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NCT07225504PHASE3Recruiting

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Novartis Pharmaceuticals

Start Date

11/11/2025

Completion Date

1/2/2034

Summary

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Detailed Description

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, parallel-group, event-driven study to evaluate the efficacy, safety and tolerability of remibrutinib in SPMS patients. Approximately 1275 eligible participants will be randomized to receive either remibrutinib or matching placebo. The study consists of an event-driven Core Part with double-blind treatment, followed by an Extension Part with open-label remibrutinib treatment.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Signed informed consent must be obtained prior to any assessment performed. * Male or female participants aged 18-65 (inclusive) at Screening. * Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018), with current SPMS in accordance with the revised clinical course (Lublin et al 2014) at Screening * Absence of documented clinical relapses in the 24 months before Screening and randomization. * EDSS score of 3.0 to 6.0 (inclusive) at Screening. * Documented evidence of disability progression in the 12 months before Screening. Exclusion Criteria: * Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)). * History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS). * Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures. * Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML. * Women of childbearing potential (WOCBP), unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for at least 1 week after stopping study treatment. * Significant bleeding risk or coagulation disorders, at Screening. * Use of exclusionary medication prior to Screening/randomization as listed in the protocol. Other protocol-defined inclusion/exclusion critria may apply

Interventions

DRUG

Remibrutinib (blinded)

DRUG

Placebo

DRUG

Remibrutinib (Open label)

Interested in This Trial?

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Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Locations

Alabama Neurology Associates PC

Birmingham, Alabama 35209

United States

Ctr for Neurology and Spine

Phoenix, Arizona 85018

United States

AZ Integrated Neuro and Spine

Phoenix, Arizona 85037

United States

Center for Neurosciences

Tucson, Arizona 85718

United States

Fullerton Neuro and Headache Ctr

Fullerton, California 92835

United States

Regina Berkovich MD PhD Inc

West Hollywood, California 90048

United States

UC Health Neuroscience Ctr

Aurora, Colorado 80045

United States

Georgetown University Hospital

Washington D.C., District of Columbia 20007

United States

Medstar Washington Hosp Ctr

Washington D.C., District of Columbia 20010

United States

Neurology of Central FL Res Ctr

Altamonte Springs, Florida 32714

United States

UF Health Cancer Center

Gainesville, Florida 32610

United States

Homestead Assoc In Research Inc

Homestead, Florida 33033

United States

Neurology Associates PA

Maitland, Florida 32751

United States

Miami NS Ins Baptist Health S FL

Miami, Florida 33176

United States

Aqualane Clinical Research

Naples, Florida 34105

United States

Orlando Health Clinical Trials

Orlando, Florida 32806

United States

Comprehensive Neurology Clinic

Orlando, Florida 32825

United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida 32174

United States

Axiom Brain Health

Tampa, Florida 33609

United States

University Of South Florida

Tampa, Florida 33612

United States

Joi Life Wellness Group LLC

Smyrna, Georgia 30080

United States

Hawaii Pacific Neuroscience LLC

Honolulu, Hawaii 96817

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

University of Kansas Hospital

Kansas City, Kansas 66160

United States

Mid Atlantic Epilepsy and Sleep Ctr

Bethesda, Maryland 20817-1807

United States

Neuro Institute of New England P C

Foxborough, Massachusetts 02035

United States

Elliot Lewis MS Center

Wellesley, Massachusetts 02481

United States

U Mass Memorial Medical Center

Worchester, Massachusetts 01605

United States

Michigan Institute of Neurological

Farmington Hills, Michigan 48334

United States

University of New Mexico Hospital

Albuquerque, New Mexico 87106

United States

Premier Neurology

Greenville, South Carolina 29605

United States

Neurology Clinic PC

Cordova, Tennessee 38018

United States

Carum Research

Dallas, Texas 75231

United States

Saturn Research Solution

Plano, Texas 75024

United States

Citta Clinical Research

Spokane, Washington 99202

United States

Novartis Investigative Site

CABA, Buenos Aires C1428AQK

Argentina

Novartis Investigative Site

Capital Federal, Buenos Aires 1424

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Buenos Aires, Buenos Aires F.D. 1221

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Bombal, Mendoza Province M5500DXO

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San Juan, San Juan Province J5402DIL

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Rosario, Santa Fe Province 2000

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Rosario, Santa Fe Province S2000DSW

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Santiago del Estero, Santiago del Estero Province G4200AIR

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San Miguel de, Tucumán Province T4000

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Buenos Aires, C1012AAR

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Caba, C1055AAF

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CABA, C1181ACH

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Caba, C1182

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Caba, C1424BYD

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Kogarah, New South Wales 2217

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New Lambton Heights, New South Wales 2305

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Westmead, New South Wales 2145

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Clayton, Victoria 3168

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Heidelberg, Victoria 3084

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Murdoch, Western Australia 6150

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Southport, 4215

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Innsbruck, Tyrol 6020

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Linz, Upper Austria 4020

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Linz, 4020

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Vienna, 1180

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Leuven, Vlaams Brabant 3000

Belgium

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Roeselare, West-Vlaanderen 8800

Belgium

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Bonheiden, 2820

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Brussels, 1070

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Porto Alegre, Rio Grande do Sul 90430-001

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Porto Alegre, Rio Grande do Sul 90560-032

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Porto Alegre, Rio Grande do Sul 90620-130

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Joinville, Santa Catarina 89202-165

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Santo André, São Paulo 09040 010

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São Paulo, São Paulo 04076-004

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Pleven, 5800

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Sofia, 1113

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Sofia, 1309

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Sofia, 1407

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Sofia, 1408

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Sofia, 1431

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Sofia, 1510

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Sofia, 1606

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Vancouver, British Columbia V6T 2A1

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Halifax, Nova Scotia B3H 4K4

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Ottawa, Ontario K1H 8L6

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Lévis, Quebec G6W 0M5

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Montreal, Quebec H2X 1R9

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Montreal, Quebec H3A 2B4

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Montreal, Quebec H4A 3T2

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Québec, Quebec G1J 1Z4

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Sherbrooke, Quebec J1H 5N4

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Guangzhou, Guangdong 510080

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Zhengzhou, Henan 450003

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Wuhan, Hubei 430030

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Wuhan, Hubei 430060

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Hohhot, Inner Mongolia 010017

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Suzhou, Jiangsu 215004

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Changchun, Jilin 130021

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Shenyang, Liaoning 110011

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Yinchuan, Ningxia 750004

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Xianyang, Shaanxi 712000

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Taiyuan, Shanxi 030001

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Hangzhou, Zhejiang 310002

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Hangzhou, Zhejiang 310016

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Wenzhou, Zhejiang 325000

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Beijing, 100034

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Beijing, 100070

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Chongqing, 400016

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Shanghai, 200040

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Tianjin, 300052

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Barranquilla, Atlántico 080020

Colombia

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Bogotá, 111321

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Medellín, 050001

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Medellín, 050034

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Varaždin, Varaždin County 42000

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Brno, 602 00

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Hradec Králové, 500 05

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Jihlava, 586 01

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Prague, 140 59

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Prague, 150 06

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Teplice, 415029

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Aarhus N, 8200

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Esbjerg, 6700

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Tallinn, 11315

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Tartu, 51014

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Limoges, Haute Vienne 87000

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Ajaccio, 20090

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Amiens, 80054

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Clermont-Ferrand, 63003

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Gonesse, 95500

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Grenoble, 38043

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Lille, 59000

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Lille, 59037

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Montpellier, 34090

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Nancy, 54035

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Nice, 06000

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Nîmes, 30029

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Orsay, 91400

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Paris, 75013

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Paris, 75940

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Poitiers, 86021

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Rennes, 35033

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Rouen, 76031

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Strasbourg, 67000

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Toulouse, 31059

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Tours, 37044

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Freiburg im Breisgau, Baden-Wurttemberg 79106

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Mannheim, Baden-Wurttemberg 68167

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Munich, Bavaria 81377

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Unterhaching, Bavaria 82008

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Cottbus, Brandenburg 03048

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Halle, Saxony-Anhalt 06120

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Erfurt, 99089

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Giessen, 35392

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Greifswald, 17475

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Heidelberg, 69120

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Ibbenbueren, 49477

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Itzehoe, 25524

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Tübingen, 72076

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Ulm, 89073

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Athens, 115 28

Greece

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Chaïdári, 124 62

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Ioannina, 455 00

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Pécs, Baranya 7623

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Budapest, 1033

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Budapest, 1044

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Budapest, 1106

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Kistarcsa, 2143

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Tatabánya, H 2800

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Gurugram, Haryana 122011

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Mangalore, Karnataka 575003

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Kochi, Kerala 682025

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New Delhi, National Capital Territory of Delhi 110029

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New Delhi, National Capital Territory of Delhi 110060

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Chandigarh, Punjab 160012

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Vellore, Tamil Nadu 632 004

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Hyderabad, Telangana 500082

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Ashkelon, 7830604

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Hadera, 3820302

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Haifa, 3436212

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Jerusalem, 9112001

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Ramat Gan, 5265601

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Rehovot, 7661041

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Tel Aviv, 6423906

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Ẕerifin, 7030000

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Ancona, AN 60020

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Bergamo, BG 24127

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Foggia, FG 71122

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Pozzilli, IS 86077

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Pavia, PV 27100

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Roma, RM 00133

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Roma, RM 00189

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Gallarate, VA 21013

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Naples, 80138

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Kaunas, 3007

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Chihuahua City, Chihuahua 31203

Mexico

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Benito Juárez, Mexico City 03100

Mexico

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Mexico City, Mexico City 06700

Mexico

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San Luis Potosí City, 78216

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Arnhem, Gelderland 6815 AD

Netherlands

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's-Hertogenbosch, North Brabant 5223 GZ

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Amsterdam, North Holland 1081 HV

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Leiden, 2334 CN

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Krakow, Lesser Poland Voivodeship 30-727

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Krakow, Poland 31 531

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Bydgoszcz, Woj Kujawsko Pomorskie 85-796

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Chojnice, 89-600

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Katowice, 40-081

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Katowice, 40-686

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Lodz, 93-113

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Lublin, 20-410

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Rzeszów, 35-323

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Skorzewo, 60-185

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Warsaw, 01-684

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Zabrze, 41-800

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Żory, 44-240

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Braga, 4710243

Portugal

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Lisbon, 1169-050

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Lisbon, 1349-019

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Lisbon, 1649-035

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Porto, 4200 319

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Constanța, ROM 900123

Romania

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Bucharest, 040215

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Campulung Muscel, 115100

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Bratislava, Slovakia 826 06

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Trnava, Slovakia 917 02

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Bratislava, 851 01

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Komárno, 945 05

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Nitra, 950 01

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Cape Town, Western Cape 7405

South Africa

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Barcelona, Barcelona 08035

Spain

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L'Hospitalet de Llobregat, Barcelona 08907

Spain

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Jerez de la Frontera, Cadiz 11407

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Albacete, Castille-La Mancha 02006

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Logroño, La Rioja 26006

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Pozuelo de Alarcón, Madrid 28223

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Torrejón de Ardoz, Madrid 28850

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El Palmar, Murcia 30120

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Castilleja de la Cuesta, Sevilla 41950

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Valencia, Valencia 46017

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Barakaldo, Vizcaya 48903

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Alicante, 03010

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Las Palmas GC, 35010

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Lleida, 25198

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Madrid, 28006

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Madrid, 28009

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Madrid, 28034

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Madrid, 28040

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Málaga, 29010

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Salamanca, 37007

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Valencia, 46026

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Bern, 3010

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Lausanne, 1011

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Brighton, East Sussex BN2 5BE

United Kingdom

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Romford, Essex RM7 0AG

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Coventry, CV2 2DX

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Glasgow, EH9 1LF

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Leeds, LS1 3EX

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London, E1 2AT

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Nottingham, NG7 2UH

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