NCT07761117

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

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
6,950

participants targeted

Target at P75+ for phase_3

Timeline
37mo left

Started Aug 2026

Typical duration for phase_3

Geographic Reach
24 countries

364 active sites

Status
not yet recruiting

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

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

August 28, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2029

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

3 years

First QC Date

August 3, 2026

Last Update Submit

August 7, 2026

Conditions

Keywords

Heart failureElecoglipron

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

EXPERIMENTAL

Elecoglipron tablet once daily

Drug: Elecoglipron

Placebo

ACTIVE COMPARATOR

Placebo matching Elecoglipron tablet once daily

Drug: Placebo

Interventions

Elecoglipron tablet

Elecoglipron

Placebo tablet

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (366)

Research Site

Fairhope, Alabama, 36532, 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, 92350, United States

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Lomita, California, 90717, United States

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Northridge, California, 91324, United States

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Tarzana, California, 91356, United States

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New Haven, Connecticut, 06519, United States

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Hialeah, Florida, 33012, 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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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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Park Ridge, Illinois, 60068, United States

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Schaumburg, Illinois, 60173, United States

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Indianapolis, Indiana, 46254, United States

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Waterloo, Iowa, 50701, 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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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, 48076, United States

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Kansas City, Missouri, 64111, United States

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St Louis, Missouri, 63136, United States

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Millville, New Jersey, 08332, United States

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Trenton, New Jersey, 08690, 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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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, 27599, United States

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Durham, North Carolina, 27710, United States

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Greensboro, North Carolina, 27410, United States

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Statesville, North Carolina, 28625, 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, 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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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Yardley, Pennsylvania, 19067, 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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Humble, Texas, 77338, United States

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Lancaster, Texas, 75216, 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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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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Buenos Aires, C1425AGC, Argentina

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CABA, C1061, Argentina

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Córdoba, 5000, Argentina

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Córdoba, X5003DCE, 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, 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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Rockhampton, 4700, 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, 49015-380, 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, 59020-035, Brazil

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Porto Alegre, 90630-165, 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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Barrie, Ontario, L4M 6M2, 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 5W9, Canada

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Newmarket, Ontario, L3Y 2P6, Canada

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North York, Ontario, M6B 3H7, Canada

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Oakville, Ontario, L6K 3W7, 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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Toronto, Ontario, M6G 1M2, Canada

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Toronto, Ontario, M6N 1B5, Canada

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Montreal, Quebec, H4A 3J1, Canada

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Luoyang, 471001, China

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Tianjin, 300050, China

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Wuhan, 430000, China

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Zhangjiakou, 075061, 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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Jaroměř, 551 01, Czechia

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Klatovy, 339 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, 198 00, Czechia

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Teplice, 415 01, Czechia

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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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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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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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Budapest, 1122, Hungary

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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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Fukui-shi, 910-8526, Japan

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Higashiibaraki-gun, 311-3193, Japan

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Kanazawa, 920-8650, Japan

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Kasugai-shi, 486-8510, Japan

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Kyoto, 604-8845, Japan

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Kyoto, 605-0981, 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

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Nagoya, 466-8560, Japan

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Osaka, 558-8558, Japan

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Ōmihachiman, 523-0082, Japan

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Sapporo, 003-0026, Japan

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Sendai, 981-3133, Japan

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Takatsuki-shi, 569-8686, Japan

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Tokushima, 770-8503, Japan

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Toshima-ku, 171-0014, Japan

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Urasoe-Shi, 901-2102, Japan

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Uruma, 904-2293, Japan

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Wakayama, 640-8158, Japan

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Alor Star, 05460, Malaysia

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Cheras, 56000, Malaysia

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Kuala Lumpur, 50400, Malaysia

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Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Kuala Terengganu, 20400, Malaysia

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Kuantan, 25100, Malaysia

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Kuching, 93586, Malaysia

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Miri, 98000, Malaysia

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Sungai Buloh, 47000, Malaysia

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Alkmaar, 1815 JD, Netherlands

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Almere Stad, 1315 RA, Netherlands

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Amstelveen, 1186 AM, Netherlands

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Doetinchem, 7009 BL, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Rotterdam, 3015, Netherlands

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Sneek, 8601 ZR, Netherlands

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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, 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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Baia Mare, 430124, Romania

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Brasov, 500102, Romania

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Bucharest, 031441, Romania

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Bucharest, 050098, Romania

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Bucharest, 050659, Romania

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Craiova, 200505, Romania

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Satu Mare, 440055, Romania

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Timișoara, 300002, Romania

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Timișoara, 300024, Romania

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Timișoara, 300362, Romania

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Bratislava, 82107, Slovakia

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Bratislava, 83101, Slovakia

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Brezno, 977 01, Slovakia

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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

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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, 431 80, Sweden

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Örebro, 701 85, Sweden

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Stockholm, 112 81, 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

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New Taipei City, 231, Taiwan

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New Taipei City, 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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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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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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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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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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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, 70000, Vietnam

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Hochiminh City, 700000, Vietnam

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Hochiminh, 700000, Vietnam

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MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

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 (Estimated)

August 28, 2026

Primary Completion (Estimated)

September 3, 2029

Study Completion (Estimated)

September 3, 2029

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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.

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.
More information

Locations