A Long-term Safety Study of Infliximab (Remicade)

NCT ID: NCT00261976

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2971 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-02-28

Study Completion Date

2012-03-31

Brief Summary

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This is a study evaluating the long-term safety of infliximab (Remicade)

Detailed Description

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The purpose of this study is to collect long-term safety information on infliximab (Remicade) from patients who participate in research studies using those drugs. All patients in these studies are being asked to participate in this long-term safety follow-up study which will provide important information about the study drug. The long-term effect of the study drug on survival, serious infections, new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period. Additional information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if you received infliximab (Remicade) after the end of the primary study. Study participation in this research study is 5 years after the end of the primary study. Questionnaires will be completed about patient's health and the occurrence of these safety events at intervals of 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after patients complete participation in the primary study.

Conditions

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Arthritis, Rheumatoid Crohn Disease Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients in infliximab clinical studies

All patients enrolled in selected Centocor sponsored infliximab clinical studies.

Infliximab (Remicade)

Intervention Type DRUG

This is an non-interventional study. Participants took the study product as part of their medical routine.

Interventions

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Infliximab (Remicade)

This is an non-interventional study. Participants took the study product as part of their medical routine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies that require long-term safety follow-up (ie, primary studies). Patients must have received at least 1 dose of study agent to be eligible for participation in the study

Exclusion Criteria

\- Did not previously participate in Centocor sponsored infliximab clinical studies.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centocor BV

INDUSTRY

Sponsor Role collaborator

Centocor, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Montgomery, Alabama, United States

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Paradise Valley, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Fresno, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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Madera, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Rancho Mirage, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Stanford, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Hamden, Connecticut, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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Waterbury, Connecticut, United States

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Aventura, Florida, United States

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Largo, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Palm Harbor, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Coeur d'Alene, Idaho, United States

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Chicago, Illinois, United States

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Evanston, Illinois, United States

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Gurnee, Illinois, United States

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Maywood, Illinois, United States

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Normal, Illinois, United States

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Rockford, Illinois, United States

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Springfield, Illinois, United States

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Indianapolis, Indiana, United States

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Iowa City, Iowa, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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Louisville, Kentucky, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Greenbelt, Maryland, United States

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Wheaton, Maryland, United States

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Andover, Massachusetts, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroti, Michigan, United States

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East Lansing, Michigan, United States

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Grand Rapids, Michigan, United States

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Edina, Minnesota, United States

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Fridley, Minnesota, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Reno, Nevada, United States

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Voorhees Township, New Jersey, United States

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Manhasset, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Portland, Oregon, United States

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Bethlehem, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Philadelphia Pennsylvan, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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North Charleston, South Carolina, United States

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Goodlettsville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Burlington, Vermont, United States

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Salem, Virginia, United States

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Bellevue, Washington, United States

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Kirkland, Washington, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Cp, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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Graz, , Austria

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Innsbruck, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Diepenbeek, , Belgium

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Edegem, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Richmond, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Kitchener, Ontario, Canada

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London, Ontario, Canada

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Markham, Ontario, Canada

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Newmarket, Ontario, Canada

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North Bay, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Waterloo, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Ste-Foy, Quebec, Canada

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Halifax, , Canada

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Hamilton Ontario, , Canada

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Montreal, , Canada

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Saskatoon, , Canada

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Aarhus, , Denmark

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Hellerup, , Denmark

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Hvidovre, , Denmark

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København NV, , Denmark

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Odense, , Denmark

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Helsinki, , Finland

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Hus, , Finland

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Jyväskylä, , Finland

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Pikonlinna, , Finland

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Créteil, , France

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Montpellier, , France

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Nantes, , France

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Nice, , France

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Paris, , France

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Pierre-Bénite, , France

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Poitiers, , France

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Berlin, , Germany

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Bochum, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Erlangen, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Münster, , Germany

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Oldenburg, , Germany

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Würzburg, , Germany

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Wÿrzburg, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Dublin, , Ireland

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Haifa, , Israel

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Tel Aviv, , Israel

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Amsterdam-Zuidoost, , Netherlands

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Maastricht, , Netherlands

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Rotterdam, , Netherlands

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Utrecht, , Netherlands

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Oslo, , Norway

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Bialystok, , Poland

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Lublin, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Włoszczowa, , Poland

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Barcelona, , Spain

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Buenos Aires, , Spain

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Córdoba, , Spain

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Federal, , Spain

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Madrid, , Spain

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Gothenburg, , Sweden

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Geneva, , Switzerland

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Zurich, , Switzerland

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Bath, , United Kingdom

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Birmingham, , United Kingdom

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Cambridge, , United Kingdom

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Cannock, , United Kingdom

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Leeds, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Norwich, , United Kingdom

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Oxford, , United Kingdom

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Countries

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United States Argentina Austria Belgium Canada Denmark Finland France Germany Hungary Ireland Israel Netherlands Norway Poland Spain Sweden Switzerland United Kingdom

Related Links

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Other Identifiers

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C0168T45

Identifier Type: OTHER

Identifier Source: secondary_id

CR004780

Identifier Type: -

Identifier Source: org_study_id

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