An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Start Date
10/5/2023
Completion Date
5/6/2037
Summary
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
Detailed Description
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.
Eligibility Criteria
Age Range: 18 years to 130 years
Interventions
Camizestrant
Tamoxifen
Anastrozole
Letrozole
Exemestane
Abemaciclib
Conditions
Locations
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Dothan, Alabama 36303
United States
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Phoenix, Arizona 85054
United States
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Tucson, Arizona 85745
United States
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Fayetteville, Arkansas 72703
United States
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Duarte, California 91010
United States
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Fountain Valley, California 92708
United States
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Greenbrae, California 94904
United States
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Irvine, California 92618
United States
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La Jolla, California 92093
United States
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Los Angeles, California 90017
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Monterey, California 93940
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Walnut Creek, California 94598
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West Hollywood, California 90048
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Aurora, Colorado 80045
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Littleton, Colorado 80120
United States
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Littleton, Colorado 80129
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New Haven, Connecticut 06510
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Newark, Delaware 19713
United States
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Washington D.C., District of Columbia 20016
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Clearwater, Florida 33756
United States
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Fort Myers, Florida 33901
United States
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Gainesville, Florida 32610
United States
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Jacksonville, Florida 32224
United States
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Orlando, Florida 32806
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Pembroke Pines, Florida 33028
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Plantation, Florida 33322
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Plantation, Florida 33324
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St. Petersburg, Florida 33705
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St. Petersburg, Florida 33709
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Tallahassee, Florida 32308
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West Palm Beach, Florida 33401
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Atlanta, Georgia 30318
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Atlanta, Georgia 30322
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Columbus, Georgia 31904
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Marietta, Georgia 30060
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Savannah, Georgia 31404
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Thomasville, Georgia 31792
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Chicago, Illinois 60637
United States
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Elmhurst, Illinois 60126
United States
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Naperville, Illinois 60540
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Park Ridge, Illinois 60068
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Plainfield, Illinois 60585
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Urbana, Illinois 61801
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Fort Wayne, Indiana 46804
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Des Moines, Iowa 50309
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Fairway, Kansas 66205
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Louisville, Kentucky 40202
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New Orleans, Louisiana 70121
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Scarborough, Maine 04074
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Annapolis, Maryland 21401
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Baltimore, Maryland 21201
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Baltimore, Maryland 21287
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Bethesda, Maryland 20817
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Lutherville, Maryland 21093
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Towson, Maryland 21204
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Boston, Massachusetts 02111
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Boston, Massachusetts 02115
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Hyannis, Massachusetts 02601
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Worcester, Massachusetts 01655
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Detroit, Michigan 48202
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Flint, Michigan 48503
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Ypsilanti, Michigan 48197
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Minneapolis, Minnesota 55416
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Rochester, Minnesota 55905
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Kansas City, Missouri 64111
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St Louis, Missouri 63110
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St Louis, Missouri 63131
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Lincoln, Nebraska 68506
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Omaha, Nebraska 68124
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Omaha, Nebraska 68198
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Hooksett, New Hampshire 03106
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Lebanon, New Hampshire 03756
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Manchester, New Hampshire 03103
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New Brunswick, New Jersey 08901
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Albuquerque, New Mexico 87109
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Farmington, New Mexico 87401
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Bay Shore, New York 11706
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East Syracuse, New York 13057
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Greenlawn, New York 11740
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New Hyde Park, New York 11042
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New York, New York 10029
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New York, New York 10065
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New York, New York 10065
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Stony Brook, New York 11794
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White Plains, New York 10601
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Charlotte, North Carolina 28204
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Durham, North Carolina 27710
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Greensboro, North Carolina 27403
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Greenville, North Carolina 27834
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Pinehurst, North Carolina 28374
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Raleigh, North Carolina 27607
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Winston-Salem, North Carolina 27103
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Blue Ash, Ohio 45242
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Cincinnati, Ohio 45255
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Cleveland, Ohio 44106
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Columbus, Ohio 43212
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Toledo, Ohio 43623
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Youngstown, Ohio 44504
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Oklahoma City, Oklahoma 73104
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Portland, Oregon 97210
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Portland, Oregon 97213
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Portland, Oregon 97225
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Gettysburg, Pennsylvania 17325
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Hershey, Pennsylvania 17033
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15213
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Sayre, Pennsylvania 18840
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York, Pennsylvania 17403
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Charleston, South Carolina 29425
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Greenville, South Carolina 29605
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Rock Hill, South Carolina 29732
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Spartanburg, South Carolina 29303
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Aberdeen, South Dakota 57401
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Sioux Falls, South Dakota 57105
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Chattanooga, Tennessee 37404
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Knoxville, Tennessee 37909
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Knoxville, Tennessee 37920
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Memphis, Tennessee 38120
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Nashville, Tennessee 37203
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Nashville, Tennessee 37232
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Austin, Texas 78731
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Bedford, Texas 76022
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Dallas, Texas 75230
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Dallas, Texas 75231
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Dallas, Texas 75246
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El Paso, Texas 79902
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Flower Mound, Texas 75028
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Houston, Texas 77024
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Houston, Texas 77030
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Plano, Texas 75075
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San Antonio, Texas 78217
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Tyler, Texas 75702
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Salt Lake City, Utah 84112
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Charlottesville, Virginia 22908
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Fairfax, Virginia 22031
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Midlothian, Virginia 23114
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Norfolk, Virginia 23502
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Richmond, Virginia 23219
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Roanoke, Virginia 24014
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Winchester, Virginia 22601
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Puyallup, Washington 98373
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Spokane, Washington 99202
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Vancouver, Washington 98684
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Charleston, West Virginia 25304
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Morgantown, West Virginia 26505
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Appleton, Wisconsin 54911
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Madison, Wisconsin 53792
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Milwaukee, Wisconsin 53215
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Buenos Aires, C1417
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CABA, C1061
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Capital Federal, 1118
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Ciudad de Buenos Aires, 1426
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Ciudad de Buenos Aires, C1025ABI
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Ciudad de Buenos Aires, C1426ANZ
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Córdoba, 5001
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Córdoba, X5800HHW
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La Plata, 1900
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Rosario, 2123
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San Juan, 5400
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San Miguel de Tucumán, 4000
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San Miguel de Tucumán, T4000IAK
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Viedma, R8500ACE
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Adelaide, 5081
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Bankstown, 2200
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Bendigo, 3550
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Bowral, 2576
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Brighton, 3186
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Clayton, 3168
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Coffs Harbour, 2450
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Fitzroy, 3065
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Frankston, 3199
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Garran, 2605
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Gateshead, 2290
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Heidelberg, 3084
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Liverpool, 2170
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Melbourne, 3004
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Murdoch, WA6150
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Randwick, 2031
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Richmond, 3121
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Shepparton, 3630
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South Brisbane, 4101
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St Leonards, 2065
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Subiaco, 6008
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Traralgon, 3844
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Wangaratta, 3677
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Waratah, 2298
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Warnnambool, 3280
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Wollongong, 2500
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Graz, 8036
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Innsbruck, 6020
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Klagenfurt, 9020
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Linz, 4010
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Linz, 4021
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Salzburg, 5020
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Sankt Veit an der Glan, 9300
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Steyr, 4400
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Vienna, 1090
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Vienna, 1130
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Vienna, 1160
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Vienna, 1180
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Wels, 4600
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Wiener Neustadt, 2700
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Aalst, 9300
Belgium
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Anderlecht, 1070
Belgium
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Brasschaat, 2930
Belgium
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Brussels, 1200
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Charleroi, 6000
Belgium
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Edegem, 2650
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Ghent, 9000
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Leuven, 3000
Belgium
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Namur, 5000
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Wilrijk, 2610
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Alfenas, 37130-000
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Belo Horizonte, 30130-100
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Blumenau, 89010-340
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Brasília, 71615-907
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Curitiba, 80730-380
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Curitiba, 80810-050
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Fortaleza, 60135-237
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Fortaleza, 60430-230
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Goiânia, 74000-000
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Itajaí, 88301-220
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João Pessoa, 58013-140
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Natal, 59075-740
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Porto Alegre, 90035-001
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Porto Alegre, 90050-170
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Porto Alegre, 90610000
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Porto Velho, 76834-899
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Pouso Alegre, 37554-216
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Recife, 50070-480
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Ribeirão Preto, 14015-130
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Rio de Janeiro, 20560-120
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Rio de Janeiro, 22793-080
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Salvador, 40170-110
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Santo André, 09060-650
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São Paulo, 01246-000
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São Paulo, 01327-001
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São Paulo, 01409-902
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São Paulo, 03102-006
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Taubaté, 12030-200
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Teresina, 64049-200
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Três Lagoas, 79601-001
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Vitória, 29043-260
Brazil
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Dobrich, 9300
Bulgaria
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Haskovo, 6300
Bulgaria
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Plovdiv, 4002
Bulgaria
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Plovdiv, 4004
Bulgaria
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Shumen, 9700
Bulgaria
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Sofia, 1330
Bulgaria
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Sofia, 1404
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Sofia, 1407
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Sofia, 1431
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Varna, 9010
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Vratsa, 3000
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Calgary, Alberta T2N 4N2
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Edmonton, Alberta t6G1Z2
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Kelowna, British Columbia V1Y 5L3
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North Vancouver, British Columbia V7L 2L7
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Halifax, Nova Scotia B3H 2Y9
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Barrie, Ontario L4M 6M2
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Greater Sudbury, Ontario P3E 5J1
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Kingston, Ontario K7L 2V7
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Sault Ste. Marie, Ontario P6A 0A8
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Thunder Bay, Ontario P7B 6V4
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Windsor, Ontario N8W 2X3
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Chicoutimi, Quebec G7H 5H6
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Lévis, Quebec G6V 3Z1
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Montreal, Quebec H1T 2M4
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Montreal, Quebec H2X 3E4
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Montreal, Quebec H4A 3J1
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Québec, Quebec G1S 4L8
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Saskatoon, Saskatchewan S7N 4H4
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Concepción, 4070196
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La Serena, 1720430
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Port Montt, 5500243
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Providencia, 7510032
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Santiago, 7620157
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Santiago, 8150215
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Santiago, 8330032
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Santiago, 8330336
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Temuco, 4810218
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Viña del Mar, 2520000
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Baoding, 071000
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Beijing, 100021
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Beijing, 100039
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Beijing, 100142
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Beijing, 100191
China
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Beijing, 100730
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Bengbu, 233004
China
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Binzhou, 256606
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Cangzhou, 061001
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Changchun, 130021
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Changsha, 410008
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Chengdu, 610042
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Chengdu, 610072
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Chifeng, 024000
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Dalian, 116011
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Foshan, 528000
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Fuzhou, 350014
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Guangzhou, 510060
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Guangzhou, 510080
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Guangzhou, 510168
China
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Haikou, 570311
China
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Haikou, 570311
China
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Hangzhou, 310000
China
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Hangzhou, 310009
China
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Hangzhou, 310016
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Hangzhou, 310022
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Harbin, 150081
China
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Hefei, 230001
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Hefei, 230012
China
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Hefei, 230022
China
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Hefei, 230601
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Hohhot, 010017
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Huizhou, 516001
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Jinzhou, 121001
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Lanzhou, 730050
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Linyi, 276000
China
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Liuzhou, 545005
China
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Liuzhou, 545006
China
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Nanchang, 330009
China
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Nanjing, 210009
China
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Nanjing, 210029
China
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Nanning, 530021
China
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Nantong, 226001
China
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Neijiang, 641000
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Shandong, 250117
China
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Shangqiu, 476100
China
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Shantou, 515031
China
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Shaoguan Shi, 512025
China
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Shenyang, 110001
China
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Shenyang, 110042
China
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Shenzhen, 518020
China
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Shenzhen, 518116
China
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Shijiazhuang, 050011
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Suining Shi, 629000
China
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Suzhou, 215004
China
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Suzhou, 215006
China
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Suzhou, 215600
China
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Taizhou, 317000
China
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Tianjin, 300060
China
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Weifang, 261000
China
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Wuhan, 430030
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Wuhan, 430060
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Wuhan, 430079
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Xi'an, 710004
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Xiangfan, 441021
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Xinxiang, 453100
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Xuzhou, 221002
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Xuzhou, 221009
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Zunyi, 563100
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Bogotá, 110221
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Cali, 760042
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Medellín, 050030
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Montería, 23001
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Valledupar, 200001
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Osijek, 31000
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Rijeka, 51000
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Split, 21000
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Zadar, 23000
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Zagreb, 10000
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Brno, 625 00
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Hořovice, 26831
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Liberec, 46063
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Pardubice, 532 03
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Prague, 150 06
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Tallinn, 10138
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Tallinn, 11619
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Tartu, 50406
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Angers, 49100
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Bordeaux, 33076
France
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Caen, 14076
France
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Clermont-Ferrand, 63000
France
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Dijon, 21000
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Epagny Metz-Tessy, 74370
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Lille, 59000
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Lyon, 75004
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Paris, 75005
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Rennes, 35000
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Rouen, 76021
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Saint-Cloud, 92210
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Saint-Herblain, 44800
France
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Saint-Priest-en-Jarez, 42270
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Strasbourg, 67200
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France
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Tbilisi, 0102
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Tbilisi, 114
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Hanover, 30177
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Heidelberg, 69120
Germany
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Mainz, 55131
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Germany
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Athens, 12462
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Rio, 265 04
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Thessaloniki, 546 39
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Thessaloniki, 54645
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Thessaloniki, 552 36
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Thessaloniki, 56403
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Thessaloniki, 570 01
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Budapest, 1082
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Budapest, 1122
Hungary
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Debrecen, 4032
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Győr, 9024
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Gyula, 5700
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Kaposvár, 7400
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Kecskemét, 6000
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Miskolc, 3526
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Nyíregyháza, 4400
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Salgótarján, 3100
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Hungary
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Hungary
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Hungary
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Bangalore, 560064
India
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Belgavi, 590010
India
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Dehradun, 248016
India
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Delhi, 110088
India
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