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NCT05952557PHASE3Recruiting

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

AstraZeneca

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

Inclusion Criteria: * Women and Men; ≥18 years at the time of screening (or per national guidelines) * Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol. * Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy. * Patients must be randomised within 12 months of definitive breast surgery. * Patients may have received up to 12 weeks of endocrine therapy prior to randomisation. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Adequate organ and bone marrow function Exclusion Criteria: * Inoperable locally advanced or metastatic breast cancer * Pathological complete response following treatment with neoadjuvant therapy * History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation * Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance " * Known LVEF \<50% with heart failure NYHA Grade ≥2. * Mean resting QTcF interval \> 480 ms at screening * Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions * Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab) * Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant * Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding. * Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.

Interventions

DRUG

Camizestrant

DRUG

Tamoxifen

DRUG

Anastrozole

DRUG

Letrozole

DRUG

Exemestane

DRUG

Abemaciclib

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Conditions

Breast Cancer, Early Breast Cancer

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

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Duarte, California 91010

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Fountain Valley, California 92708

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Greenbrae, California 94904

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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

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Littleton, Colorado 80129

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New Haven, Connecticut 06510

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Newark, Delaware 19713

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Washington D.C., District of Columbia 20016

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Clearwater, Florida 33756

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Fort Myers, Florida 33901

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Gainesville, Florida 32610

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Jacksonville, Florida 32224

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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

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Elmhurst, Illinois 60126

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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

United States

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Buenos Aires, C1417

Argentina

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CABA, C1061

Argentina

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Capital Federal, 1118

Argentina

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Ciudad de Buenos Aires, 1426

Argentina

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Ciudad de Buenos Aires, C1025ABI

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Ciudad de Buenos Aires, C1426ANZ

Argentina

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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

Argentina

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San Miguel de Tucumán, T4000IAK

Argentina

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Viedma, R8500ACE

Argentina

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Adelaide, 5081

Australia

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Bankstown, 2200

Australia

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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

Australia

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Melbourne, 3004

Australia

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Murdoch, WA6150

Australia

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Randwick, 2031

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Richmond, 3121

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Shepparton, 3630

Australia

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South Brisbane, 4101

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St Leonards, 2065

Australia

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Subiaco, 6008

Australia

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Traralgon, 3844

Australia

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Wangaratta, 3677

Australia

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Waratah, 2298

Australia

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Warnnambool, 3280

Australia

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Wollongong, 2500

Australia

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Graz, 8036

Austria

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Innsbruck, 6020

Austria

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Klagenfurt, 9020

Austria

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Linz, 4010

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Linz, 4021

Austria

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Salzburg, 5020

Austria

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Sankt Veit an der Glan, 9300

Austria

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Steyr, 4400

Austria

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Vienna, 1090

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Vienna, 1130

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Vienna, 1160

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Vienna, 1180

Austria

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Wels, 4600

Austria

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Wiener Neustadt, 2700

Austria

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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

Belgium

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Charleroi, 6000

Belgium

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Edegem, 2650

Belgium

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Ghent, 9000

Belgium

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Leuven, 3000

Belgium

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Namur, 5000

Belgium

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Wilrijk, 2610

Belgium

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Alfenas, 37130-000

Brazil

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Belo Horizonte, 30130-100

Brazil

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Blumenau, 89010-340

Brazil

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Brasília, 71615-907

Brazil

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Curitiba, 80730-380

Brazil

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Curitiba, 80810-050

Brazil

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Fortaleza, 60135-237

Brazil

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Fortaleza, 60430-230

Brazil

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Goiânia, 74000-000

Brazil

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Itajaí, 88301-220

Brazil

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João Pessoa, 58013-140

Brazil

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Natal, 59075-740

Brazil

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Porto Alegre, 90035-001

Brazil

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Porto Alegre, 90050-170

Brazil

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Porto Alegre, 90610000

Brazil

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Porto Velho, 76834-899

Brazil

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Pouso Alegre, 37554-216

Brazil

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Recife, 50070-480

Brazil

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Ribeirão Preto, 14015-130

Brazil

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Rio de Janeiro, 20560-120

Brazil

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Rio de Janeiro, 22793-080

Brazil

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Salvador, 40170-110

Brazil

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Santo André, 09060-650

Brazil

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São Paulo, 01246-000

Brazil

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São Paulo, 01327-001

Brazil

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São Paulo, 01409-902

Brazil

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São Paulo, 03102-006

Brazil

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Taubaté, 12030-200

Brazil

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Teresina, 64049-200

Brazil

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Três Lagoas, 79601-001

Brazil

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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

Bulgaria

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Sofia, 1407

Bulgaria

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Sofia, 1431

Bulgaria

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Varna, 9010

Bulgaria

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Vratsa, 3000

Bulgaria

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Calgary, Alberta T2N 4N2

Canada

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Edmonton, Alberta t6G1Z2

Canada

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Kelowna, British Columbia V1Y 5L3

Canada

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North Vancouver, British Columbia V7L 2L7

Canada

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Halifax, Nova Scotia B3H 2Y9

Canada

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Barrie, Ontario L4M 6M2

Canada

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Greater Sudbury, Ontario P3E 5J1

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Kingston, Ontario K7L 2V7

Canada

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Sault Ste. Marie, Ontario P6A 0A8

Canada

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Thunder Bay, Ontario P7B 6V4

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Windsor, Ontario N8W 2X3

Canada

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Chicoutimi, Quebec G7H 5H6

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Lévis, Quebec G6V 3Z1

Canada

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Montreal, Quebec H1T 2M4

Canada

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Montreal, Quebec H2X 3E4

Canada

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Montreal, Quebec H4A 3J1

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Québec, Quebec G1S 4L8

Canada

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Saskatoon, Saskatchewan S7N 4H4

Canada

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Concepción, 4070196

Chile

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La Serena, 1720430

Chile

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Port Montt, 5500243

Chile

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Providencia, 7510032

Chile

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Santiago, 7620157

Chile

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Santiago, 8150215

Chile

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Santiago, 8330032

Chile

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Santiago, 8330336

Chile

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Temuco, 4810218

Chile

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Viña del Mar, 2520000

Chile

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Baoding, 071000

China

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Beijing, 100021

China

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Beijing, 100039

China

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Beijing, 100142

China

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Beijing, 100191

China

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Beijing, 100730

China

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Bengbu, 233004

China

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Binzhou, 256606

China

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Cangzhou, 061001

China

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Changchun, 130021

China

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Changsha, 410008

China

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Chengdu, 610042

China

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Chengdu, 610072

China

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Chifeng, 024000

China

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Dalian, 116011

China

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Foshan, 528000

China

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Fuzhou, 350014

China

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Guangzhou, 510060

China

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Guangzhou, 510080

China

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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

China

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Hangzhou, 310022

China

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Harbin, 150081

China

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Hefei, 230001

China

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Hefei, 230012

China

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Hefei, 230022

China

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Hefei, 230601

China

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Hohhot, 010017

China

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Huizhou, 516001

China

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Jinzhou, 121001

China

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Lanzhou, 730050

China

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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

China

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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

China

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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

China

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Wuhan, 430060

China

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Wuhan, 430079

China

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Xi'an, 710004

China

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Xiangfan, 441021

China

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Xinxiang, 453100

China

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Xuzhou, 221002

China

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Xuzhou, 221009

China

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Zunyi, 563100

China

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Barranquilla, 080020

Colombia

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Bogotá, 110221

Colombia

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Cali, 760042

Colombia

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Medellín, 050030

Colombia

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Montería, 23001

Colombia

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Valledupar, 200001

Colombia

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Osijek, 31000

Croatia

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Rijeka, 51000

Croatia

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Split, 21000

Croatia

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Zadar, 23000

Croatia

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Zagreb, 10000

Croatia

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Brno, 625 00

Czechia

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Hořovice, 26831

Czechia

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Liberec, 46063

Czechia

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Pardubice, 532 03

Czechia

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Prague, 150 06

Czechia

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Tallinn, 10138

Estonia

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Tallinn, 11619

Estonia

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Tartu, 50406

Estonia

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Angers, 49100

France

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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

France

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Epagny Metz-Tessy, 74370

France

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Lille, 59000

France

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Lyon, 75004

France

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Marseille, 13273

France

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Montpellier, 34298

France

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Nantes, 44277

France

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Nîmes, 30029

France

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Paris, 75005

France

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Pierre-Bénite, 69495

France

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Plerin SUR MER, 22190

France

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Rennes, 35000

France

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Rouen, 76021

France

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Saint-Cloud, 92210

France

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Saint-Herblain, 44800

France

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Saint-Priest-en-Jarez, 42270

France

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Strasbourg, 67200

France

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Toulouse, 31059

France

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Vandœuvre-lès-Nancy, 54519

France

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Villejuif, 94805

France

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Batumi, 6000

Georgia

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Tbilisi, 0102

Georgia

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Tbilisi, 0112

Georgia

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Tbilisi, 0179

Georgia

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Tbilisi, 0186

Georgia

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Tbilisi, 114

Georgia

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Tbilisi, 160

Georgia

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Aachen, 52074

Germany

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Berlin, 12559

Germany

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Cologne, 51067

Germany

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Darmstadt, 64283

Germany

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Deggendorf, 94469

Germany

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Dessau, 6847

Germany

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Dresden, 01127

Germany

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Düsseldorf, 40235

Germany

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Essen, 45130

Germany

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Freudenstadt, 72250

Germany

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Georgsmarienhütte, 49124

Germany

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Hamburg, 20357

Germany

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Hamburg, 22457

Germany

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Hamm, 59073

Germany

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Hanau, 63450

Germany

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Hanover, 30177

Germany

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Hanover, 30559

Germany

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Heidelberg, 69120

Germany

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Karlsruhe, 76135

Germany

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Koblenz, 56068

Germany

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Mainz, 55131

Germany

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Nürtingen, 72622

Germany

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Offenburg, 77654

Germany

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Rostock, 18057

Germany

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Saarbrücken, 66113

Germany

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Schweinfurt, 97421

Germany

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Speyer, 67346

Germany

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Torgau, 4860

Germany

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Wiesbaden, 65189

Germany

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Wiesbaden, 65199

Germany

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Witten, 58452

Germany

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Worms, 67550

Germany

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Wuppertal, 42283

Germany

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Athens, 115 22

Greece

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Athens, 11527, GR

Greece

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Athens, 11528

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Athens, 11528

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A Coruña, 15006

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United Kingdom