southfield, Michigan, 48075, United States
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Southfield, Michigan, 48076, United States
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Troy, Michigan, 48098, United States
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Bridgeton, Missouri, 63044, United States
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Kansas City, Missouri, 64111, United States
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Kansas City, Missouri, 64112, United States
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Lincoln, Nebraska, 68510, United States
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Bridgewater, New Jersey, 08807, United States
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Millville, New Jersey, 08332, United States
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Sewell, New Jersey, 08080, United States
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Trenton, New Jersey, 08690, United States
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Vineland, New Jersey, 08360, United States
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Brooklyn, New York, 11220, United States
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Buffalo, New York, 14215, United States
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New York, New York, 10001, United States
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New York, New York, 10019, United States
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Rosedale, New York, 11422, United States
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The Bronx, New York, 10451, United States
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The Bronx, New York, 10455, United States
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Chapel Hill, North Carolina, 27514, United States
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Durham, North Carolina, 27710, United States
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Greensboro, North Carolina, 27401, United States
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Statesville, North Carolina, 28677, United States
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Wilmington, North Carolina, 28401, United States
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Fargo, North Dakota, 58104, United States
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Grand Forks, North Dakota, 58201, United States
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Columbus, Ohio, 43215, United States
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Columbus, Ohio, 43228, United States
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Dayton, Ohio, 45435, United States
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Maumee, Ohio, 43537, United States
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Oklahoma City, Oklahoma, 73134, United States
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Bethlehem, Pennsylvania, 18015, United States
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Media, Pennsylvania, 19063, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Smithfield, Pennsylvania, 15478, United States
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Yardley, Pennsylvania, 19067, United States
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East Providence, Rhode Island, 02914, United States
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Spartanburg, South Carolina, 29303, United States
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Rapid City, South Dakota, 57701, United States
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Dallas, Texas, 75216, United States
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DeSoto, Texas, 75115, United States
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El Paso, Texas, 79905, United States
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Houston, Texas, 77025, United States
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Houston, Texas, 77082, United States
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Humble, Texas, 77338, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78231, United States
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San Antonio, Texas, 78257, United States
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Tomball, Texas, 77375, United States
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Tyler, Texas, 75701, United States
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Victoria, Texas, 77901, United States
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Burlington, Vermont, 05401, United States
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Arlington, Virginia, 22205, 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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Morgantown, West Virginia, 26505, United States
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Buenos Aires, C1425AGC, Argentina
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CABA, C1061, Argentina
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Ciudad de Buenos Aires, 1060, Argentina
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Ciudad de Buenos Aires, C1428, Argentina
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Corrientes, 3400, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5003DCE, Argentina
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Córdoba, X5006CBI, Argentina
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Esperanza, S3080BQU, Argentina
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Granadero Baigorria, S2152BOF, Argentina
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Lanus, B1824KAJ, Argentina
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Mar del Plata, B7600GNY, Argentina
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Mendoza, 5500, Argentina
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Rosario, S2000CVD, Argentina
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Rosario, S2000PBJ, Argentina
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San Nicolás, B2900ACL, Argentina
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Santa Fe, S3000FWO, Argentina
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Blacktown, 2148, Australia
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Campbelltown, 2560, Australia
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Frankston, 3199, Australia
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Hoppers Crossing, 3029, Australia
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North Tamworth, 2340, Australia
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Rockhampton, 4700, Australia
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Wollongong, 2500, Australia
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Bad Ischl, 4820, Austria
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Feldkirch, 6800, Austria
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Graz, 8020, Austria
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Klagenfurt, 9020, Austria
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Linz, 4021, Austria
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Saint Stefan/Stainz, 8511, Austria
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Sankt Pölten, 3100, Austria
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Vienna, 1090, Austria
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Vienna, 1100, Austria
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Vienna, 1160, Austria
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Vienna, 1210, Austria
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Wels, 4600, Austria
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Aracaju, 49055-530, Brazil
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Belém, 66073-005, Brazil
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Bragança Paulista, 12916-542, Brazil
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Brasília, 70390-700, Brazil
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Campinas, 13060-080, Brazil
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Curitiba, 80230-130, Brazil
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Joinville, 89204-251, Brazil
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Natal, 59020-500, Brazil
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Porto Alegre, 90410-000, Brazil
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Porto Alegre, 91350-280, Brazil
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Ribeirão Preto, 14051-140, Brazil
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Rio Branco, 69915-030, Brazil
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Rio de Janeiro, 22270-060, Brazil
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São Paulo, 04012-180, Brazil
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Blagoevgrad, 2700, Bulgaria
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Dupnitsa, 2600, Bulgaria
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Haskovo, 6300, Bulgaria
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Haskovo, 6304, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4023, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1404, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1618, Bulgaria
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Sofia, 1680, Bulgaria
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Sofia, 1756, Bulgaria
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Varna, 9000, Bulgaria
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Barrie, Ontario, L4M 6M2, Canada
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Etobicoke, Ontario, M8Z 4E4, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Hamilton, Ontario, L8L 5G4, Canada
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Kingston, Ontario, K7M 7E4, Canada
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London, Ontario, N6A 5A5, Canada
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London, Ontario, N6A 5W9, Canada
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Markham, Ontario, L3P 7P3, Canada
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Markham, Ontario, L3S 0A2, Canada
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Newmarket, Ontario, L3Y 2P6, Canada
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North York, Ontario, M6B 3H7, Canada
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North York, Ontario, M9N 1W4, Canada
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Oakville, Ontario, L6K 3W7, Canada
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Ottawa, Ontario, K1Y 4W7, Canada
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Stoney Creek, Ontario, L8J 3W2, Canada
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Thunder Bay, Ontario, P7B 5N3, Canada
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Thunder Bay, Ontario, P7B 5N3, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M6G 1M2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Trois-Rivières, Quebec, G8Z 3R9, Canada
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Baoding, 072750, China
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Baotou, China
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Beijing, 100000, China
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Beijing, 100022, China
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Beijing, 100034, China
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Beijing, 100037, China
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Beijing, 100044, China
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Beijing, 100050, China
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Beijing, 100053, China
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Beijing, 100142, China
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Beijing, 102218, China
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Beijing, China
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Bozhou, 236000, China
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Changchun, 130021, China
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Changchun, 130033, China
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Changchun, 130041, China
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Changde, 415000, China
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Changsha, 410300, China
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Chengdu, 610031, China
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Chengdu, 610041, China
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Chengdu, 610078, China
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Chifeng, 024000, China
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Daqing, 163000, China
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Foshan, 528308, China
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Guangzhou, 510000, China
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Guangzhou, 510289, China
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Haikou, 570311, China
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Hefei, 230601, China
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Heze, 274099, China
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Huaian, 223300, China
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Huizhou, 516002, China
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Jiangmen, 529000, China
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Jinan, 250012, China
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Jinan, 250031, China
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Jining, 272006, China
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Lanzhou, 730000, China
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Linhai, 317000, China
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Lishui, 323000, China
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Luoyang, 471001, China
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Nanchang, 330009, China
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Nanjing, 2100008, China
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Nanjing, 210009, China
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Nanjing, 210011, China
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Nanyang, 473000, China
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Ningbo, 315000, China
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Panjin, 124009, China
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Pingxiang, 337055, China
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Qingzhou, 262550, China
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Sanya, 572000, China
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Shanghai, 200090, China
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Shanghai, 200135, China
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Shanghai, 201107, China
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Shanghai, 201199, China
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Shantou, 515041, China
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Shaoguan, 512027, China
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Shaoxing, 312000, China
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Shenyang, 110016, China
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Shenzhen, 518053, China
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Siping, 136000, China
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Suining, 629000, China
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Suzhou, 215004, China
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Suzhou, 215006, China
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Taian, 271099, China
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Tianjin, 300000, China
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Tianjin, 300050, China
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Ürümqi, 830001, China
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Wanzhou, 404000, China
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Weifang, 261000, China
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Wenzhou, 325000, China
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Wuhan, 430000, China
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Wuhan, 430033, China
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Wuxi, 214023, China
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Xi'an, 710061, China
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Xi'an, 710068, China
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Xiangtan, 411100, China
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Xuzhou, 221000, China
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Xuzhou, 221009, China
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Yancheng, 224005, China
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Yangzhou, 225001, China
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Yueyang, 414000, China
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Yuncheng, 044099, China
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Zhangjiakou, 075061, China
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Zhengzhou, 450002, China
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Zhengzhou, 450007, China
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Zhengzhou, 450052, China
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Zibo, 255036, China
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Zigong, 643021, China
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Zunyi, 563100, China
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Benešov, 256 01, Czechia
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Boskovice, 680 01, Czechia
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Brno, 60200, Czechia
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Broumov, 55001, Czechia
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Chlumec nad Cidlinou, 503 51, Czechia
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Česká Lípa, 470 77, Czechia
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Český Krumlov, 381 01, Czechia
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Hradec Králové, 500 02, Czechia
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Hustopeče, 693 01, Czechia
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Jaroměř, 551 01, Czechia
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Kadaň, 432 01, Czechia
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Klatovy, 339 01, Czechia
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Liberec, 460 01, Czechia
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Louny, 440 01, Czechia
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Prague, 130 00, Czechia
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Prague, 150 00, Czechia
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Prague, 150 00, Czechia
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Prague, 198 00, Czechia
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Teplice, 415 01, Czechia
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Vsetín, 755 01, Czechia
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Bron, 69500, France
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Corbeil-Essonnes, 91100, France
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La Tronche, 38043, France
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Le Coudray, 28630, France
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Lens, 62300, France
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Metz-Tessy, 74370, France
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Pau, 6400, France
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Rennes, 35033, France
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Rodez, 12000, France
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Rouen, 76031, France
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Saint-Brieuc, 22027, France
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Toulon, 83100, France
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Vandœuvre-lès-Nancy, 54500, France
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Bad Oldesloe, 23843, Germany
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Bamberg, 96049, Germany
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Berlin, 13187, Germany
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Berlin, 13405, Germany
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Berlin, 13509, Germany
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Bielefeld, 33604, Germany
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Bochum, 44789, Germany
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Bremen, 28277, Germany
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Chemnitz, 09116, Germany
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Cologne, 50733, Germany
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Dresden, 1307, Germany
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Elsterwerda, 04910, Germany
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Erlangen, 91504, Germany
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Essen, 45147, Germany
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Freiburg im Breisgau, 79106, Germany
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Gera, 07548, Germany
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Giessen, 35394, Germany
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Hamburg, 20099, Germany
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Hamburg, 21075, Germany
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Hamburg, 22459, Germany
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Hamburg, 22559, Germany
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Heidelberg, 69120, Germany
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Homburg, 66424, Germany
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Jena, 07747, Germany
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Kaiserslautern, 67655, Germany
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Karlsbad, 76307, Germany
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Kiel, 24105, Germany
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Ludwigshafen, 67063, Germany
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Ludwigshafen am Rhein, 67071, Germany
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Lüneburg, 21339, Germany
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Magdeburg, 39120, Germany
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Mainz, 55122, Germany
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Mainz, 55131, Germany
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Markkleeberg, 04416, Germany
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Mühldorf A. Inn, 84453, Germany
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Neuruppin, 16816, Germany
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Nuremberg, 90402, Germany
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Obertshausen, 63179, Germany
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Paderborn, 33098, Germany
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Papenburg, 26871, Germany
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Stuttgart, 70199, Germany
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Trier, 54292, Germany
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Tübingen, 72076, Germany
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Ulm, 89077, Germany
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Weyhe, 28844, Germany
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Athens, 11521, Greece
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Athens, 11526, Greece
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Athens, 11527, Greece
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Athens, 11528, Greece
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Athens, 15123, Greece
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Dragana, 68100, Greece
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Heraklion, 71409, Greece
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Heraklio, 71110, Greece
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Thessaloniki, 54636, Greece
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Voula, 16673, Greece
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Balatonfüred, 8230, Hungary
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Budapest, 1122, Hungary
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Budapest, 1132, Hungary
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Budapest, 1134, Hungary
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Dunaújváros, 2400, Hungary
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Kaposvár, 7400, Hungary
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Miskolc, 3530, Hungary
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Nyíregyháza, 4400, Hungary
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Orosháza, 5900, Hungary
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Szeged, 6725, Hungary
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Szombathely, 9700, Hungary
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Zalaegerszeg, 8900, Hungary
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Belagavi, 590010, India
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Calicut, 673008, India
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Coimbatore, 641018, India
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Dehradun, 248001, India
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Delhi, 110029, India
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Delhi, 110062, India
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Hyderabad, 500035, India
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Jaipur, 302017, India
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Kanpur, 208001, India
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Kochi, 682018, India
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Kochi, 682040, India
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Kolkata, 700014, India
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Kolkata, 700020, India
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Ludhiana, 141001, India
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Meerut, 250005, India
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Mumbai, 400012, India
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Nagpur, 441108, India
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New Delhi, 110017, India
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Rudrapur, 263153, India
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Vadodara, 390002, India
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Ancona, 60100, Italy
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Bergamo, 24127, Italy
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Brescia, 25123, Italy
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Milan, 20132, Italy
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Pavia, 27100, Italy
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Perugia, 06132, Italy
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Riccione, 47838, Italy
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Salerno, 84131, Italy
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Sesto San Giovanni, 20099, Italy
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Vizzolo Predabissi, 20070, Italy
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Aomori, 030-8553, Japan
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Chikushino-shi, 818-8516, Japan
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Chūōku, 103-0027, Japan
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Fukui-shi, 910-8526, Japan
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Fukushima, 960-1295, Japan
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Higashiibaraki-gun, 311-3193, Japan
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Higashiohmi-shi, 527-8505, Japan
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Iwakuni-shi, 740-8510, Japan
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Kagoshima, 890-8760, Japan
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Kamakura-shi, 247-8533, Japan
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Kanazawa, 920-8650, Japan
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Kashihara-shi, 634-8522, Japan
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Kasugai-shi, 486-8510, Japan
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Kawagoe-shi, 350-8550, Japan
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Kishiwada-shi, 596-0042, Japan
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Kitakyusyu-shi, 806-8501, Japan
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Kobe, 650-0017, Japan
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Kobe, 650-0047, Japan
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Kobe, 654-0081, Japan
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Kobe, 654-0155, Japan
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Kure-shi, 737-0193, Japan
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Kyoto, 604-8845, Japan
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Kyoto, 605-0981, Japan
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Maebashi, 371-8511, Japan
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Matsusaka-shi, 515-8557, Japan
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Minatoku, 108-0073, Japan
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Mito, 311-4198, Japan
Research Site
Morioka, 020-0066, Japan
Research Site
Nagasaki, 851-0301, Japan
Research Site
Nagoya, 454-8502, Japan
Research Site
Nagoya, 466-8560, Japan
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Nagoya, 467-8602, Japan
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Osaka, 558-8558, Japan
Research Site
Ōmihachiman, 523-0082, Japan
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Sagamihara-shi, 252-0315, Japan
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Sapporo, 003-0026, Japan
Research Site
Sayama-shi,, 350-1305, Japan
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Sendai, 981-3133, Japan
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Shibuya-ku, 150-0013, Japan
Research Site
Shizuoka, 420-8527, Japan
Research Site
Shizuoka, 420-8630, Japan
Research Site
Suginami City, 168-0065, Japan
Research Site
Suita, 565-0862, Japan
Research Site
Suzuka-shi, 513-8630, Japan
Research Site
Tachikawa-shi, 190-8531, Japan
Research Site
Takaoka-shi, 933-8555, Japan
Research Site
Takatsuki-shi, 569-8686, Japan
Research Site
Tokushima, 770-8503, Japan
Research Site
Toshima-ku, 171-0014, Japan
Research Site
Toyama, 930-8550, Japan
Research Site
Ueda-shi, 386-8610, Japan
Research Site
Urasoe-Shi, 901-2102, Japan
Research Site
Urayasu-shi, 279-0021, Japan
Research Site
Uruma, 904-2293, Japan
Research Site
Utsunomiya, 320-8580, Japan
Research Site
Wakayama, 640-8158, Japan
Research Site
Yakushi, 581-0011, Japan
Research Site
Yokohama, 224-8503, Japan
Research Site
Yokohama, 231-8682, Japan
Research Site
Yokohama, 236-0004, Japan
Research Site
Yokohama, 236-0037, Japan
Research Site
Alor Star, 05460, Malaysia
Research Site
Cheras, 56000, Malaysia
Research Site
Kajang, 43000, Malaysia
Research Site
Kuala Lumpur, 50400, Malaysia
Research Site
Kuala Lumpur, 50586, Malaysia
Research Site
Kuala Lumpur, 59100, Malaysia
Research Site
Kuala Terengganu, 20400, Malaysia
Research Site
Kuantan, 25100, Malaysia
Research Site
Kuching, 93586, Malaysia
Research Site
Miri, 98000, Malaysia
Research Site
Sungai Buloh, 47000, Malaysia
Research Site
Guadalajara, 44676, Mexico
Research Site
México, 06090, Mexico
Research Site
México, 14080, Mexico
Research Site
Monterrey, 64030, Mexico
Research Site
Monterrey, 64060, Mexico
Research Site
Monterrey, 64460, Mexico
Research Site
Querétaro, 76000, Mexico
Research Site
San Luis Potosí City, 78200, Mexico
Research Site
Tijuana, 22150, Mexico
Research Site
Xalapa, 91193, Mexico
Research Site
Zapopan, 45070, Mexico
Research Site
Alkmaar, 1815 JD, Netherlands
Research Site
Almere Stad, 1315 RA, Netherlands
Research Site
Amstelveen, 1186 AM, Netherlands
Research Site
Doetinchem, 7009 BL, Netherlands
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Leeuwarden, 8934 AD, Netherlands
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Rotterdam, 3015, Netherlands
Research Site
Sneek, 8601 ZR, Netherlands
Research Site
The Hague, 2545 AA, Netherlands
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Tilburg, 5042 AD, Netherlands
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Zutphens, 7207 AE, Netherlands
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Zwolle, 8025 AB, Netherlands
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Bialystok, 15-375, Poland
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Bialystok, 15-481, Poland
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Częstochowa, 42-217, Poland
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Gdynia, 81-157, Poland
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Gdynia, 81-338, Poland
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Katowice, 40-600, Poland
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Katowice, 40-635, Poland
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Krakow, 30-082, Poland
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Krakow, 30-901, Poland
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Krakow, 31-271, Poland
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Poznan, 61-848, Poland
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Przemyśl, 37-700, Poland
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Radzionków, 41-922, Poland
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Skórzewo, 60-185, Poland
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Szczecin, 71-526, Poland
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Torun, 87-100, Poland
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Warsaw, 02-758, Poland
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Warsaw, 04-628, Poland
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Wroclaw, 50-981, Poland
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Włocławek, 87-800, Poland
Research Site
Baia Mare, 430124, Romania
Research Site
Brasov, 500102, Romania
Research Site
Bucharest, 031441, Romania
Research Site
Bucharest, 050098, Romania
Research Site
Bucharest, 050659, Romania
Research Site
Craiova, 200505, Romania
Research Site
Satu Mare, 440055, Romania
Research Site
Timișoara, 300002, Romania
Research Site
Timișoara, 300024, Romania
Research Site
Timișoara, 300362, Romania
Research Site
Bratislava, 82107, Slovakia
Research Site
Bratislava, 83101, Slovakia
Research Site
Bratislava, 83101, Slovakia
Research Site
Brezno, 977 01, Slovakia
Research Site
Košice, 04001, Slovakia
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Košice, 04022, Slovakia
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Lučenec, 984 01, Slovakia
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Lučenec, 98401, Slovakia
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Nitra, 949 11, Slovakia
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Prešov, 08001, Slovakia
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Svidník, 08901, Slovakia
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Šahy, 93601, Slovakia
Research Site
Busan, 49201, South Korea
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Busan, 49267, South Korea
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Daegu, 42601, South Korea
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Daejeon, 35015, South Korea
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Gwangju, 61469, South Korea
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Gyeonggi-do, 13620, South Korea
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Incheon, 21431, South Korea
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Incheon, 22332, South Korea
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Seongbuk-Gu, 02841, South Korea
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Seoul, 04763, South Korea
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Seoul, 05278, South Korea
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Seoul, 06591, South Korea
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Seoul, 3722, South Korea
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Seoul, 5505, South Korea
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Suwon, 16499, South Korea
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Uijeongbu-si, 11765, South Korea
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Yangsan, 50612, South Korea
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Barcelona, 08003, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Jaén, 23007, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Murcia, 30120, Spain
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Salamanca, 37007, Spain
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Sanlúcar de Barrameda (Cádiz), 11540, Spain
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Seville, 41013, Spain
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Valencia, 46010, Spain
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Valencia, 46014, Spain
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Valencia, 46026, Spain
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Villamartín, 11650, Spain
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Gothenburg, 416 85, Sweden
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Jönköping, 553 05, Sweden
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Karlstad, 651 85, Sweden
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Lund, 222 21, Sweden
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Mölndal, SE431 80, Sweden
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Örebro, 701 85, Sweden
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Stockholm, 112 19, Sweden
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Stockholm, 113 61, Sweden
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Stockholm, 118 83, Sweden
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Stockholm, 171 64, Sweden
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Uppsala, 751 85, Sweden
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Kaohsiung City, 80756, Taiwan
Research Site
New Taipei City, 220, Taiwan
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New Taipei City, 231, 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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Taipei, 10002, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 110, Taiwan
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Taipei, 11101, Taiwan
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Taipei, 11217, Taiwan
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Taipei, 11490, Taiwan
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Taoyuan, 333, Taiwan
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Yilan, 260, Taiwan
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Bangkok, 10300, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Changwat Sara Buri, 18000, Thailand
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Chiang Mai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Khlong Luang, 12120, Thailand
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Khon Kaen, 40002, Thailand
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Phitsanulok, 65000, Thailand
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Ratchaburi, 70000, Thailand
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Adana, 01330, Turkey (Türkiye)
Research Site
Ankara, 06530, Turkey (Türkiye)
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Antalya, 07100, Turkey (Türkiye)
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Center, 23200, Turkey (Türkiye)
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Center, 78200, Turkey (Türkiye)
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Istanbul, 34300, Turkey (Türkiye)
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Izmir, 35330, Turkey (Türkiye)
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Kahramanmaraş, 46100, Turkey (Türkiye)
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Kütahya, 43100, Turkey (Türkiye)
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Odunpazari, 26040, Turkey (Türkiye)
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Odunpazari, 26080, Turkey (Türkiye)
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Yenimahalle, 06170, Turkey (Türkiye)
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Kyiv, 01601, Ukraine
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Kyiv, 02002, Ukraine
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Kyiv, 03037, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 03057, Ukraine
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Kyiv, 03151, Ukraine
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Kyiv, 04050, Ukraine
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Kyiv, 04114, Ukraine
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Kyiv, 04210, 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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Abo Dhabi, 20011, United Arab Emirates
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Abu Dhabi, 11001, United Arab Emirates
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Abu Dhabi, 48481, United Arab Emirates
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Ashton-under-Lyne, OL6 6EW, United Kingdom
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Basildon, SS16 5NL, United Kingdom
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Belfast, BT16 1RH, United Kingdom
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Birmingham, B75 7RR, United Kingdom
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Brighton, BN2 5BE, United Kingdom
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Bristol, BS34 5TF, United Kingdom
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Cardiff, CF14 4XW, United Kingdom
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Clydebank, G81 4DY, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Glasgow, G51 4TF, United Kingdom
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Kings Lynn, PE30 4ET, United Kingdom
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Leeds, LS1 3EX, United Kingdom
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London, EC1M 6BQ, United Kingdom
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Sandbach, CW11 1EQ, United Kingdom
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Southampton, SO303JB, United Kingdom
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Woodbridge, IP136TH, United Kingdom
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Can Tho, 900000, Vietnam
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Hanoi, 100000, Vietnam
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Hà Nội, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Hochiminh City, 700000, Vietnam
Research Site
Hochiminh, 700000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Placebo controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2026
First Posted
August 12, 2026
Study Start
August 24, 2026
Primary Completion (Estimated)
September 3, 2029
Study Completion (Estimated)
September 3, 2029
Last Updated
September 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.