Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
Start Date
3/14/2025
Completion Date
12/17/2029
Summary
Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1. Upon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation. Site visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD. In case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.
Eligibility Criteria
Age Range: 40 years to No maximum
Interventions
Baxdrostat and dapagliflozin
Placebo and dapagliflozin
Conditions
Locations
Research Site
Birmingham, Alabama 35205
United States
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Centreville, Alabama 35042
United States
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Fairhope, Alabama 36532
United States
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Huntsville, Alabama 35801
United States
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Mobile, Alabama 36608
United States
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Sheffield, Alabama 35660
United States
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Vestavia Hills, Alabama 35216
United States
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Anchorage, Alaska 99508
United States
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Gilbert, Arizona 85296
United States
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Glendale, Arizona 85308
United States
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Tempe, Arizona 85283
United States
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Tucson, Arizona 85712
United States
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Dublin, California 94568
United States
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Huntington Beach, California 92648
United States
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Inglewood, California 90301
United States
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La Jolla, California 92037
United States
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Lakewood, California 90805
United States
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Lincoln, California 95648
United States
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Loma Linda, California 92357
United States
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Los Angeles, California 90035
United States
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Los Angeles, California 90073
United States
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Sacramento, California 95841
United States
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San Diego, California 92120
United States
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San Dimas, California 91773
United States
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San Francisco, California 94115
United States
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San Francisco, California 94121
United States
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Santa Maria, California 93454
United States
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Sherman Oaks, California 91403
United States
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Thousand Oaks, California 91360
United States
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Aurora, Colorado 80012
United States
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Englewood, Colorado 80110
United States
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Bridgeport, Connecticut 06606
United States
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Stamford, Connecticut 06905
United States
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Waterbury, Connecticut 06708
United States
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Crystal River, Florida 34429
United States
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Fort Lauderdale, Florida 33316
United States
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Fort Myers, Florida 33912
United States
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Gainesville, Florida 32608
United States
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Jacksonville, Florida 32216
United States
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Lakeland, Florida 33813
United States
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Miami, Florida 33125
United States
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Miami, Florida 33135
United States
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Miami, Florida 33173
United States
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Miami, Florida 33175
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Miami Lakes, Florida 33016
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Ocoee, Florida 34761
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Orlando, Florida 32822
United States
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Palmetto Bay, Florida 33157
United States
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Saint Augustine, Florida 32086
United States
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Albany, Georgia 31707
United States
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Atlanta, Georgia 30303
United States
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Canton, Georgia 30114
United States
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Columbus, Georgia 31904
United States
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Cordele, Georgia 31015
United States
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Suwanee, Georgia 30024
United States
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Tucker, Georgia 30084
United States
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Woodstock, Georgia 30189
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Idaho Falls, Idaho 83404
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Champaign, Illinois 61822
United States
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Chicago, Illinois 60616
United States
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Chicago, Illinois 60621
United States
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Chicago, Illinois 60631
United States
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Gurnee, Illinois 60031
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Island Lake, Illinois 60042
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Park Ridge, Illinois 60068
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Indianapolis, Indiana 46202
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Munster, Indiana 46321
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Richmond, Indiana 47374
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South Bend, Indiana 46617
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El Dorado, Kansas 67042
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Lenexa, Kansas 66219
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Newton, Kansas 67114
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Wichita, Kansas 67218
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Lexington, Kentucky 40509
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Louisville, Kentucky 40218
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Owensboro, Kentucky 42301
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Paducah, Kentucky 42001
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Alexandria, Louisiana 71303
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Bossier City, Louisiana 71111
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Shreveport, Louisiana 71101
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Baltimore, Maryland 21229
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Beltsville, Maryland 20705
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Lutherville-Timonium, Maryland 21093
United States
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Potomac, Maryland 20854
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Boston, Massachusetts 02115
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New Bedford, Massachusetts 02740
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Roslindale, Massachusetts 02131
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Farmington Hills, Michigan 48336
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Flint, Michigan 48532
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Troy, Michigan 48098
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Ypsilanti, Michigan 48197
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Mankato, Minnesota 56001
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Minneapolis, Minnesota 55417
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Columbia, Missouri 65201
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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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Kalispell, Montana 59901
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Missoula, Montana 59804
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Norfolk, Nebraska 68701
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Omaha, Nebraska 68134
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Carson City, Nevada 89706
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Portsmouth, New Hampshire 03801
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Eatontown, New Jersey 07724
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Pennington, New Jersey 08534
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Somerset, New Jersey 08873
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Albuquerque, New Mexico 87102
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Albuquerque, New Mexico 87108
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Albany, New York 12208
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Albany, New York 12211
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Brooklyn, New York 11201
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Brooklyn, New York 11220
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Massapequa, New York 11758
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New York, New York 10029
United States
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Queens Village, New York 11428
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Charlotte, North Carolina 28287
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Durham, North Carolina 27701
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Fayetteville, North Carolina 28304
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Kernersville, North Carolina 27284
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Kinston, North Carolina 28504
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Monroe, North Carolina 28112
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New Bern, North Carolina 28562
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New Bern, North Carolina 28562
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Raleigh, North Carolina 27607
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Rocky Mount, North Carolina 27804
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Wilmington, North Carolina 28401
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Fargo, North Dakota 58104
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Beavercreek, Ohio 45431
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Canton, Ohio 44718
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45220
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Columbus, Ohio 43215
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Columbus, Ohio 43228
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Dayton, Ohio 45424
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Maumee, Ohio 43537
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Toledo, Ohio 43606
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Norman, Oklahoma 73069
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Oklahoma City, Oklahoma 73111
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Oklahoma City, Oklahoma 73120
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Medford, Oregon 97504
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Camp Hill, Pennsylvania 17011
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Horsham, Pennsylvania 19044
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Philadelphia, Pennsylvania 19114
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Scottdale, Pennsylvania 15683
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Smithfield, Pennsylvania 15478
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West Chester, Pennsylvania 19380
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Columbia, South Carolina 29209
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Fort Mill, South Carolina 29715
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Greenville, South Carolina 29615
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Mt. Pleasant, South Carolina 29464
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North Charleston, South Carolina 29405
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Spartanburg, South Carolina 29301
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Cleveland, Tennessee 37312
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Morristown, Tennessee 37813
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Nashville, Tennessee 37203
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Abilene, Texas 79606
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Austin, Texas 78704
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Beaumont, Texas 77702
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Brownsville, Texas 78526
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Dallas, Texas 75390-9015
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Duncanville, Texas 75137
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El Paso, Texas 79905
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El Paso, Texas 79935
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Houston, Texas 77084
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Houston, Texas 77089
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Lewisville, Texas 75067
United States
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Mansfield, Texas 76063
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McAllen, Texas 78501
United States
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McAllen, Texas 78503
United States
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Mesquite, Texas 75149
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Paris, Texas 75462
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Pearland, Texas 77584
United States
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San Antonio, Texas 78231
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San Antonio, Texas 78257
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Stephenville, Texas 76401
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Sugar Land, Texas 77479
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Tomball, Texas 77375
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Weslaco, Texas 78596
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Woodway, Texas 76712
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Clearfield, Utah 84015
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Ogden, Utah 84405
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Burlington, Vermont 05401
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Burke, Virginia 22015
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Charlottesville, Virginia 22911
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Fairfax, Virginia 22033
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Falls Church, Virginia 22042
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Manassas, Virginia 20110
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Midlothian, Virginia 23112
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Norfolk, Virginia 23502
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Norfolk, Virginia 23504
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Richmond, Virginia 23249
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Salem, Virginia 24153
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Puyallup, Washington 98372
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Redmond, Washington 98052
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Renton, Washington 98057
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Kingwood, West Virginia 26537
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Morgantown, West Virginia 26505
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Green Bay, Wisconsin 54303
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Milwaukee, Wisconsin 53226
United States
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Buenos Aires, C1425AGC
Argentina
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CABA, C1056ABH
Argentina
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CABA, C1119ACN
Argentina
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CABA, C1120AAC
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Caba, C1128AAF
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Ciudad de Buenos Aires, C1428DCO
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Córdoba, 5000
Argentina
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Córdoba, X5003DCP
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La Plata, B1904
Argentina
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Mar del Plata, B7600FZN
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Mar del Plata, B7600GNY
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Rosario, 2000
Argentina
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Rosario, S2000PBJ
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San Nicolás, B2900DMH
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San Nicolás de los Arroyos, B2900DPA
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San Vicente, 5006
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Santa Fe, S3000FWO
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Adelaide, 5000
Australia
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Castle Hill, 2154
Australia
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Coffs Harbour, 02450
Australia
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Elizabeth Vale, 5112
Australia
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Fremantle, 6160
Australia
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Geelong, 3220
Australia
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Kingswood, 2747
Australia
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Leabrook, 5068
Australia
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Maroubra, 2035
Australia
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Merewether, 2291
Australia
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Milton, 4064
Australia
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Mulgrave, 3170
Australia
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Osborne Park, 6017
Australia
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Rockhampton, 4700
Australia
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Wollongong, 2500
Australia
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Belém, 66073-005
Brazil
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Blumenau, 89010-022
Brazil
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Bragança Paulista, 12916-542
Brazil
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Brasília, 71625-009
Brazil
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Campina Grande do Sul, 83.430-000
Brazil
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Campinas, 13060-080
Brazil
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Campinas, 13060-904
Brazil
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Curitiba, 80030-480
Brazil
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Curitiba, 80810-050
Brazil
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Juiz de Fora, 36033-318
Brazil
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Natal, 59020-035
Brazil
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Porto Alegre, 90160-093
Brazil
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Porto Alegre, 9061-000
Brazil
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Porto Alegre, 90630-165
Brazil
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Porto Alegre, 91350-200
Brazil
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Rio de Janeiro, 20241-180
Brazil
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São José do Rio Preto, 15090-000
Brazil
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São José dos Campos, 12230-001
Brazil
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São Paulo, 01228-000
Brazil
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São Paulo, 01236-030
Brazil
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São Paulo, 04012-180
Brazil
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São Paulo, 05403-000
Brazil
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Tatuí, 18270-170
Brazil
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Haskovo, 6300
Bulgaria
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Panagyurishte, 4500
Bulgaria
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Petrich, 2850
Bulgaria
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Pleven, 5800
Bulgaria
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Pleven, 5804
Bulgaria
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Plovdiv, 4003
Bulgaria
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Rousse, 7000
Bulgaria
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Shumen, 9700
Bulgaria
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Sofia, 1000
Bulgaria
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Sofia, 1309
Bulgaria
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Sofia, 1404
Bulgaria
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Sofia, 1431
Bulgaria
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Sofia, 1527
Bulgaria
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Sofia, 1618
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Sofia, 1680
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Stara Zagora, 6003
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Varna, 9000
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Calgary, Alberta T2H 2G4
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Calgary, Alberta T2V 4J2
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Sherwood Park, Alberta T8H 0N2
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Abbotsford British Columbia, British Columbia V2S 0C2
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Moncton, New Brunswick E1C 2Z3
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Saint John, New Brunswick E2L 4L2
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St. John's, Newfoundland and Labrador A1B 3V6
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Halifax, Nova Scotia B3H 1V7
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Sydney, Nova Scotia B1P 1P3
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Cambridge, Ontario N1R 6V6
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Guelph, Ontario N1H 1B1
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Hamilton, Ontario L8J 0B6
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Hamilton, Ontario L8L 5G4
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Markham, Ontario L3S 0A2
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Newmarket, Ontario L3Y 2P6
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North York, Ontario M6B 3H7
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North York, Ontario M9N 1W4
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Oakville, Ontario L6K 3W7
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Ottawa, Ontario K2J 0V2
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Sarnia, Ontario N7T 4X3
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Scarborough Village, Ontario M1B 4Z8
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Toronto, Ontario M4G 3E8
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Toronto, Ontario M5B 1W8
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Toronto, Ontario M6G 1M2
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Toronto, Ontario M6G 3S5
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Laval, Quebec H7T 2P5
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Lévis, Quebec G6V 9H4
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Mirabel, Quebec J7J 2K8
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Montreal, Quebec H1T 1C8
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Montreal, Quebec H4A 3T2
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Québec, Quebec G1G 5X1
Canada
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Québec, Quebec G1V 4G5
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Saint-Charles-Borromée, Quebec J6E 6J2
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Sherbrooke, Quebec J1H 5N4
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Terrebonne, Quebec J6X 4P7
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Trois-Rivières, Quebec G9A 4P3
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Regina, Saskatchewan S4P 0W5
Canada
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Baotou, 14010
China
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Beijing, 100029
China
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Beijing, 100029
China
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Beijing, 100050
China
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Changchun, 130021
China
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Changchun, 130033
China
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Changde, 415000
China
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Changsha, 410011
China
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Changsha, 410015
China
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Changzhou, 272100
China
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Chengdu, 610000
China
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Chengdu, 610041
China
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Chifeng, 024000
China
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Chongqing, 400014
China
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Chongqing, 400042
China
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Guangzhou, 510100
China
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Guangzhou, 511486
China
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Harbin, 150000
China
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Hefei, 230001
China
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Hengyang, 421001
China
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Heze, 274099
China
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Huangshi, 435000
China
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Huizhou, 516002
China
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Jinan, 250001
China
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Jining, 272006
China
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Kaifeng, 475000
China
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Liaocheng, 252000
China
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Linyi, 276003
China
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Lishui, 323000
China
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Luoyang, 471000
China
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Luoyang, 471001
China
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Meihekou, 135022
China
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Nanchang, 330009
China
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Nanjing, 210008
China
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Nantong, 226001
China
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Nanyang, 473000
China
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Panjin, 124009
China
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Pingxiang, 337055
China
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Sanya, 572000
China
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Shanghai, 200240
China
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Shanghai, 201114
China
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Shenyang, 110016
China
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Siping, 136000
China
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Suzhou, 215004
China
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Taiyuan, 030024
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Taizhou, 317000
China
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Tianjin, 300000
China
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Wenzhou, 325000
China
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Wuhan, 430010
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Wuhan, 430060
China
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Xi'an, 710061
China
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Xi'an, 710068
China
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Xianyang, 750004
China
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Xuzhou, 221009
China
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Yinchuan, 750004
China
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Zhumadian, 463000
China
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Zigong, 643000
China
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Benešov, 256 01
Czechia
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Brandýs nad Labem, 250 01
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Brno, 603 00
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Brno, 639 00
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Broumov, 55001
Czechia
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Chlumec nad Cidlinou, 503 51
Czechia
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Hodonín, 695 01
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Humpolec, 396 01
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Jílové u Prahy, 254 01
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Krnov, 794 01
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Olomouc, 772 00
Czechia
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Ostrava, 702 00
Czechia
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Pilsen, 301 00
Czechia
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Police nad Metují, 549 54
Czechia
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Prague, 101 00
Czechia
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Prague, 104 00
Czechia
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Prague, 12808
Czechia
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Prague, 149 00
Czechia
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Prague, 150 00
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Prague, 190 14
Czechia
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Aarhus, 8200
Denmark
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Aarhus N, 8200
Denmark
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Copenhagen, 2300
Denmark
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Esbjerg, 6700
Denmark
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Frederiksberg, 2000
Denmark
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Gistrup, 9260
Denmark
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Herlev, 2730
Denmark
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Herning, 7400
Denmark
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Hillerød, 3400
Denmark
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Hjørring, 9800
Denmark
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Holbæk, 4300
Denmark
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Hvidovre, 2650
Denmark
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Roskilde, 4000
Denmark
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Slagelse, DK-4200
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Svendborg, 5700
Denmark
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Viborg, 8800
Denmark
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Amiens, 80054
France
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Angers, 49933
France
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Aurillac, 15002
France
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Besançon, 25030
France
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Bobigny, 93000
France
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Bois-Guillaume, 76230
France
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Brest, 29200
France
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Caen, 14033
France
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Cholet, 49300
France
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Clermont-Ferrand, 63000
France
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Colombes, 92700
France
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Corbeil-Essonnes, 91106
France
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Dijon, 2100
France
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La Roche-sur-Yon, 85925
France
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La Rochelle, 17000
France
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Le Coudray, 28630
France
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Le Creusot, 71206
France
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Lyon, 69007
France
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Marseille, 13385
France
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Montpellier, 34295
France
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Nantes, 44093
France
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Narbonne, 11108
France
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Nîmes, 30029
France
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Paris, 75010
France
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Paris, 75014
France
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Paris, 75018
France
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Paris, 75908
France
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Pierre-Bénite, 69495
France
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Toulouse, 31059
France
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Vandœuvre-lès-Nancy, 54511
France
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Villeurbanne, 69100
France
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Aachen, 52074
Germany
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Amberg, 92224
Germany
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Bad Homburg, 61348
Germany
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Bad Oeynhausen, 32545
Germany
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Bamberg, 96049
Germany
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Bechhofen, 66894
Germany
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Berlin, 10367
Germany
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Berlin, 10789
Germany
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Berlin, 12203
Germany
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Berlin, 13187
Germany
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Berlin, 13353
Germany
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Berlin, 13597
Germany
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Bochum, 44789
Germany
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Bochum, 44869
Germany
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Brandenburg an der Havel, 14770
Germany
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Brandenburg an der Havel, 14776
Germany
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Bremen, 28277
Germany
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Cologne, 51065
Germany
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Cologne, 51069
Germany
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Deggingen, 73326
Germany
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Dresden, 01069
Germany
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Dresden, 01277
Germany
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Elsterwerda, 04910
Germany
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Essen, 45136
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Southampton, SO303JB
United Kingdom
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Stockton-on-Tees, TS19 8PE
United Kingdom
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Swansea, SA6 6NL
United Kingdom
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Weston-super-Mare, BS24 7PR
United Kingdom
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Wolverhampton, WV10 0QP
United Kingdom
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Woodbridge, IP136TH
United Kingdom
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Yate, BS37 4AX
United Kingdom
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Can Tho, 900000
Vietnam
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Haiphong, 180000
Vietnam
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Hanoi, 10000
Vietnam
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Hà Nội, 100000
Vietnam
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Ho Chi Minh City, 700000
Vietnam
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Ho Chi Minh City, 700000
Vietnam
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Ho Chi Minh City, 70000
Vietnam
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Hochiminh City, 700000
Vietnam
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Huế, 530000
Vietnam
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Rach Gia, 920000
Vietnam
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Vĩnh Yên, 280000
Vietnam