A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Start Date
3/31/2023
Completion Date
5/29/2036
Summary
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
Detailed Description
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. 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
Conditions
Locations
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Birmingham, Alabama 35205
United States
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Dothan, Alabama 36303
United States
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Anchorage, Alaska 99508
United States
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Chandler, Arizona 85224
United States
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Hot Springs, Arkansas 71913
United States
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Anaheim, California 92801
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Beverly Hills, California 90211
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Concord, California 94520
United States
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Corona, California 92882
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Fountain Valley, California 92708
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Greenbrae, California 94904
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Los Alamitos, California 90720
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Palo Alto, California 94304
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San Diego, California 92121
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San Diego, California 92123
United States
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Whittier, California 90603
United States
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Aurora, Colorado 80045
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Hartford, Connecticut 06102
United States
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Fort Myers, Florida 33901
United States
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Gainesville, Florida 32603
United States
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Miami Beach, Florida 33140
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Orlando, Florida 32806
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Plantation, Florida 33324
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Port Saint Lucie, Florida 34952
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Saint Augustine, Florida 32086
United States
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St. Petersburg, Florida 33705
United States
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St. Petersburg, Florida 33709
United States
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Tallahassee, Florida 32308
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West Palm Beach, Florida 33401
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Winter Haven, Florida 33880
United States
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Atlanta, Georgia 30310
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Atlanta, Georgia 30318
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Columbus, Georgia 31904
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Honolulu, Hawaii 96813
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Chicago, Illinois 60608
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Chicago, Illinois 60637
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Decatur, Illinois 62526
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Elmhurst, Illinois 60126
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Hinsdale, Illinois 60521
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Park Ridge, Illinois 60068
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Park Ridge, Illinois 60068
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Fort Wayne, Indiana 46804
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Iowa City, Iowa 52242
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Fort Mitchell, Kentucky 41017
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Lexington, Kentucky 40536
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Louisville, Kentucky 40202
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Baton Rouge, Louisiana 70809
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Brewer, Maine 04412
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Scarborough, Maine 04074
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Frederick, Maryland 21702
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Glenn Dale, Maryland 20769
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Silver Spring, Maryland 20910
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Towson, Maryland 21204
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Boston, Massachusetts 02111
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Hyannis, Massachusetts 02601
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Ann Arbor, Michigan 48109
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Detroit, Michigan 48202
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East Lansing, Michigan 48824
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Lansing, Michigan 48910
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Royal Oak, Michigan 48073
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Independence, Missouri 64057
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Lincoln, Nebraska 68506
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Las Vegas, Nevada 89148
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Laconia, New Hampshire 03246
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Belleville, New Jersey 07109
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Farmington, New Mexico 87401
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Santa Fe, New Mexico 87505
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East Syracuse, New York 13057
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New Hyde Park, New York 11042
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New York, New York 10011
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New York, New York 10019
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New York, New York 10029
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Stony Brook, New York 11794
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The Bronx, New York 10461
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White Plains, New York 10601
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Charlotte, North Carolina 28204
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Durham, North Carolina 27710-0001
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Greensboro, North Carolina 27403
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Raleigh, North Carolina 27607
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Rocky Mount, North Carolina 27804
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Winston-Salem, North Carolina 27103
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Winston-Salem, North Carolina 27104
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Cincinnati, Ohio 45219
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Cincinnati, Ohio 45255
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Cleveland, Ohio 44106
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Cleveland, Ohio 44195
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Youngstown, Ohio 44504
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Clairton, Pennsylvania 15025
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Philadelphia, Pennsylvania 19106
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Philadelphia, Pennsylvania 19111
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Pittsburgh, Pennsylvania 15213
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Reading, Pennsylvania 19611
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State College, Pennsylvania 16803
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Providence, Rhode Island 02903
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Lancaster, South Carolina 29720
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Spartanburg, South Carolina 29303
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Aberdeen, South Dakota 57401
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Mitchell, South Dakota 57301
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Pierre, South Dakota 57501
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Sioux Falls, South Dakota 57105
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Yankton, South Dakota 57078
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Chattanooga, Tennessee 37404
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Knoxville, Tennessee 37920
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Nashville, Tennessee 37203
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Nashville, Tennessee 37204
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Austin, Texas 78731
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Dallas, Texas 75230
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Denton, Texas 76201
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Houston, Texas 77024
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Houston, Texas 77030
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Irving, Texas 75063
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Ogden, Utah 84405
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Salt Lake City, Utah 84106
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Fairfax, Virginia 22031
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Lynchburg, Virginia 24501
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Midlothian, Virginia 23114
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Reston, Virginia 20190
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Richmond, Virginia 23235
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Seattle, Washington 98101
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Seattle, Washington 98104
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Spokane, Washington 99202
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Tacoma, Washington 98405
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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 53226
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Buenos Aires, C1430EGF
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CABA, C1119ACN
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Capital Federal, C1417DTB
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Ciudad Autónoma Buenos Aires, 1125
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Ciudad de Buenos Aires, 1280
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Ciudad de Buenos Aires, C1118AAT
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Ciudad de Buenos Aires, C1426ANZ
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Córdoba, 5000
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Córdoba, 5001
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La Plata, 1900
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Mar del Plata, 7600
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Salta, A4400EMI
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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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Birtinya, 4575
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Concord, 2139
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Nedlands, 6009
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Nedlands, 6009
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Randwick, 2031
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Tweed Heads, 2485
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Waratah, 2298
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Wendouree, 3355
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Graz, 8036
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Kufstein, 6330
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Ried, 4910
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Sankt Veit an der Glan, 9300
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Vienna, 1090
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Vienna, 1180
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Wein, 1130
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Wels, 4600
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Brussels, 1090
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Edegem, 2650
Belgium
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Ghent, 9000
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Leuven, 8500
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Liège, 4000
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Ottignies, 1340
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Wilrijk, 2610
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Yvoir, 5530
Belgium
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Alfenas, 37130-000
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Belo Horizonte, 30130-100
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Belo Horizonte, 30150-274
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Brasília, 70390-700
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Brasília, 71681-603
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Chapecó, 89812-220
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Cuiabá, 78040-400
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Curitiba, 80810-050
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Curitiba, 81520-060
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Fortaleza, 60170-170
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Fortaleza, 60430-230
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Lajeado, 95900000
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Londrina, 86015-520
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Natal, 59075-740
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Niterói, 24020-096
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Piracicaba, 13419-155
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Porto Alegre, 90035-001
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Porto Alegre, 90035-903
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Porto Alegre, 90050-170
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Porto Alegre, 90880-480
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Pouso Alegre, 37554-216
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Recife, 50070-070
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Ribeirão Preto, 14051-140
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Rio de Janeiro, 20560-120
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Rio de Janeiro, 22250-905
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Rio de Janeiro, 22290-160
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Salvador, 40110-060
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Salvador, 41253-190
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São Paulo, 01236-030
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São Paulo, 01317-001
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São Paulo, 01323-001
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São Paulo, 01508-010
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São Paulo, 01509-900
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São Paulo, 08270-070
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Taubaté, 12030-200
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Três Lagoas, 79601-001
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Vitória, 29055-450
Brazil
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Dobrich, 9300
Bulgaria
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Plovdiv, 4002
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Plovdiv, 4004
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Sofia, 1330
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Sofia, 1407
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Sofia, 1431
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Sofia, 1606
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Sofia, 1784
Bulgaria
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Vratsa, 3000
Bulgaria
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Calgary, Alberta T2N 4N2
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Kelowna, British Columbia V1Y 5L3
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Winnipeg, Manitoba R3E 0V9
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Barrie, Ontario L4M 6M2
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Ottawa, Ontario K1H 8L6
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Sault Ste. Marie, Ontario P6A 0A8
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Toronto, Ontario M5G 1X5
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Windsor, Ontario N8W 2X3
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Chicoutimi, Quebec G7H 5H6
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Greenfield Park, Quebec J4V 2H1
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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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Saint-Jérôme, Quebec J7Z 5T3
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Concepción, 4070196
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La Serena, 1720430
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Port Montt, 5500243
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Santiago, 8150215
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Santiago, 8330032
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Santiago, 8330336
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Talca, 3460000
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Temuco, 4780000
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Viña del Mar, 2520000
Chile
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Baoding, 071000
China
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Beijing, 100005
China
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Beijing, 100021
China
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Beijing, 100044
China
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Beijing, 100142
China
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Beijing,
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Changchun, 130021
China
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Changsha, 410008
China
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Chengdu, 610000
China
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Chengdu, 610041
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Chengdu, 610072
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Chifeng, 024000
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Dalian, 116023
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Foshan, 528000
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Fuzhou, 350001
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Fuzhou, 350011
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Guangzhou, 510060
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Guangzhou, 510120
China
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Guangzhou, 510168
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Haikou, 570102
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Haikou, 570311
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Hangzhou, 310003
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Hangzhou, 310009
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Hangzhou, 310020
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Hangzhou, 310022
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Harbin, 150081
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Hefei, 230001
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Hefei, 230012
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Hefei, 230601
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Hohhot, 010010
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Huangpu District, 200025
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Jinan, 2501117
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Lanzhou, 730050
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Liuzhou, 545005
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Nanchang, 330009
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Nanjing, 210009
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Nanjing, 210029
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Nanning, 530021
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Nanning, 530021
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Neijiang, 641000
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Qingdao, 266100
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Shanghai, 200032
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Shanghai, 200032
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Shanghai, 200127
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Shantou, 515031
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Shaoguan, 512027
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Shenyang, 110001
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Shenyang, 110016
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Shijiazhuang, 050020
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Suining, 629000
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Suzhou, 215006
China
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Taiyuan, 030000
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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, 430022
China
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Wuhan, 430070
China
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Wuhan, 430079
China
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Xiangfan, 441021
China
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Xining, 810001
China
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Xinxiang, 453100
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Xuzhou, 221000
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Xuzhou, 221009
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Yanji, 133000
China
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Yantai, 264000
China
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Zhengzhou, 450052
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Barranquilla, 080020
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Barranquilla, 80020
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Bogotá, 110221
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Bogotá, 111511
Colombia
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Cali, 760042
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Floridablanca, 681004
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Medellín, 50030
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Montería, 23001
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Pereira,
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Valledupar, 200001
Colombia
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Hořovice, 268 31
Czechia
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Pardubice, 532 03
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Prague, 140 00
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Prague, 15006
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Pragues, 18081
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Příbram, 261 01
Czechia
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Angers, 49055
France
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Argenteuil, 95100
France
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Avignon, 84918
France
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Bordeaux, 33000
France
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Bordeaux, 33077
France
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Bourg-en-Bresse, 01012
France
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Caen, 14076
France
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Cholet, 49300
France
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Clermont-Ferrand, 63011
France
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Dijon, 21079
France
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Epagny Metz-Tessy, 74370
France
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Lille, 59000
France
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Lorient, 56322
France
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Lyon, 69008
France
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Marseille, 13273
France
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Metz, 57085
France
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Montpellier, 34070
France
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Montpellier, 34298
France
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Nantes, 44202
France
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Nîmes, 30029
France
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Paris, 75010
France
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Paris, 75013
France
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Pierre-Bénite, 69310
France
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Plerin SUR MER, 22190
France
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Poitiers, 86021
France
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Quimper, 29107
France
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Rennes, 35042
France
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Saint-Cloud, 92210
France
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Saint-Herblain, 44805
France
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Saint-Priest-en-Jarez, 42270
France
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Suresnes, 92151
France
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Toulouse, 31059
France
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Tours, 37044
France
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Villejuif, 94805
France
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Batumi, 6400
Georgia
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Tbilisi, 0179
Georgia
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Tbilisi, 112
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Tbilisi, 160
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Tbilisi, 186
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Aachen, 52074
Germany
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Augsburg, 86150
Germany
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Bayreuth, 95445
Germany
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Berlin, 10317
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Berlin, 12623
Germany
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Bonn, 53111
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Deggendorf, 94469
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Dessau, 6847
Germany
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Dresden, 01307
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Düsseldorf, 40225
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Düsseldorf, 40235
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Eggenfelden, 84307
Germany
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Esslingen am Neckar, 73730
Germany
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Georgsmarienhütte, 49124
Germany
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Gütersloh, 33332
Germany
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Hamburg, 20259
Germany
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Hamburg, 21073
Germany
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Heidelberg, 69120
Germany
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Kiel, 24105
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Landshut, 84036
Germany
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Lübeck, 23562
Germany
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Mainz, 55131
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Memmingen, 87700
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München, 80637
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Rüsselsheim am Main, 65428
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Germany
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Torgau, 4860
Germany
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Trier, 54290
Germany
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Ulm, 89075
Germany
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Velbert, 42551
Germany
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Wiesbaden, 65189
Germany
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Wiesbaden, 65199
Germany
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Worms, 67550
Germany
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Germany
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Heraklion, 71110
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Ioannina, 45500
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Rio, 265 04
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Thessaloniki, 546 39
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Thessaloniki, 54631
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Thessaloniki, 54645
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Budapest, 1106
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Hungary
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Bangalore, 560076
India
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India
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Hyderabad, 500082
India
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India
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India
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India
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India
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New Delhi, 110 085
India
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New Delhi, 110005
India
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New Delhi, 110076
India
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Pune, 411004
India
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Thane, 401107
India
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West Bengal, 700 156
India
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Afula, 1834111
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Ashdod, 7747629
Israel
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Israel
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Israel
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Israel
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Israel
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Israel
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Israel
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Italy
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Italy
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Italy
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Italy
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Italy
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Italy
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Milan, 20141
Italy
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Italy
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Naples, 80131
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Naples, 80131
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Pisa, 56126
Italy
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Reggio Emilia, 42122
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Roma, 00168
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Rozzano, 20089
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Turin, 10128
Italy
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Chiba, 260-8717
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Chūōku, 104-8560
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Fukuoka, 811-1395
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Fukushima, 960-1295
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