Last updated on September 2018

A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis


Brief description of study

Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.

Clinical Study Identifier: NCT02597933

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University of California
Los Angeles, CA United States

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University of California
Sacramento, CA United States

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University of California
San Francisco, CA United States

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Stanford University Medical Center
Stanford, CA United States

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University of Colorado Denver
Aurora, CO United States

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Yale University School of Medicine
New Haven, CT United States

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Georgetown University
Washington, D.C., United States

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University of Florida College of Medicine
Jacksonville, FL United States

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University of Miami
Miami, FL United States

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The Emory Clinic
Atlanta, GA United States

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Northwestern University
Chicago, IL United States

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University of Chicago
Chicago, IL United States

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University of Iowa
Iowa City, IA United States

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Univeristy of Kansas Medical Center
Kansas City, KS United States

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University of Louisville
Louisville, KY United States

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Tulane University Hospital and Clinic
New Orleans, LA United States

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Johns Hopkins Scleroderma Center
Baltimore, MD United States

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Massachusetts General Hospital
Boston, MA United States

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Boston Medical Center
Boston, MA United States

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University of Michigan Health System
Ann Arbor, MI United States

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Henry Ford Health System
Detroit, MI United States

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University of Minnesota Masonic Cancer Center
Minneapolis, MN United States

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Mayo Clinic-Rochester
Rochester, MN United States

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The Lung Research Center, LLC
Chesterfield, MO United States

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Washington University School of Medicine
Saint Louis, MO United States

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Hospital for Special Surgery
New York, NY United States

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Ichan School of Medicine at Mount Sinai
New York, NY United States

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Columbia University Medical Center-New York Presbyterian Hospital
New York, NY United States

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Duke University Medical Center
Durham, NC United States

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University of Cincinnati Health
Cincinnati, OH United States

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Cole Eye Institute
Cleveland, OH United States

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University of Toledo
Toledo, OH United States

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Penn State Milton S. Hershey Medical Center
Hershey, PA United States

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The Univ of PA Perelman Ctr for Advncd Medicine
Philadelphia, PA United States

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Thomas Jefferson University
Philadelphia, PA United States

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Temple University Hospital
Philadelphia, PA United States

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Medical University of South Carolina
Charleston, SC United States

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University of South Carolina
Columbia, SC United States

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Vanderbilt Pulmonary Clinic
Nashville, TN United States

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University of Texas Southwestern Medical Center
Dallas, TX United States

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The University Of Texas at Houston
Houston, TX United States

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University of Utah Health Sciences Center
Salt Lake City, UT United States

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Inova Fairfax Medical Campus
Falls Church, VA United States

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Virginia Mason Medical Center
Seattle, WA United States

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University of Washington
Seattle, WA United States

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Froedtert Hospital
Milwaukee, WI United States

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Hospital Militar Central
Buenos Aires, Argentina

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Centro de Investigaciones Metab licas (CINME)
C.a.b.a, Argentina

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APRILLUS
Ciudad Autonoma Buenos Aires, Argentina

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CEMER-Centro Medico De Enfermedades Respiratorias
Florida, FL Argentina

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Royal Prince Alfred Hospital, Respiratory Dept
Camperdown, Australia

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Concord Repatriation General Hospital
Concord, Australia

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Liverpool Hospital
Sydney, Australia

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Royal Adelaide Hospital
Adelaide, Australia

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St Vincents Melbourne
Fitzroy, Australia

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Brussels - UNIV Erasme
Bruxelles, Belgium

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Brussels - UNIV St-Luc
Bruxelles, Belgium

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UNIV UZ Gent
Gent, Belgium

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UZ Leuven
Leuven, Belgium

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Centre Hospitalier Universitaire de Li ge
Liège, Belgium

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Edumed - Educacao e Saude SA
Curitiba, Brazil

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Saint Joseph's Healthcare
Hamilton, ON Canada

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Mount Sinai Hospital
Toronto, ON Canada

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Jewish General Hospital
Montreal, QC Canada

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HSCM
Montreal, QC Canada

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Hospital Cl nico Reg. de Concepci n "Dr. G. Grant Benavente"
Concepción, Chile

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Centro de Investigaci n del Maule
Talca, Chile

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Peking Union Medical College Hospital
Beijing, China

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Beijing Chao-Yang Hospital
Beijing, China

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Beijing Hospital
Beijing, China

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First Hospital of Jilin University
Changchun, China

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West China Hospital
Chengdu, China

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The First Affiliated Hospital of Anhui Medical University
Hefei, China

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Huashan Hospital, Fudan University
Shanghai, China

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The First Hospital of Chinese Medical University
Shenyang, China

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Zhuzhou Central Hospital
Zhuzhou, China

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Institute of Rheumathology Prague
Prague, Czechia

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Thomayer Hospital
Praha 4, Czechia

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Odense Universitetshospital
Odense, Denmark

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Århus, Denmark

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Helsinki, Finland

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Turku, Finland

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Bobigny, France

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Brest, France

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Lille cedex, France

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Lille, France

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Montpellier, France

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Nantes, France

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Nice, France

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Rennes, France

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Rouen cedex, France

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Toulouse, France

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Tours, France

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Kerckhoff-Klinik, Bad Nauheim
Bad Nauheim, Germany

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Krankenhaus, Donaustauf
Donaustauf, Germany

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Universit tsklinikum Carl Gustav Carus Dresden
Dresden, Germany

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Erlangen, Germany

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Greifswald, Germany

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Hamburg, Germany

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Hannover, Germany

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Heidelberg, Germany

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Kiel, Germany

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Köln, Germany

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General Hospital of Athens "Laiko"
Athens, Greece

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Semmelweis University, Dept. Pulmonology
Budapest, Hungary

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Sanjivani Superspeciality Hospital Pvt. Ltd.
Ahmedabad, India

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St John's Medical College
Bangalore, India

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Postgraduate Institute of Medical Education And Research
Chandigarh, India

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Care Hospital
Hyderabad, India

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Nizam's Institute of Medical Sciences
Hyderabad, India

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Fortis Hospital
Kolkata, India

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P.D. Hinduja National Hospital
Mumbai, India

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Getwell Hospital & Research Institute
Nagpur, India

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All India Institute of Medical Science
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Sir Gangaram Hospital
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Jehangir Clinical Development Centre Pvt. Ltd.
Pune, India

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B.J. Medical College and Sasoon General Hospital
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Vellore, India

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Cork University Hospital
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Haifa, Israel

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Haifa, Israel

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Petah Tiqwa, Israel

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Tel Aviv, Israel

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Az. Ospedaliere Umberto I di Ancona
Ancona, Italy

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Genova, Italy

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Padova, Italy

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Roma, Italy

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Tosei General Hospital
Aichi, Seto, Japan

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Fukuoka, Kurume, Japan

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Hokkaido, Sapporo, Japan

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Iwate, Morioka, Japan

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Kanagawa, Kawasaki, Japan

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Kanagawa, Sagamihara, Japan

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Kanagawa, Yokohama, Japan

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Kyoto, Kyoto, Japan

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Nagasaki, Nagasaki, Japan

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Osaka, Osakasayama, Japan

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Osaka, Sakai, Japan

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Osaka, Takatsuki, Japan

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Saitama, Iruma-gun, Japan

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Shizuoka, Hamamatsu, Japan

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Tokushima, Tokushima, Japan

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Tokyo, Bunkyo-Ku, Japan

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Tokyo, Ota-ku, Japan

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Tokyo, Shinjyuku-ku, Japan

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Ciudad de México, Mexico

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Amsterdam, Netherlands

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Nijmegen, Netherlands

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Oslo, Norway

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Tromsø, Norway

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Bydgoszcz, Poland

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Krakow, Poland

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Lublin, Poland

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Lublin, Poland

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Almada, Portugal

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Amadora, Portugal

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Valencia, Spain

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Valencia, Spain

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Vigo, Spain

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Clinical Rheumatology Research Center Sahlgrenska
Gothenburg, Sweden

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Kantonspital St. Gallen, Rheumatologie Department
St. Gallen, Switzerland

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Zürich, Switzerland

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Glasgow, United Kingdom

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London, United Kingdom

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London, United Kingdom

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