A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.
NCT ID: NCT06268873
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
2546 participants
INTERVENTIONAL
2024-03-29
2028-02-24
Brief Summary
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This study consists of a screening, a 4-week dapagliflozin run-in period for participants untreated with SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin; and approximately 12-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 12-weeks (approximately), where reassessment of eGFR will occur for the primary efficacy endpoint.
In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Baxdrostat/dapagliflozin
Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
Baxdrostat/dapagliflozin
baxdrostat tablet
dapagliflozin tablet
Dapagliflozin
Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily
Dapagliflozin in combination with placebo
dapagliflozin tablet
placebo tablet
Interventions
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Baxdrostat/dapagliflozin
baxdrostat tablet
dapagliflozin tablet
Dapagliflozin in combination with placebo
dapagliflozin tablet
placebo tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants with CKD and eGFR ≥ 30 and \< 90 mL/min/1.73 m2 at screening
3. Urine albumin creatinine ratio \> 200 mg/g (22.6 mg/mmol) and \< 5000 mg/g (565 mg/mmol) at screening
4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
5. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
6. Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:
* for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
* for participants with screening eGFR \< 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit
Exclusion Criteria
2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
3. Serum sodium \< 135 mmol/L at the Screening Visit, determined as per central laboratory.
4. Diabetes mellitus:
(a) T1DM at Screening Visit: (i) For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.
(ii) For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.
(b) Uncontrolled T2DM at screening: HbA1C \> 10.5% (\> 91 mmol/mol).
5. New York Heart Association functional HF class IV at screening.
6. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.
7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
8. Any acute kidney injury within 3 months prior to the Screening Visit
9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
12. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Fairhope, Alabama, United States
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Phoenix, Arizona, United States
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Surprise, Arizona, United States
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Tucson, Arizona, United States
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Searcy, Arkansas, United States
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Beverly Hills, California, United States
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Canyon Country, California, United States
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Fremont, California, United States
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Fullerton, California, United States
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Lincoln, California, United States
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Los Alamitos, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Tarzana, California, United States
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Arvada, Colorado, United States
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Denver, Colorado, United States
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New Britain, Connecticut, United States
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Boca Raton, Florida, United States
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Boynton Beach, Florida, United States
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Edgewater, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Lake City, Florida, United States
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Lake Worth, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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New Port Richey, Florida, United States
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Ocoee, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Port Charlotte, Florida, United States
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Port Orange, Florida, United States
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Riverview, Florida, United States
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Winter Haven, Florida, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, United States
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Macon, Georgia, United States
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Champaign, Illinois, United States
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Hazel Crest, Illinois, United States
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Huntley, Illinois, United States
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Rockford, Illinois, United States
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Evansville, Indiana, United States
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Fort Wayne, Indiana, United States
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Hutchinson, Kansas, United States
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Wichita, Kansas, United States
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Bethesda, Maryland, United States
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Lanham, Maryland, United States
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Boston, Massachusetts, United States
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New Bedford, Massachusetts, United States
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Detroit, Michigan, United States
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Pontiac, Michigan, United States
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Saint Joseph, Michigan, United States
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City of Saint Peters, Missouri, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Eatontown, New Jersey, United States
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Binghamton, New York, United States
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Manhasset, New York, United States
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Middletown, New York, United States
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New York, New York, United States
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Niagara Falls, New York, United States
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Orchard Park, New York, United States
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Rockville Centre, New York, United States
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Greenville, North Carolina, United States
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Jacksonville, North Carolina, United States
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New Bern, North Carolina, United States
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Maumee, Ohio, United States
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Chester, Pennsylvania, United States
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Langhorne, Pennsylvania, United States
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Uniontown, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Sioux Falls, South Dakota, United States
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Chattanooga, Tennessee, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Arlington, Virginia, United States
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Manassas, Virginia, United States
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Newport News, Virginia, United States
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Salem, Virginia, United States
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Woodbridge, Virginia, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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Ciudad Autonoma de Bs As, , Argentina
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Clayton, , Australia
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Gosford, , Australia
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Perth, , Australia
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Aalst, , Belgium
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Bonheiden, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Ieper, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Ronse, , Belgium
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Belém, , Brazil
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Campinas, , Brazil
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Foshan, , China
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Guiyang, , China
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Haikou, , China
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Hangzhou, , China
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Hengyang, , China
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Huai'an, , China
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Lanzhou, , China
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Nanjing, , China
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Ningbo, , China
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Panjin, , China
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Pingxiang, , China
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Sanya, , China
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Wuhan, , China
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Xi'an, , China
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Xiamen, , China
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Yantai, , China
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Yinchuan, , China
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Zhengzhou, , China
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Frýdek-Místek, , Czechia
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Jilemnice, , Czechia
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Krnov, , Czechia
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Náchod, , Czechia
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Olomouc, , Czechia
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Police nad Metují, , Czechia
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Prague, , Czechia
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Třebíč, , Czechia
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Aalborg, , Denmark
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Aarhus, , Denmark
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Copenhagen E, , Denmark
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Esbjerg, , Denmark
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Herlev, , Denmark
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Herning, , Denmark
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Holbæk, , Denmark
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Amiens, , France
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Annonay, , France
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Bois-Guillaume, , France
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Brest, , France
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Clermont-Ferrand, , France
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La Roche-sur-Yon, , France
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Le Puy-en-Velay, , France
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Lille, , France
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Marseille, , France
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Nîmes, , France
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Paris, , France
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Poitiers, , France
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Quimper, , France
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Sarcelles, , France
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Toulouse, , France
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Tours, , France
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Valenciennes, , France
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Vandœuvre-lès-Nancy, , France
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Aachen, , Germany
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Amberg, , Germany
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Bad Oeynhausen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Dresden, , Germany
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Essen, , Germany
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Falkensee, , Germany
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Hamburg, , Germany
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Herne, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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München, , Germany
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Münster, , Germany
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Nuremberg, , Germany
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Oldenburg, , Germany
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Reinfeld (Holstein), , Germany
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Ulm, , Germany
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Völklingen, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Heraklion, , Greece
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Ioannina, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Kecskemét, , Hungary
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Nyíregyháza, , Hungary
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Pécs, , Hungary
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Pécs, , Hungary
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Siófok, , Hungary
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Székesfehérvár, , Hungary
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Bangalore, , India
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Belagavi, , India
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Calicut, , India
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Chennai, , India
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Coimbatore, , India
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Dehradun, , India
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Hyderabad, , India
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Kolkata, , India
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Madurai, , India
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New Delhi, , India
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New Delhi, , India
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Pune, , India
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Vijayawada, , India
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Ashkelon, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Bologna, , Italy
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Catanzaro, , Italy
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Chiavari, , Italy
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Desio, , Italy
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Milan, , Italy
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Napoli, , Italy
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Parma, , Italy
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Rozzano, , Italy
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San Giovanni Rotondo, , Italy
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Torino, , Italy
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Chūōku, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Daito-shi, , Japan
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Fujisawa-shi, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Osaka, , Japan
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Ōita, , Japan
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Tsu, , Japan
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Urayasu, , Japan
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Yaizu-shi, , Japan
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Yokohama, , Japan
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Klang, , Malaysia
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Kota Kinabalu, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuantan, , Malaysia
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Seremban, , Malaysia
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Taiping, , Malaysia
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Alkmaar, , Netherlands
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Amersfoort, , Netherlands
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Dordrecht, , Netherlands
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Hardenberg, , Netherlands
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Utrecht, , Netherlands
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Piura, , Peru
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Iloilo City, , Philippines
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Laguna, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Chrzanów, , Poland
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Gdynia, , Poland
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Iași, , Romania
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Oradea, , Romania
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Timișoara, , Romania
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Dammam, , Saudi Arabia
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Belgrade, , Serbia
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Niš, , Serbia
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Novi Sad, , Serbia
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Banská Bystrica, , Slovakia
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Lučenec, , Slovakia
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Martin, , Slovakia
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Myjava, , Slovakia
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Nitra, , Slovakia
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Nitra, , Slovakia
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Prešov, , Slovakia
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Púchov, , Slovakia
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Rožňava, , Slovakia
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Žilina, , Slovakia
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Benoni, , South Africa
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Cape Town, , South Africa
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Durban, , South Africa
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Newton, , South Africa
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Busan, , South Korea
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Gwangju, , South Korea
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Uijeongbu-si, , South Korea
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Wŏnju, , South Korea
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Yangsan, , South Korea
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A Coruña, , Spain
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Almería, , Spain
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Badalona, , Spain
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L'Hospitalet de Llobregat, , Spain
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Lugo, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Palma deMallorca, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Valencia, , Spain
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Danderyd, , Sweden
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Gävle, , Sweden
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Gothenburg, , Sweden
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Linköping, , Sweden
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Rättvik, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Yung Kang City, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Hat Yai, , Thailand
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Muang, , Thailand
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Phutthamonthon, , Thailand
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Ratchathewi, , Thailand
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Ubonratchathani, , Thailand
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Adana, , Turkey (Türkiye)
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Adapazarı, , Turkey (Türkiye)
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Afyonkarahisar, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Antalya, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kahramanmaraş, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Chernivtsі, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Ternopil, , Ukraine
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Ternopil, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Bristol, , United Kingdom
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Cambridge, , United Kingdom
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Dundee, , United Kingdom
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Glasgow, , United Kingdom
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Harrow, , United Kingdom
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Hounslow, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newcastle-under-Lyme, , United Kingdom
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Nottingham, , United Kingdom
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Wolverhampton, , United Kingdom
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Can Tho, , Vietnam
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Can Tho, , Vietnam
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Da Nang, , Vietnam
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Haiphong, , Vietnam
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Ho Chi Minh City, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hochiminh City, , Vietnam
Countries
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References
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Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2025 Sep 6. doi: 10.1681/ASN.0000000849. Online ahead of print. No abstract available.
Other Identifiers
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2023-506457-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D6972C00003
Identifier Type: -
Identifier Source: org_study_id
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