Diabetic Kidney DiseasePhase 3FIGARO-DKDNCT02545049
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
A Phase 3 study testing Finerenone (BAY94-8862) in people with Diabetic Kidney Disease, run by Bayer at 975 sites in 48 countries.
Trial summary
The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Finerenone (BAY94-8862)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,352 participants
- Where
- 975 sitesin 48 countries
- Study dates
- 17 Sep 2015to 2 Feb 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ≥18 years of age
- Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes Association
- Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
- Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
- Serum potassium <=4.8 mmol/L
Who cannot join
- Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis
- Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)
- Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit [class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)]
- Dialysis for acute renal failure within 12 weeks of Run-in visit
- Renal allograft in place or scheduled kidney transplant within next 12 months
- Glycated hemoglobin (HbA1c) >12%
Trial locations and contacts
975 sites in 48 countries.
975 sites in 48 countries
United States173 sites
Study site
Albany, New York, 12203
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Albuquerque, New Mexico, 87106
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Alexandria, Virginia, 22304
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Anderson, South Carolina, 29625
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Ann Arbor, Michigan, 48109
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Arlington, Texas, 76014
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Asheboro, North Carolina, 27203
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Atlanta, Georgia, 30303
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Atlanta, Georgia, 30342
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Augusta, Georgia, 30904
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Bakersfield, California, 93309
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Beaver, Pennsylvania, 15009
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Bethlehem, Pennsylvania, 18017
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Birmingham, Alabama, 35294-2041
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Boston, Massachusetts, 02215
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Brooklyn, New York, 11203
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Brooklyn, New York, 11229
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Burlington, Vermont, 05401
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Canton, Ohio, 44718
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Chapel Hill, North Carolina, 27312
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28207
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Charlottesville, Virginia, 22908
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Chattanooga, Tennessee, 37404
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Chicago, Illinois, 60612
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Chula Vista, California, 91910
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Columbia, Missouri, 65201
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Columbia, Missouri, 65212
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Corpus Christi, Texas, 78414
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Dallas, Texas, 75216
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Dallas, Texas, 75246
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Dallas, Texas, 75251
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Dublin, California, 94568
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El Centro, California, 92243
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El Paso, Texas, 79902-4672
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Elgin, Illinois, 60123
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Flint, Michigan, 48504
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Flint, Michigan, 48532
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Fort Lauderdale, Florida, 33308
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Fort Lauderdale, Florida, 33312
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Fort Lauderdale, Florida, 33316-1958
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Fort Payne, Alabama, 35967
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Fresno, California, 93720
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Fresno, California, 93721
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Greenville, North Carolina, 27834
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Greenville, South Carolina, 29607
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Hershey, Pennsylvania, 17033
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Hialeah, Florida, 33012
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Hialeah, Florida, 33016
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Hollywood, Florida, 33024
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Honolulu, Hawaii, 96814
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Houston, Texas, 77008
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Houston, Texas, 77018
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Houston, Texas, 77024
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Houston, Texas, 77040
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Houston, Texas, 77061
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Houston, Texas, 77079
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Houston, Texas, 77095
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Huntsville, Alabama, 35801-4317
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Hutchinson, Kansas, 67502-1131
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Indianapolis, Indiana, 46202
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32204
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Jefferson City, Missouri, 65109
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Jersey Shore, Pennsylvania, 17740
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Kalamazoo, Michigan, 49009
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Kansas City, Missouri, 64111
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Kansas City, Missouri, 64128
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Kingwood, Texas, 77339
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La Mesa, California, 91942
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Las Vegas, Nevada, 89086
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Las Vegas, Nevada, 89102
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Las Vegas, Nevada, 89113-2215
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Las Vegas, Nevada, 89119
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Las Vegas, Nevada, 89128
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Lawrenceville, Georgia, 30046
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Loma Linda, California, 92357
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Los Angeles, California, 90017
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Los Angeles, California, 90022
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Los Angeles, California, 90025
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Los Angeles, California, 90073
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Macon, Georgia, 31210
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Manassas, Virginia, 20110
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McAllen, Texas, 78503
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McKinney, Texas, 75069
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Memphis, Tennessee, 38104
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Memphis, Tennessee, 38120
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Memphis, Tennessee, 38163
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Mesa, Arizona, 85210
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Metairie, Louisiana, 70006
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Miami, Florida, 33032
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Miami, Florida, 33126
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Miami, Florida, 33130
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Miami, Florida, 33144
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Miami, Florida, 33145
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Miami, Florida, 33155
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Miami, Florida, 33156
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Miami, Florida, 33165
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Miami, Florida, 33173
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Miami, Florida, 33175
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Miami, Florida, 33186
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Miami Beach, Florida, 33140
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Miami Gardens, Florida, 33014
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Miami Lakes, Florida, 33014
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Miami Lakes, Florida, 33016
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Minneapolis, Minnesota, 55455
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Missouri City, Texas, 77459
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Monroe, Louisiana, 71201
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Morton, Illinois, 61550
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Murrells Inlet, South Carolina, 29576
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Myrtle Beach, South Carolina, 29588
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Nashville, Tennessee, 37205
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Nashville, Tennessee, 37208
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Nashville, Tennessee, 37232-1371
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New Bern, North Carolina, 28562
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New Haven, Connecticut, 06520
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New Orleans, Louisiana, 70112
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New Port Richey, Florida, 34652
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New York, New York, 10029
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Newark, New Jersey, 07103
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Northridge, California, 91325
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Ocala, Florida, 34471
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Omaha, Nebraska, 68124
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Omaha, Nebraska, 68131
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Orangeburg, South Carolina, 29118
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Orlando, Florida, 32825
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Palm Harbor, Florida, 34684
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Pearland, Texas, 77584
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Pflugerville, Texas, 78660
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Phoenix, Arizona, 85016
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Phoenix, Arizona, 85032
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Port Hueneme, California, 93041
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Poway, California, 92064
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Prescott, Arizona, 86301
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Rancho Cucamonga, California, 91730
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Reno, Nevada, 89511
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Rialto, California, 92377
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Rosedale, New York, 11422
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Roseville, California, 95661
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Salem, Virginia, 24153
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Salt Lake City, Utah, 84108
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San Antonio, Texas, 78212
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San Antonio, Texas, 78215
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San Antonio, Texas, 78229-3900
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San Diego, California, 92117
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Santa Rosa, California, 95405
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Sarasota, Florida, 34239
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Shreveport, Louisiana, 71101
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Smithtown, New York, 11787
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Spokane, Washington, 99204
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Springfield, Illinois, 62702-1311
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St Louis, Missouri, 63106
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St Louis, Missouri, 63136
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Staten Island, New York, 10301
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Sugar Land, Texas, 77478
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Sugar Land, Texas, 77479
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Tacoma, Washington, 98405
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Tampa, Florida, 33614
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Tomball, Texas, 77375
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Topeka, Kansas, 66606
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Torrance, California, 90502
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Tucson, Arizona, 85723
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Tucson, Arizona, 85724
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Virginia Beach, Virginia, 23462
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Vista, California, 92083
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Waco, Texas, 76708
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Waterbury, Connecticut, 06708
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West Des Moines, Iowa, 50265
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West Palm Beach, Florida, 33401-3430
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Wichita, Kansas, 67214
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Willoughby Hills, Ohio, 44094
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Winston-Salem, North Carolina, 27157
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Winter Haven, Florida, 33880
Japan71 sites
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Asahikawa, Hokkaido, 078-8234
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Atsugi, Kanagawa, 243-0035
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Beppu, Oita Prefecture, 874-0011
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Chikushino-shi, Fukuoka, 818-8502
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Fujisawa, Kanagawa, 251-0041
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Fukui, 910-8526
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Fukui, 918-8503
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Fukuoka, 811-0213
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Fukuoka, 814-0180
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Fukuoka, 815-8555
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Funabashi, Chiba, 273-8588
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Hakodate, Hokkaido, 041-8680
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Higashihiroshima, Hiroshima, 739-0041
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Ichikawa, Chiba, 272-8516
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Iwata, Shizuoka, 438-8550
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Kagoshima, 890-8760
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Kamakura, Kanagawa, 247-8533
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Kasuga, Fukuoka, 816-0864
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Kawaguchi, Saitama, 332-0012
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Kitakyushu, Fukuoka, 800-0296
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Kitakyushu, Fukuoka, 802-8555
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Kitakyushu, Fukuoka, 805-8508
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Kitakyushu, Fukuoka, 807-0857
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Kobe, Hyōgo, 650-0047
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Komatsu, Ishikawa-ken, 923-8560
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Kumamoto, 861-4193
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Kumamoto, 861-8520
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Kumamoto, 862-0976
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Maebashi, Gunma, 371-0821
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Matsubara, Osaka, 580-0032
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Matsuyama, Ehime, 790-0024
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Matsuyama, Ehime, 791-8026
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Minato, Tokyo, 108-0073
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Musashino, Tokyo, 180-8610
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Nagasaki, 852-8511
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Nagoya, Aichi-ken, 451-8511
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Nagoya, Aichi-ken, 456-0058
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Nagoya, Aichi-ken, 457-8510
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Nagoya, Aichi-ken, 460-0001
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Nagoya, Aichi-ken, 466-8650
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Naka, Ibaraki, 311-0113
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Nakagami-gun, Okinawa, 901-2393
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Obihiro, Hokkaido, 080-0848
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Ōgaki, Gifu, 503-8502
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Osaka, 530-0001
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Osaka, 530-8480
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Osaka, 543-0035
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Osaka, 553-0003
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Osaka, 558-8558
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Ōtsu, Shiga, 520-0804
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Oyama, Tochigi, 323-0022
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Saitama, 331-8577
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Sanuki, Kagawa-ken, 769-2393
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Sapporo, Hokkaido, 007-0841
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Sasebo, Nagasaki, 857-1195
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Sayama, Saitama, 350-1305
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Shibuya-ku, Tokyo, 150-0002
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Shimajiri, Okinawa, 901-0493
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Shirakawa, Fukushima, 961-0005
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Suita, Osaka, 565-0862
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Tacchikawa, Tokyo, 190-8531
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Takamatsu, Kagawa-ken, 760-0017
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Takamatsu, Kagawa-ken, 760-0018
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Tamana, Kumamoto, 865-0016
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Toyota, Aichi-ken, 471-8513
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Ushiku, Ibaraki, 300-1207
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Yatsushiro, Kumamoto, 866-0824
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Yokohama, Kanagawa, 235-0045
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Yokohama, Kanagawa, 245-8575
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Yokohama, Kanagawa, 247-8581
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Yufu, Oita Prefecture, 879-5593
China60 sites
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Beijing, 100028
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Beijing, 100050
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Beijing, 100071
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Beijing, 100730
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Changchun, Jilin, 130000
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Changchun, Jilin, 130021
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Changsha, Hunan, 410008
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Changsha, Hunan, 410011
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Changsha, Hunan, 410013
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Changzhou, Jiangsu, 213004
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Chengdu, Sichuan, 610041
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Chengdu, Sichuan, 610072
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Chongqing, 400010
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Guangzhou, Guangdong, 510080
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Guangzhou, Guangdong, 510120
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Guangzhou, Guangdong, 510150
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Guangzhou, Guangdong, 510405
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Guangzhou, Guangdong, 510630
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Haikou, Hainan, 570102
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Haikou, Hainan, 570311
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Hangzhou, Zhejiang, 310013
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Hohhot, Inner Mongolia, 010017
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Huai'an, Jiangsu, 223300
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Lanzhou, Gansu, 730030
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Lianyungang, Jiangsu, 222002
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Nanchang, Jiangxi, 330006
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Nanchang, Jiangxi, 330008
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Nanjing, Jiangsu, 210002
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Nanjing, Jiangsu, 210006
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Nanjing, Jiangsu, 210008
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Nanjing, Jiangsu, 210011
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Nanjing, Jiangsu, 210029
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Nanning, Guangxi, 530021
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Nanning, Guangxi, 530031
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Qingdao, Shandong, 266071
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Shanghai, 200025
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Shanghai, 200040
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Shanghai, 200062
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Shanghai, 200072
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Shanghai, 200092
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Shanghai, 200240
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Shanghai, 201199
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Shenyang, Liaoning, 110016
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Shenyang, Liaoning, 110022
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Suzhou, Jiangsu, 215006
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Taiyuan, Shanxi, 030001
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Taizhou, Zhejiang, 317000
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Tianjin, 300121
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Tianjin, 300142
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Ürümqi, Xinjiang, 830054
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Wenzhou, Zhejiang, 325000
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Wuhan, Hubei, 430022
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Wuhan, Hubei, 430034
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Wuxi, Jiangsu, 214023
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Xi'an, Shaanxi, 710061
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Xiamen, Fujian, 361003
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Xiamen, Fujian, 361004
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Yancheng, Jiangsu, 224000
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Yinchuan, Ningxia, 750004
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Zhuhai, Guangdong, 519000
Russia53 sites
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Arkhangelsk, 163001
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Barnaul, 656024
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Chelyabinsk, 454021
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Irkutsk, 664079
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Izhevsk, 426063
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Kazan', 420012
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Kazan', 420101
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Kemerovo, 650002
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Kemerovo, 650055
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Kemerovo, 650066
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Kirov, 610014
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Krasnodar, 350086
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Krasnoyarsk, 660062
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Kursk, 305004
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Moscow, 111539
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Moscow, 117292
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Moscow, 119034
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Moscow, 119192
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Moscow, 119991
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Moscow, 123182
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Moscow, 123423
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Moscow, 125101
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Moscow, 125315
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Moscow, 129110
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Nizhny Novgorod, 603018
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Nizhny Novgorod, 603126
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Novosibirsk, 630005
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Novosibirsk, 630047
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Novosibirsk, 630068
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Novosibirsk, 630089
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Novosibirsk, 630117
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Omsk, 644024
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Omsk, 644033
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Omsk, 644112
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Orenburg, 460040
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Perm, 614097
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Saint Petersburg, 193312
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Saint Petersburg, 194044
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Saint Petersburg, 194223
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Saint Petersburg, 194354
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Saint Petersburg, 195067
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Saint Petersburg, 195112
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Saint Petersburg, 195257
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Saint Petersburg, 197762
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Saint Petersburg, 199226
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Saratov, 410030
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Stavropol, 355030
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Syktyvkar, 167981
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Voronezh, 394018
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Voronezh, 394077
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Yaroslavl, 150003
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Yaroslavl, 150062
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Yekaterinburg, 620102
Germany35 sites
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Bad Homburg, Hesse, 61348
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Bad König, Hesse, 64732
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Bad Oeynhausen, North Rhine-Westphalia, 32545
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Berlin, 10437
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Berlin, 12203
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Berlin, 13187
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Berlin, 13347
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Dortmund, North Rhine-Westphalia, 44137
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Dresden, Saxony, 01277
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Dresden, Saxony, 01307
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Düsseldorf, North Rhine-Westphalia, 40210
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Düsseldorf, North Rhine-Westphalia, 40225
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Elsterwerda, Brandenburg, 04910
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Essen, North Rhine-Westphalia, 45136
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Frankfurt am Main, Hesse, 60313
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Frankfurt am Main, Hesse, 60596
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Göttingen, Lower Saxony, 37075
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Hamburg, 22041
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Hanover, Lower Saxony, 30625
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Heidelberg, Baden-Wurttemberg, 69115
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Jena, Thuringia, 07747
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Leipzig, Saxony, 04103
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Leipzig, Saxony, 04249
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Leipzig, Saxony, 04315
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Ludwigsburg, Baden-Wurttemberg, 71640
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Ludwigshafen am Rhein, Rhineland-Palatinate, 67059
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Magdeburg, Saxony-Anhalt, 39120
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Mainz, Rhineland-Palatinate, 55128
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Münster, North Rhine-Westphalia, 48145
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Nettetal, North Rhine-Westphalia, 41334
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Nuremberg, Bavaria, 90443
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Schweinfurt, Bavaria, 97421
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Sinzheim, Baden-Wurttemberg, 76547
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Witten, North Rhine-Westphalia, 58455
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Würzburg, Bavaria, 97080
Canada31 sites
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Burnaby, British Columbia, V3J 1N4
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Cambridge, Ontario, N1R 7L6
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Coquitlam, British Columbia, V3K 3P4
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Edmonton, Alberta, T5A 4L8
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Greater Sudbury, Ontario, P3A 1W8
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Greenfield Park, Quebec, J4V 2H1
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Halifax, Nova Scotia, B3H 1V8
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Hamilton, Ontario, L8M 1K7
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Hamilton, Ontario, L8N 4A6
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Kitchener, Ontario, N2G 4V5
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Laval, Quebec, H7T 2P5
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Mirabel, Quebec, J7J 2K8
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Montreal, Quebec, H1M 1B1
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Montreal, Quebec, H2K 1H2
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Montreal, Quebec, H4A 3J1
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Montreal, Quebec, H4A 3T2
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Montreal, Quebec, H4J 1C5
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Mount Pearl, Newfoundland and Labrador, A1N 1W7
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New Westminster, British Columbia, V3L 0A6
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Newmarket, Ontario, L3Y 5G8
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Oshawa, Ontario, L1G 2B9
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Ottawa, Ontario, K1K 4L2
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Québec, G1V 4W2
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Sarnia, Ontario, N7T 4X3
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Smith Falls, Ontario, K7A 4W8
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St. John's, Newfoundland and Labrador, A1A 3R5
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Thornhill, Ontario, L4J 1W3
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Toronto, Ontario, M3J 1N2
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Toronto, Ontario, M4G 3E8
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Toronto, Ontario, M5C 2T2
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Waterloo, Ontario, N2J 1C4
Spain26 sites
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A Coruña, 15006
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Alcalá de Henares, Madrid, 28805
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Badalona, Barcelona, 08916
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Barcelona, 08003
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Barcelona, 08023
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Barcelona, 08025
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Barcelona, 08035
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Barcelona, 08036
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Burela de Cabo, Lugo, 27880
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Córdoba, 14004
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Ferrol, A Coruña, 15405
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Getafe, Madrid, 28905
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Granada, 18012
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Jaén, 23007
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Jerez de la Frontera, Cádiz, 11407
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L'Hospitalet de Llobregat, Barcelona, 08907
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Madrid, 28007
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Madrid, 28041
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Málaga, 29010
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Manresa, Barcelona, 08243
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Sagunto, Valencia, 46520
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Sant Joan Despí, Barcelona, 08970
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Valencia, 46010
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Valencia, 46014
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Valencia, 46017
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Valencia, 46026
Brazil24 sites
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Aparecida de Goiânia, Goiás, 74935-530
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Brasília, Federal District, 70.200-730
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Campina Grande do Sul, Paraná, 83430 000
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Curitiba, Paraná, 80030-110
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Curitiba, Paraná, 80230-130
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Curitiba, Paraná, 80440-020
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Fortaleza, Ceará, 60115-282
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Fortaleza, Ceará, 60430-140
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Fortaleza, Ceará
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Goiânia, Goiás, 74605-020
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Juiz de Fora, Minas Gerais, 36036-330
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Porto Alegre, Rio Grande do Sul, 90430-001
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Porto Alegre, Rio Grande do Sul, 90610-000
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Rio de Janeiro, 20241-180
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Rio de Janeiro, 21941-913
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São Bernardo do Campo, São Paulo, 09715-090
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São José do Rio Preto, São Paulo, 15090-000
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São José dos Campos, São Paulo, 12243-280
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São Paulo, São Paulo, 04029-000
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São Paulo, São Paulo
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São Paulo, 01223-001
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São Paulo, 01228-200
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São Paulo, 04039-000
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Uberlândia, Minas Gerais, 38411-186
Poland24 sites
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Bialystok, 15-351
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Bydgoszcz, 85-079
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Chojnice, 89-600
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Gdansk, 80-952
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Gdynia, 81-537
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Katowice, 40-040
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Krakow, 30-510
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Krakow, 31-156
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Krakow, 31-261
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Krakow, 31-559
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Lodz, 90-153
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Lodz, 92-213
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Lodz, 94-060
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Lublin, 20-538
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Poznan, 60-834
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Rzeszów, 35-055
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Skorzewo, 60-185
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Szczecin, 70-111
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Torun, 87-100
Study site
Warsaw, 01-868
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Warsaw
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Wroclaw, 51-162
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Wroclaw, 51-685
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Zabrze, 41-800
Czechia23 sites
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Beroun, 266 01
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Brandýs nad Labem, 250 01
Study site
Břeclav, 690 02
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Česká Lípa, 470 01
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Český Krumlov, 381 01
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Český Krumlov, 381 27
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Frýdek-Místek, 738 01
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Hodonín, 695 01
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Holešov, 769 01
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Hranice, 753 001
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Kopřivnice, 742 21
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Krnov, 794 01
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Mladá Boleslav, 293 50
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Olomouc, 775 20
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Olomouc, 779 00
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Ostrava, 702 00
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Pilsen, 301 66
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Prague, 12808
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Prague, 140 00
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Prague, 140 46
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Prague, 150 00
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Prague, 169 00
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Vlašim, 258 01
Italy22 sites
Study site
Bergamo, Lombardy, 24020
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Bergamo, Lombardy, 24047
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Bergamo, Lombardy, 24127
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Bologna, Emilia-Romagna, 40138
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Cagliari, Sardinia, 09134
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Catania, Sicily, 95124
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Genoa, Liguria, 16011
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Genoa, Liguria, 16132
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Messina, Sicily, 98125
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Milan, Lombardy, 20024
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Milan, Lombardy, 20132
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Milan, Lombardy, 20142
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Milan, Lombardy, 20157
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Monza Brianza, Lombardy, 20832
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Naples, Campania, 80131
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Parma, Emilia-Romagna, 43126
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Pisa, Tuscany, 56124
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Reggio Emilia, Emilia-Romagna, 42123
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Sassari, Sardinia, 07026
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Turin, Piedmont, 10024
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Turin, Piedmont, 10043
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Verona, Veneto, 37126
Ukraine21 sites
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Cherkasy, 18009
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Chernivtsi, 58002
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Dnipro, 49000
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Dnipro, 49023
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Ivano-Frankivsk, 76008
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Kharkiv, 61037
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Kharkiv, 61039
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Kharkiv, 61058
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Kharkiv, 61070
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Kiev, 01021
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Kiev, 04050
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Kiev, 04114
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Kiev, 1601
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Kyiv, 03037
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Kyiv, 03049
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Lviv, 79010
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Mykolayiv, 54003
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Ternopil, 46002
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Vinnytsia, 21001
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Zaporizhzhya, 69000
Study site
Zaporizhzhya, 69001
Hungary20 sites
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Baja, 6500
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Balatonfüred, 8230
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Budapest, 1036
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Budapest, 1042
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Budapest, 1083
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Budapest, 1088
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Budapest, 1089
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Budapest, 1134
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Budapest, 1135
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Debrecen, 4031
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Eger, 3300
Study site
Kistarcsa, H-2143
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Nyíregyháza, 4400
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Nyíregyháza, 4405
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Pápa, 8500
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Siófok, 8600
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Szeged, 6725
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Székesfehérvár, 8000
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Szentes, 6600
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Szombathely, 9700
Israel20 sites
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Afula, 1834111
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Ashkelon, 7830604
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Beersheba, 8410101
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Haifa, 3109601
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Holon, 5822012
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Jerusalem, 9112001
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Kfar Saba, 4428164
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Nahariya, 2210001
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Nahariya, 22100
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Nazareth, 16100
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Ramat Gan, 5262000
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Rehovot, 7610001
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Safed, 1311001
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Sakhnin, 3081000
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Tel Aviv, 6203854
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Tel Aviv, 6423906
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Tel Aviv, 6905234
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Tel Aviv, 6937947
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Tiberias, 1528001
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Tsrifin, 7030000
Mexico20 sites
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Aguascalientes, 20219
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Chihuahua City, 31238
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Cuernavaca, Morelos, 62250
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Culiacán, Sinaloa, 80200
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Culiacán, Sinaloa, 80230
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Durango, 34000
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Guadalajara, Jalisco, 44600
Study site
Guadalajara, Jalisco, 44657
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Mazatlán, Sinaloa, 82110
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Mexico City, Mexico City, 06729
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Mexico City, Mexico City, 11650
Study site
Mexico City, Mexico City, 6700
Study site
México D.F., Mexico City, 14080
Study site
México, D. F., Mexico City, 11850
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México, D. F., Mexico City, 3100
Study site
Monterrey, Nuevo León, 64460
Study site
Puerto de Veracruz, Veracruz, 91900
Study site
Querétaro City, Querétaro, 76000
Study site
San Juan del Río, Querétaro, 76800
Study site
Xalapa, Veracruz, 91193
Colombia19 sites
Study site
Armenia, Quindío Department, 0
Study site
Barranquilla, Atlántico, 0
Study site
Barranquilla, Atlántico
Study site
Barranquilla
Study site
Bogotá, Bogota D.C., 0
Study site
Bogotá, Bogota D.C.
Study site
Bogotá
Study site
Cali, Valle del Cauca Department, 760032
Study site
Cali, Valle del Cauca Department
Study site
Cundinamarca, Bogota D.C.
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Floridablanca
Study site
Manizales, Caldas Department
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Medellín, Antioquia, 050034
Study site
Medellín, Antioquia, 0
Study site
Medellín, Antioquia
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Medellín
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Pasto, Departamento de Nariño
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Pereira, Risaralda Department
Study site
Zipaquirá, Cundinamarca, 0
Romania19 sites
Study site
Alba Iulia, Alba, 510053
Study site
Baia Mare, Maramureş, 430222
Study site
Brasov, 500269
Study site
Bucharest, 010507
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Bucharest, 010627
Study site
Bucharest, 010825
Study site
Bucharest, 014142
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Bucharest, 020614
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Bucharest, 031818
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Bucharest, 050538
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Cluj-Napoca, 400006
Study site
Galati, 800001
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Iași, 700547
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Oradea, Bihor County, 410519
Study site
Oradea, 410159
Study site
Ploieşti, Prahova, 100179
Study site
Satu Mare, 440055
Study site
Timișoara, Timiș County, 300456
Study site
Timișoara, 300736
Bulgaria18 sites
Study site
Blagoevgrad, 2700
Study site
Botevgrad, 2140
Study site
Dimitrovgrad, 6400
Study site
Gorna Oryahovitsa, 5100
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Kazanlak, 6102
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Kozloduy, 3320
Study site
Lukovit, 5770
Study site
Plovdiv, 4002
Study site
Plovdiv, 4004
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Razgrad, 7200
Study site
Sliven, 8800
Study site
Sofia, 1233
Study site
Sofia, 1407
Study site
Sofia, 1606
Study site
Sofia, 1680
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Stara Zagora, 6000
Study site
Varna, 9000
Study site
Yambol, 8600
Portugal18 sites
Study site
Almada, 2801-951
Study site
Amadora, 2720-276
Study site
Braga, 4710-243
Study site
Covilha, Castelo Branco District, 6200-251
Study site
Faro, 8000-386
Study site
Funchal, Madeira, 9004-514
Study site
Leiria, 2410-197
Study site
Lisbon, 1069-166
Study site
Lisbon, 1250-189
Study site
Lisbon, 1449-005
Study site
Lisbon, 1500-650
Study site
Loures, Lisbon District, 2674-514
Study site
Matosinhos Municipality, Porto District, 4464-513
Study site
Porto, 4099-001
Study site
Porto, 4200-319
Study site
Setúbal, Setúbal District, 2900-446
Study site
Torres Novas, Santarém District, 2350-754
Study site
Viana do Castelo, 4901-858
South Africa17 sites
Study site
Benoni, Gauteng, 1501
Study site
Cape Town, Western Cape, 7570
Study site
Cape Town, Western Cape, 7925
Study site
Durban, KwaZulu-Natal, 4030
Study site
Isipingo Rail, KwaZulu-Natal, 4110
Study site
Johannesburg, Gauteng, 2198
Study site
Lenasia South, Gauteng, 1835
Study site
Middelburg, Mpumalanga, 1055
Study site
Newtown, Gauteng, 2113
Study site
Port Elizabeth, Eastern Cape, 6045
Study site
Pretoria, Gauteng, 0002
Study site
Pretoria, Gauteng, 0181
Study site
Somerset West, Western Cape, 7130
Study site
Soweto, Gauteng, 1818
Study site
Tongaat, KwaZulu-Natal, 4400
Study site
Witbank, Mpumalanga, 1035
Study site
Worcester, Western Cape, 6850
Australia16 sites
Study site
Adelaide, South Australia, 5000
Study site
Brisbane, Queensland, 4064
Study site
Elizabeth Vale, 5112
Study site
Fitzroy, Victoria, 3065
Study site
Garran, Australian Capital Territory, 2605
Study site
Gosford, New South Wales, 2250
Study site
Heidelberg, Victoria, 3081
Study site
Kanwal, New South Wales, 2259
Study site
Liverpool, New South Wales, 2170
Study site
Melbourne, Victoria, 3052
Study site
New Lambton Heights, New South Wales, 2305
Study site
Prahran, Victoria, 3181
Study site
Reservoir, Victoria, 3073
Study site
Richmond, Victoria, 3121
Study site
St Albans, Victoria, 3021
Study site
Wollongong, New South Wales, 2500
France16 sites
Study site
Bois-Guillaume, 76230
Study site
Boulogne-sur-Mer, 62321
Study site
Brest, 29200
Study site
Colmar, 68024
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Dijon, 21000
Study site
Grenoble, 38043
Study site
Le Coudray, 28630
Study site
Le Creusot, 71200
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Lyon, 69437
Study site
Mulhouse, 68051
Study site
Nîmes, 30029
Study site
Paris, 75018
Study site
Saint-Herblain, 44093
Study site
Tourcoing, 59280
Study site
Vandœuvre-lès-Nancy, 54500
Study site
Vénissieux, 69200
Denmark15 sites
Study site
Aalborg, 9000
Study site
Aarhus N, 8200
Study site
Esbjerg, 6700
Study site
Gentofte Municipality, 2730
Study site
Hellerup, 2900
Study site
Herlev, 2730
Study site
Hillerød, DK-3400
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Holbæk, 4300
Study site
Holstebro, DK-7500
Study site
Hvidovre, 2650
Study site
København NV, 2400
Study site
Kolding, 6000
Study site
Odense C, DK-5000
Study site
Svendborg, 5700
Study site
Viborg, 8800
Argentina14 sites
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1056ABJ
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1426ABP
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1428ART
Study site
Buenos Aires, Ciudad Auton. de Buenos Aires, C1429BWN
Study site
CABA, Buenos Aires, C1120AAC
Study site
CABA, Ciudad Auton. de Buenos Aires, C1018DES
Study site
Ciudad Autón. de Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AGC
Study site
Córdoba, X5000AAW Córdoba
Study site
Córdoba, X5000JHQ
Study site
Junín, Buenos Aires, B6000GMA
Study site
Lanus, Buenos Aires, B1824KAJ
Study site
Mar del Plata, Buenos Aires, B7602CBM
Study site
San Luis, D5702AAx
Study site
Sarandí, Buenos Aires, 1872
Turkey (Türkiye)14 sites
Study site
Ankara
Study site
Antalya, 07003
Study site
Antalya, 07059
Study site
Aydin, 09100
Study site
Istanbul, 34303
Study site
Istanbul, 34722
Study site
Istanbul, 34899
Study site
Izmir, 35100
Study site
Izmir, 35180
Study site
Izmir, 35540
Study site
Kayseri, 38039
Study site
Kocaeli, 41380
Study site
Malatya, 44280
Study site
Sivas, 58140
Austria13 sites
Study site
Feldkirch, Vorarlberg, 6807
Study site
Graz, Styria, 8036
Study site
Innsbruck, 6020
Study site
Linz, Upper Austria, 4020
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Linz, Upper Austria, 4021
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Saint Stefan, Styria, 8511
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Salzburg, 5020
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Vienna, 1030
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Vienna, 1060
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Vienna, 1090
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Vienna, 1130
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Wels, 4600
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Zams, Tyrol, 6511
Netherlands13 sites
Study site
Alkmaar, 1815 JD
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Almere Stad, 1315 RA
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Amersfoort, 3818 TZ
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Amsterdam, 1091 AC
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Amsterdam, 1105 AZ
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Apeldoorn, 7334 DZ
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Breda, 4818 CK
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Eindhoven, 5600 PD
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Geleen, 6162 BG
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Groningen, 9713 GZ
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Hoogeveen, 7909 AA
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The Hague, 2545 CH
Study site
Zwijndrecht, 3331 LZ
South Korea13 sites
Study site
Anyang-si, Gyeonggido, 14068
Study site
Busan, 49241
Study site
Daegu, 42601
Study site
Seongnam-si, Gyeonggido, 13620
Study site
Seoul, Seoul Teugbyeolsi, 03080
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Seoul, 02841
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Seoul, 03722
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Seoul, 05278
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Seoul, 05505
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Seoul, 06351
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Seoul, 07441
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Seoul, 110-746
Study site
Wŏnju, Gang''weondo, 26426
Sweden13 sites
Study site
Gothenburg, 413 45
Study site
Gothenburg, 413 46
Study site
Lund, 221 85
Study site
Lund, 222 21
Study site
Örebro, 701 85
Study site
Örebro, 703 62
Study site
Rättvik, 795 30
Study site
Skövde, 541 50
Study site
Stockholm, 113 24
Study site
Stockholm, 114 46
Study site
Stockholm, 182 88
Study site
Uppsala, 751 85
Study site
Uppsala, 752 37
Finland12 sites
Study site
Jyväskylä, 40620
Study site
Kajaani, 87140
Study site
Kerava, 04200
Study site
Klaukkala, 01800
Study site
Kuopio, 70100
Study site
Nurmijärvi, 01900
Study site
Oulu, 90100
Study site
Rauma, 26100
Study site
Seinäjoki, 60100
Study site
Tampere, 33520
Study site
Turku, 20521
Study site
Vantaa, 01600
United Kingdom12 sites
Study site
Birmingham, West Midlands, B15 2SQ
Study site
Bristol, BS10 5NB
Study site
Carshalton, Surrey, SM5 1AA
Study site
Chichester, West Sussex, PO19 6SE
Study site
Glasgow, G20 OSP
Study site
Liverpool, Merseyside, L7 8XP
Study site
Llanelli, Carmarthenshire, SA14 8QF
Study site
London, E1 1BB
Study site
London, SE5 9RS
Study site
Manchester, M8 5RB
Study site
Middlesbrough, TS4 3BW
Study site
Northampton, Northamptonshire, NN1 5BD
Norway11 sites
Study site
Ålesund, 6017
Study site
Hamar, 2317
Study site
Hamar
Study site
Kløfta, 2040
Study site
Kongsvinger
Study site
Kristiansand, 4604
Study site
Levanger, 7601
Study site
Lierskogen, 3420
Study site
Oslo, 0176
Study site
Oslo, 0586
Study site
Skedsmokorset, 2020
Malaysia10 sites
Study site
Johor Bahru, 80100
Study site
Kelantan, 15200
Study site
Kelantan
Study site
Kuala Lumpur, 59100
Study site
Kuala Pahang, 25100
Study site
Kuala Selangor, 47000
Study site
Perak, 30450
Study site
Perak, 32040
Study site
Pulau Pinang, 10450
Study site
Putrajaya, 62250
Chile9 sites
Study site
Las Condes, Santiago Metropolitan, 7591047
Study site
Osorno, Los Lagos Region, 5311092
Study site
Providencia, Santiago Metropolitan, 7500520
Study site
Providencia, Santiago Metropolitan, 7500922
Study site
San Bernardo, Santiago Metropolitan, 8053095
Study site
San Miguel, Santiago Metropolitan, 8910108
Study site
Santiago, 7500710
Study site
Santiago, 8331143
Study site
Santiago, 8380456
Taiwan9 sites
Study site
Changhua, 50006
Study site
Kaohsiung City, 833
Study site
New Taipei City, 220
Study site
Taichung, 40447
Study site
Taichung, 40705
Study site
Taipei, 100
Study site
Taipei, 110
Study site
Taipei, 11217
Study site
Taoyuan, 33305
Belgium8 sites
Study site
Bruxelles - Brussel, 1070
Study site
Edegem, 2650
Study site
Ghent, 9000
Study site
Ieper, 8900
Study site
Kortrijk, 8500
Study site
Leuven, 3000
Study site
Liège, 4000
Study site
Roeselare, 8800
Greece8 sites
Study site
Alexandroupoli, 68100
Study site
Athens, 11527
Study site
Athens, 14455
Study site
Chaïdári, 12462
Study site
Larissa, 41100
Study site
Nea Ionia, 14233
Study site
Thessaloniki, 54642
Study site
Thessaloniki, 56403
New Zealand8 sites
Study site
Auckland, 2025
Study site
Auckland
Study site
Christchurch, 8011
Study site
Hamilton, 3204
Study site
Hawkes Bay, 4130
Study site
Palmerston North, 4414
Study site
Tauranga, 3110
Study site
Wellington
Lithuania7 sites
Study site
Kaunas, LT-45217
Study site
Kaunas, LT-48259
Study site
Kaunas, LT-49449
Study site
Kaunas, LT-51270
Study site
Klaipėda, LT-92304
Study site
Utena, LT-28142
Study site
Vilnius, LT-08661
Philippines6 sites
Study site
Iloilo City, 5000
Study site
Marikina City
Study site
Pasig, 1600
Study site
Quezon City, 1102
Study site
Quezon City, 1110
Study site
Quezon City, 1112
Slovakia6 sites
Study site
Banská Bystrica, 974 01
Study site
Bardejov, 085 01
Study site
Nitra, 949 11
Study site
Rimavská Sobota, 979 01
Study site
Rožňava, 048 01
Study site
Žilina, 01001
Switzerland6 sites
Study site
Bern, 3010
Study site
Geneva, 1205
Study site
Lausanne, Canton of Vaud, 1011
Study site
Olten, Canton of Solothurn, 4600
Study site
Sankt Gallen, Canton of St. Gallen, 9007
Study site
Sankt Gallen, Canton of St. Gallen, 9016
Vietnam5 sites
Study site
Hà Nội, 10000
Study site
Hà Nội
Study site
Ho Chi Minh City, 70000
Study site
Ho Chi Minh City, 84
Study site
Ho Chi Minh City
Hong Kong4 sites
Study site
Hong Kong
Study site
Shatin
Study site
Sheung Wan
Study site
Wong Tai Sin
Thailand4 sites
Study site
Bangkok, 10400
Study site
Bangkok
Study site
Chiang Mai, 50200
Study site
Khon Kaen, 40002
Puerto Rico3 sites
Study site
Cidra, 00739
Study site
San Juan, 00909-3004
Study site
San Juan, 00917
Singapore3 sites
Study site
Singapore, 169608
Study site
Singapore, 169609
Study site
Singapore, 768828
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Finerenone (BAY94-8862), Placebo
- Keywords
- Type 2 Diabetes, Kidney diseases
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Type 2, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finerenone (BAY94-8862)Drug
10 mg or 20 mg Finerenone tablet to be given orally, once daily.
PlaceboDrug
Matching placebo to be taken orally, once daily.
| Study group | Role | What they receive |
|---|---|---|
| BAY94-8862 | Experimental | Finerenone tablet Receives: Drug: Finerenone (BAY94-8862) |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure.
Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result.
Measured: From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
Secondary outcomes (5)
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death.
Number of participants with first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were reported as descriptive result.
Measured: From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
All-cause Hospitalization
Number of participants with first occurrence of a hospitalization event were reported as descriptive result.
Measured: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average study duration of 41 months
All-cause Mortality
Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.
Measured: From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 months
Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4
First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change.
Measured: From baseline up until Month 4
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death
Number of participants with first occurrence of the renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were reported as descriptive result.
Measured: From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start17 Sep 2015
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545049
- Sponsor's protocol ID
- 17530
- Other IDs
- 2015-000950-39, 2015
- Acronym
- FIGARO-DKD
- Status last verified
- Apr 2022
- First submitted
- 2 Sep 2015
- Last updated
- 15 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
Ruilope LM, Agarwal R, Anker SD, Bakris GL, Filippatos G, Nowack C, Kolkhof P, Joseph A, Mentenich N, Pitt B; FIGARO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):345-356. doi: 10.1159/000503712. Epub 2019 Oct 30.
PubMed 31665733Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.
PubMed 34449181Lo KB, Ostrominski JW, Hamatani Y, Claggett BL, Agarwal R, Anker SD, Filippatos G, Rossing P, Ruilope LM, Pitt B, Briasoulis A, Stamatelopoulos K, Brinker M, Schloemer P, Glasauer A, Solomon SD, Vaduganathan M. Finerenone Across Cardiovascular-Kidney-Metabolic Syndrome Stages: Post Hoc Analysis of the FIDELITY Randomized Clinical Trials. JAMA Cardiol. 2026 Jul 1;11(7):679-684. doi: 10.1001/jamacardio.2026.1365.
PubMed 42234437Mielke J, Strunz T, Lee J, Schloemer P; GCKD Investigators; Gallone G. An integrative framework for drug target discovery bridging clinical trial and genetic data insights. J Transl Med. 2026 Mar 13;24(1):374. doi: 10.1186/s12967-026-07806-x.
PubMed 41827014Weingold R, Filippatos G, Anker SD, Wanner C, Shafi T, Tangri N, Pitt B, Brinker M, Scott C, Roberts L, Rossing P, Inzucchi SE; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone increases the likelihood of improved KDIGO risk category in patients with CKD and type 2 diabetes: An analysis from FIDELITY. J Diabetes Complications. 2026 Apr;40(4):109274. doi: 10.1016/j.jdiacomp.2026.109274. Epub 2026 Jan 31.
PubMed 41679125Munoz Mendoza J, Weir MR, Anker SD, Filippatos G, Rossing P, Ahlers C, Brinker M, Fatoba ST, Horvat-Broecker A, Rohwedder K, Fornoni A; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone in People with CKD, Type 2 Diabetes, and History of Nephrectomy. Clin J Am Soc Nephrol. 2026 Mar 1;21(3):414-424. doi: 10.2215/CJN.0000000932. Epub 2026 Jan 14.
PubMed 41533467Katayama S, Anker SD, Zhu D, Kim S, Wu MJ, Kawanami D, Rossing P, Ruilope LM, Ahlers C, Brinker M, Mann A, Tian Y, Yamashita S, Pitt B; FIDELIO-DKD and FIGARO-DKD Investigators. Efficacy and safety of finerenone in Asian patients with type 2 diabetes and chronic kidney disease: A FIDELITY analysis by baseline kidney function. J Diabetes Complications. 2026 Jan;40(1):109213. doi: 10.1016/j.jdiacomp.2025.109213. Epub 2025 Nov 4.
PubMed 41289823Ferreira JP, Mendonca L, Marques P, Neves JS, Zannad F, Packer M. Albuminuria Is the Key Driver of Kidney Benefit with Aldosterone Receptor Antagonists in Type 2 Diabetes. J Am Soc Nephrol. 2026 Feb 1;37(2):390-393. doi: 10.1681/ASN.0000000877. Epub 2025 Sep 2. No abstract available.
PubMed 40892478Rossing P, Birkenfeld AL, Fioretto P, McGill JB, Anker SD, Pitt B, Rohwedder K, Scalise A, Scott C, Filippatos G; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone and Clinical Outcomes in CKD and Type 2 Diabetes by Frailty Index: FIDELITY Post Hoc Analysis. Clin J Am Soc Nephrol. 2025 May 2;20(7):968-977. doi: 10.2215/CJN.0000000700.
PubMed 40315020Singh AK, James G, Anker SD, Pitt B, Rossing P, Ruilope LM, Farjat AE, Farag YMK, Roberts L, Filippatos G; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone Efficacy in Patients with Chronic Kidney Disease, Type 2 Diabetes, and Anemia in FIDELITY. JACC Adv. 2025 Feb;4(2):101524. doi: 10.1016/j.jacadv.2024.101524.
PubMed 40021271Pitt B, Agarwal R, Anker SD, Rossing P, Ruilope L, Herzog CA, Greenberg B, Pecoits-Filho R, Lambelet M, Lawatscheck R, Scalise A, Filippatos G. Hypokalaemia in patients with type 2 diabetes and chronic kidney disease: the effect of finerenone-a FIDELITY analysis. Eur Heart J Cardiovasc Pharmacother. 2025 Feb 8;11(1):10-19. doi: 10.1093/ehjcvp/pvae074.
PubMed 39380152Bansal S, Canziani MEF, Birne R, Anker SD, Bakris GL, Filippatos G, Rossing P, Ruilope LM, Farjat AE, Kolkhof P, Lage A, Brinker M, Pitt B. Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials. BMJ Open. 2024 Mar 19;14(3):e076444. doi: 10.1136/bmjopen-2023-076444.
PubMed 38508632Agarwal R, Tu W, Farjat AE, Farag YMK, Toto R, Kaul S, Lawatscheck R, Rohwedder K, Ruilope LM, Rossing P, Pitt B, Filippatos G, Anker SD, Bakris GL; FIDELIO-DKD and FIGARO-DKD Investigators. Impact of Finerenone-Induced Albuminuria Reduction on Chronic Kidney Disease Outcomes in Type 2 Diabetes : A Mediation Analysis. Ann Intern Med. 2023 Dec;176(12):1606-1616. doi: 10.7326/M23-1023. Epub 2023 Dec 5.
PubMed 38048573Flack JM, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Adler SG, Fried L, Jamerson K, Toto R, Brinker M, Farjat AE, Kolkhof P, Lawatscheck R, Joseph A, Bakris GL; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone in Black Patients With Type 2 Diabetes and CKD: A Post hoc Analysis of the Pooled FIDELIO-DKD and FIGARO-DKD Trials. Kidney Med. 2023 Sep 28;5(12):100730. doi: 10.1016/j.xkme.2023.100730. eCollection 2023 Dec.
PubMed 38046911Rosas SE, Ruilope LM, Anker SD, Pitt B, Rossing P, Bonfanti AAC, Correa-Rotter R, Gonzalez F, Munoz CFJ, Pergola P, Umpierrez GE, Scalise A, Scott C, Lawatscheck R, Joseph A, Bakris GL; FIDELIO-DKD and FIGARO-DKD investigators. Finerenone in Hispanic Patients With CKD and Type 2 Diabetes: A Post Hoc FIDELITY Analysis. Kidney Med. 2023 Aug 1;5(10):100704. doi: 10.1016/j.xkme.2023.100704. eCollection 2023 Oct.
PubMed 37745646
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.
- ClinicalTrials.gov ID
- NCT02545049
- Acronym / sponsor ID
- FIGARO-DKD / 17530
- Conditions
- Diabetic Kidney Disease
- Keywords
- Type 2 Diabetes, Kidney diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,352 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 9 Sep 2015 (estimated)
- Results
- Posted 15 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAY94-8862 | Experimental | Drug: Finerenone (BAY94-8862)Finerenone tablet |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women ≥18 years of age
- Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes Association
- Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
- Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
- Serum potassium <=4.8 mmol/L
Key exclusion criteria (6 listed)
- Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis
- Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)
- Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit [class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)]
- Dialysis for acute renal failure within 12 weeks of Run-in visit
- Renal allograft in place or scheduled kidney transplant within next 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finerenone (BAY94-8862)10 mg or 20 mg Finerenone tablet to be given orally, once daily. | Drug | BAY94-8862 |
| PlaceboMatching placebo to be taken orally, once daily. | Drug | Placebo |
Primary outcome
The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure.
Time frame: From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result.
5 secondary outcomes
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death.
Time frame: From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
All-cause Hospitalization
Time frame: From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average study duration of 41 months
All-cause Mortality
Time frame: From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 months
Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4
Time frame: From baseline up until Month 4
The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death
Time frame: From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31665733Ruilope LM, Agarwal R, Anker SD, Bakris GL, Filippatos G, Nowack C, Kolkhof P, Joseph A, Mentenich N, Pitt B; FIGARO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):345-356. doi: 10.1159/000503712. Epub 2019 Oct 30.
- Results publication: PubMed 34449181Pitt B, Filippatos G, Agarwal R, Anker SD, Bakris GL, Rossing P, Joseph A, Kolkhof P, Nowack C, Schloemer P, Ruilope LM; FIGARO-DKD Investigators. Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes. N Engl J Med. 2021 Dec 9;385(24):2252-2263. doi: 10.1056/NEJMoa2110956. Epub 2021 Aug 28.
- Derived from this study: PubMed 42234437Lo KB, Ostrominski JW, Hamatani Y, Claggett BL, Agarwal R, Anker SD, Filippatos G, Rossing P, Ruilope LM, Pitt B, Briasoulis A, Stamatelopoulos K, Brinker M, Schloemer P, Glasauer A, Solomon SD, Vaduganathan M. Finerenone Across Cardiovascular-Kidney-Metabolic Syndrome Stages: Post Hoc Analysis of the FIDELITY Randomized Clinical Trials. JAMA Cardiol. 2026 Jul 1;11(7):679-684. doi: 10.1001/jamacardio.2026.1365.
- Derived from this study: PubMed 41827014Mielke J, Strunz T, Lee J, Schloemer P; GCKD Investigators; Gallone G. An integrative framework for drug target discovery bridging clinical trial and genetic data insights. J Transl Med. 2026 Mar 13;24(1):374. doi: 10.1186/s12967-026-07806-x.
- Derived from this study: PubMed 41679125Weingold R, Filippatos G, Anker SD, Wanner C, Shafi T, Tangri N, Pitt B, Brinker M, Scott C, Roberts L, Rossing P, Inzucchi SE; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone increases the likelihood of improved KDIGO risk category in patients with CKD and type 2 diabetes: An analysis from FIDELITY. J Diabetes Complications. 2026 Apr;40(4):109274. doi: 10.1016/j.jdiacomp.2026.109274. Epub 2026 Jan 31.
- Derived from this study: PubMed 41533467Munoz Mendoza J, Weir MR, Anker SD, Filippatos G, Rossing P, Ahlers C, Brinker M, Fatoba ST, Horvat-Broecker A, Rohwedder K, Fornoni A; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone in People with CKD, Type 2 Diabetes, and History of Nephrectomy. Clin J Am Soc Nephrol. 2026 Mar 1;21(3):414-424. doi: 10.2215/CJN.0000000932. Epub 2026 Jan 14.
- Derived from this study: PubMed 41289823Katayama S, Anker SD, Zhu D, Kim S, Wu MJ, Kawanami D, Rossing P, Ruilope LM, Ahlers C, Brinker M, Mann A, Tian Y, Yamashita S, Pitt B; FIDELIO-DKD and FIGARO-DKD Investigators. Efficacy and safety of finerenone in Asian patients with type 2 diabetes and chronic kidney disease: A FIDELITY analysis by baseline kidney function. J Diabetes Complications. 2026 Jan;40(1):109213. doi: 10.1016/j.jdiacomp.2025.109213. Epub 2025 Nov 4.
- Derived from this study: PubMed 40892478Ferreira JP, Mendonca L, Marques P, Neves JS, Zannad F, Packer M. Albuminuria Is the Key Driver of Kidney Benefit with Aldosterone Receptor Antagonists in Type 2 Diabetes. J Am Soc Nephrol. 2026 Feb 1;37(2):390-393. doi: 10.1681/ASN.0000000877. Epub 2025 Sep 2. No abstract available.
- Derived from this study: PubMed 40315020Rossing P, Birkenfeld AL, Fioretto P, McGill JB, Anker SD, Pitt B, Rohwedder K, Scalise A, Scott C, Filippatos G; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone and Clinical Outcomes in CKD and Type 2 Diabetes by Frailty Index: FIDELITY Post Hoc Analysis. Clin J Am Soc Nephrol. 2025 May 2;20(7):968-977. doi: 10.2215/CJN.0000000700.
- Derived from this study: PubMed 40021271Singh AK, James G, Anker SD, Pitt B, Rossing P, Ruilope LM, Farjat AE, Farag YMK, Roberts L, Filippatos G; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone Efficacy in Patients with Chronic Kidney Disease, Type 2 Diabetes, and Anemia in FIDELITY. JACC Adv. 2025 Feb;4(2):101524. doi: 10.1016/j.jacadv.2024.101524.
- Derived from this study: PubMed 39380152Pitt B, Agarwal R, Anker SD, Rossing P, Ruilope L, Herzog CA, Greenberg B, Pecoits-Filho R, Lambelet M, Lawatscheck R, Scalise A, Filippatos G. Hypokalaemia in patients with type 2 diabetes and chronic kidney disease: the effect of finerenone-a FIDELITY analysis. Eur Heart J Cardiovasc Pharmacother. 2025 Feb 8;11(1):10-19. doi: 10.1093/ehjcvp/pvae074.
- Derived from this study: PubMed 38508632Bansal S, Canziani MEF, Birne R, Anker SD, Bakris GL, Filippatos G, Rossing P, Ruilope LM, Farjat AE, Kolkhof P, Lage A, Brinker M, Pitt B. Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials. BMJ Open. 2024 Mar 19;14(3):e076444. doi: 10.1136/bmjopen-2023-076444.
- Click here to find information about studies related to Bayer Healthcare products conducted in Europe.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, time point and process of data access. As such, Bayer commits to sharing upon request from qualified researcher's patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
975 sites in 48 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Finerenone (BAY94-8862) in people with Diabetic Kidney Disease, run by Bayer at 975 sites in 48 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 975 sites in United States, Japan, China, Russia, Germany and 43 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. (time frame: From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02545049, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.