A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Start Date
3/3/2025
Completion Date
12/18/2029
Summary
International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure
Detailed Description
The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, HF events, or CV death in participants with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred (N = 845) ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within 6 weeks of the PACD. This period can be extended by AstraZeneca. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. Baxdrostat/placebo should not be administered without dapagliflozin: baxdrostat/placebo should be interrupted if dapagliflozin is interrupted (baxdrostat/placebo may be resumed with dapagliflozin, if dapagliflozin is resumed), and should be permanently discontinued if dapagliflozin is permanently discontinued. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Baxdrostat/dapagliflozin
Placebo/dapagliflozin
Conditions
Locations
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Fairhope, Alabama 36532
United States
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Surprise, Arizona 85374
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Tucson, Arizona 85710
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Beverly Hills, California 90211
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Canoga Park, California 91303
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Concord, California 94520
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Fremont, California 94538
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Fullerton, California 92835
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Inglewood, California 90301
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Los Alamitos, California 90720
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Los Angeles, California 90073
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San Diego, California 92120
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San Francisco, California 94110
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Stanford, California 94305
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Tarzana, California 91356
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Arvada, Colorado 80002
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Denver, Colorado 80220
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New Britain, Connecticut 06051
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Washington D.C., District of Columbia 20037
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Boca Raton, Florida 33487
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Boynton Beach, Florida 33435
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Edgewater, Florida 32132
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Fort Lauderdale, Florida 33316
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Hollywood, Florida 33021
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Jacksonville Beach, Florida 32250
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Lake City, Florida 32055
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Lakeland, Florida 33805
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Melbourne, Florida 32901
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Miami Lakes, Florida 33014
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Ocoee, Florida 34761
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Port Charlotte, Florida 33952
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Port Orange, Florida 32127
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Riverview, Florida 33578
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Atlanta, Georgia 30328
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Atlanta, Georgia 30344
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Augusta, Georgia 30904
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Austell, Georgia 30106
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Brunswick, Georgia 31520
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Conyers, Georgia 30094
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Decatur, Georgia 30030
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Lawrenceville, Georgia 30046
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Riverdale, Georgia 30274
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Honolulu, Hawaii 96814
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Idaho Falls, Idaho 83402
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Champaign, Illinois 61822
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Maywood, Illinois 60153
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Rockford, Illinois 61107
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Evansville, Indiana 47714
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Indianapolis, Indiana 46202
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Iowa City, Iowa 52242
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West Des Moines, Iowa 50266
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Hutchinson, Kansas 67502
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Kansas City, Kansas 66112
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Wichita, Kansas 67214
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Kenner, Louisiana 70065
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Metairie, Louisiana 70006
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West Monroe, Louisiana 71291
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Bethesda, Maryland 20889
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Boston, Massachusetts 02114
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Boston, Massachusetts 02115
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Braintree, Massachusetts 02184
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New Bedford, Massachusetts 02740
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Worcester, Massachusetts 01608
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Ann Arbor, Michigan 48109
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Detroit, Michigan 48202
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Garden City, Michigan 48135
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Saint Joseph, Michigan 49085
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Kansas City, Missouri 64111
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Kansas City, Missouri 64151
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St Louis, Missouri 63136
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Norfolk, Nebraska 68701
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Las Vegas, Nevada 89109
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Eatontown, New Jersey 07724
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Albany, New York 12205
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Buffalo, New York 14203
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New York, New York 10016
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Greenville, North Carolina 27834
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Hickory, North Carolina 28601
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Jacksonville, North Carolina 28546
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Kinston, North Carolina 28504
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Morehead City, North Carolina 28557
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New Bern, North Carolina 28562
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Raleigh, North Carolina 27609
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Rocky Mount, North Carolina 27804
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Sanford, North Carolina 27330
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Statesville, North Carolina 28625
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Wilmington, North Carolina 28401
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Wilmington, North Carolina 28412
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Winston-Salem, North Carolina 27103
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Canton, Ohio 44718
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Cincinnati, Ohio 45212
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Cincinnati, Ohio 45219
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Columbus, Ohio 43210
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Columbus, Ohio 43213
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Columbus, Ohio 43215
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Springfield, Oregon 97477
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Bridgeville, Pennsylvania 15017
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Butler, Pennsylvania 16001
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Exton, Pennsylvania 19341
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Langhorne, Pennsylvania 19047
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Media, Pennsylvania 19063
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East Providence, Rhode Island 02914
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East Providence, Rhode Island 02915
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Providence, Rhode Island 02904
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Charleston, South Carolina 29414
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Columbia, South Carolina 29203
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Orangeburg, South Carolina 29118
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Chattanooga, Tennessee 37421
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Knoxville, Tennessee 37912
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Knoxville, Tennessee 37938
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Nashville, Tennessee 37232
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Arlington, Texas 76015
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Austin, Texas 78726
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Austin, Texas 78735
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Dallas, Texas 75234
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Arlington, Virginia 22205
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Mar del Plata, 7600
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Adelaide, 5000
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Darlinghurst, 2010
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Elizabeth Vale, 5112
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Gosford, 2250
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Aalst, 9300
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Brussels, 1200
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Genk, 3600
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Hasselt, 3500
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Ieper, 8900
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Jette, 1090
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Kortrijk, 8500
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Leuven, 3000
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Liège, 4000
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Mechelen, 2800
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Namur, 5000
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Roeselare, 8800
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Ronse, 9600
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Sint-Truiden, 3800
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Barretos, 14784-400
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Belém, 66073-005
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Brasília, 70200-730
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Campina Grande do Sul, 83.430-000
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Campinas, 13060-080
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Campinas, 13060-904
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Curitiba, 80230-130
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Fortaleza, 60175-047
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Byala, 7100
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Dupnitsa, 2600
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Gabrovo, 5300
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Gotse Delchev, 2900
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Kozloduy, 3320
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Lom, 3600
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Pernik, 2300
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Plovdiv, 4004
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Rousse, 7013
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Sandanski, 2800
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Sevlievo, 5403
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Sliven, 8800
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Sofia, 1000
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Veliko Tarnovo, 5000
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Québec, Quebec G1R 2J6
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Araucania, 4781151
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Santiago, 7500922
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Santiago, 8331143
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Valdivia, 5090000
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Victoria, 4720000
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Viña del Mar, 2540488
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Baotou, 014010
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Huaian, 223399
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Jiaxing, 314001
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Jinhua, 321000
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Lanzhou, 730000
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Linhai, 317000
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Nanning,
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Italy
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Japan
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Ampang, 68000
Malaysia
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Malaysia
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Malaysia
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Malaysia
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Malaysia
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Mexico
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Mexico
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Mexico
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Mexico
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Mexico
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Arequipa, AREQUIPA01
Peru
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Romania
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Spain
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Ukraine
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Vietnam
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Vietnam
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Vietnam
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Vietnam
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Vietnam