Dimethyl Fumarate (DMF) Observational Study

NCT ID: NCT02047097

Last Updated: 2023-05-24

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

5487 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-19

Study Completion Date

2022-10-31

Brief Summary

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The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

Detailed Description

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Patients aged 12 to under 18 may be included where enrollment of pediatric patients in this study is considered observational and is permissible by local regulations.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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dimethyl fumarate (DMF)

Patients with multiple sclerosis receiving dimethyl fumarate (DMF) under routine clinical care

dimethyl fumarate

Intervention Type DRUG

Provided under routine clinical care

Interventions

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dimethyl fumarate

Provided under routine clinical care

Intervention Type DRUG

Other Intervention Names

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Tecfidera DMF BG00012

Eligibility Criteria

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Inclusion Criteria

\- Patients with multiple sclerosis (MS) who are newly initiating treatment with dimethyl fumarate (DMF) under routine clinical care are eligible to participate in the study.

Exclusion Criteria

* Patients with previous exposure to dimethyl fumarate (DMF), Fumaderm (fumaric acid esters), or compounded fumarates.
* Patients participating in other clinical studies.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Gilbert, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Fullerton, California, United States

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Hanford, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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San Francisco, California, United States

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Santa Ana, California, United States

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Aurora, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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Danbury, Connecticut, United States

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Derby, Connecticut, United States

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Hartford, Connecticut, United States

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Norwich, Connecticut, United States

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Dover, Delaware, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Boca Raton, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Lighthouse PT, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Columbus, Georgia, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Evanston, Illinois, United States

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Herrin, Illinois, United States

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Peoria, Illinois, United States

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Winfield, Illinois, United States

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Elkhart, Indiana, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Des Moines, Iowa, United States

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Waterloo, Iowa, United States

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Overland Park, Kansas, United States

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Overland Park, Kansas, United States

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Henderson, Kentucky, United States

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Louisville, Kentucky, United States

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Hammond, Louisiana, United States

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New Orleans, Louisiana, United States

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Rockport, Maine, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Bethesda, Maryland, United States

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Cumberland, Maryland, United States

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Glen Burnie, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Foxborough, Massachusetts, United States

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Jamaica Plain, Massachusetts, United States

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Lexington, Massachusetts, United States

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Wellesley, Massachusetts, United States

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Worcester, Massachusetts, United States

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Ann Arbor, Michigan, United States

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East Lansing, Michigan, United States

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Farmington Hills, Michigan, United States

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West Bloomfield, Michigan, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Ocean Springs, Mississippi, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Great Falls, Montana, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Wahoo, Nebraska, United States

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Las Vegas, Nevada, United States

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Concord, New Hampshire, United States

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Audubon, New Jersey, United States

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Flemington, New Jersey, United States

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Hackensack, New Jersey, United States

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Livingston, New Jersey, United States

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New Brunswick, New Jersey, United States

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Newark, New Jersey, United States

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Stratford, New Jersey, United States

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Toms River, New Jersey, United States

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West Long Branch, New Jersey, United States

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Albany, New York, United States

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Cedarhurst, New York, United States

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East Meadow, New York, United States

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Kingston, New York, United States

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New York, New York, United States

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New York, New York, United States

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Patchogue, New York, United States

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Plainview, New York, United States

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Syracuse, New York, United States

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Syracuse, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Hendersonville, North Carolina, United States

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Pinehurst, 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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Bismarck, North Dakota, United States

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Canton, Ohio, United States

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Centerville, 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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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Abington, Pennsylvania, United States

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Allentown, Pennsylvania, United States

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Greensburg, Pennsylvania, United States

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Meadowbrook, Pennsylvania, United States

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Monroeville, Pennsylvania, United States

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Natrona Heights, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greenville, South Carolina, United States

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Spartanburg, South Carolina, United States

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Franklin, Tennessee, United States

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Knoxville, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Colleyville, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, 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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Tacoma, Washington, United States

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Tacoma, Washington, United States

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Green Bay, Wisconsin, United States

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Green Bay, Wisconsin, United States

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Green Bay, Wisconsin, United States

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Green Bay, Wisconsin, United States

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La Crosse, Wisconsin, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Neenah, Wisconsin, United States

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Waukesha, Wisconsin, United States

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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Vicente López, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Ciudad Autonoma Buenos Aires, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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Mendoza, , Argentina

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Salta, , Argentina

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San Juan, , Argentina

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Santiago del Estero, , Argentina

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Villa Nueva, , Argentina

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Camperdown, New South Wales, Australia

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Concord, New South Wales, Australia

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Kogarah, New South Wales, Australia

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Liverpool, New South Wales, Australia

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New Lambton Heights, New South Wales, Australia

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Randwick, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Sydney, New South Wales, Australia

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Westmead, New South Wales, Australia

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Auchenflower, Queensland, Australia

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Gold Coast, Queensland, Australia

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Bedford Park, South Australia, Australia

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Kent Town, South Australia, Australia

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Box Hill, Victoria, Australia

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Clayton, Victoria, Australia

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Geelong, Victoria, Australia

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Heidelberg, Victoria, Australia

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Melbourne, Victoria, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Nedlands, Western Australia, Australia

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Amstetten, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Calgary, Alberta, Canada

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Burnaby, British Columbia, Canada

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Victoria, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Sydney, Nova Scotia, Canada

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Cambridge, Ontario, Canada

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London, Ontario, Canada

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Milton, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Gatineau, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Regina, Saskatchewan, Canada

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Brno, , Czechia

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Hradec Králové, , Czechia

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Jihlava, , Czechia

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Olomouc, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Teplice, , Czechia

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Aarhus C, , Denmark

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Esbjerg, , Denmark

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Glostrup Municipality, , Denmark

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Odense C, , Denmark

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Sønderborg, , Denmark

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Montluçon, Allier, France

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Mulhouse, Haut Rhin, France

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Toulouse, Haute Garonne, France

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Pringy, Haute Savoie, France

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Rueil-Malmaison, Hauts De Seine, France

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Dax, Landes, France

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Agen, Lot Et Garonne, France

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Perpignan, Pyrenees Orientales, France

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Bron, Rhone, France

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La Roche-sur-Yon, Vendee, France

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Épinal, Vosges, France

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Gonesse, , France

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Rambouillet, , France

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Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Heidelberg, Baden-Wurttemberg, Germany

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Heidenheim, Baden-Wurttemberg, Germany

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Ladenburg, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

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Mannheim, Baden-Wurttemberg, Germany

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Ravensburg, Baden-Wurttemberg, Germany

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Singen, Baden-Wurttemberg, Germany

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Sinsheim, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Ulm, Baden-Wurttemberg, Germany

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Alzenau in Unterfranken, Bavaria, Germany

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Bayreuth, Bavaria, Germany

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Bogen, Bavaria, Germany

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Erlangen, Bavaria, Germany

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Landshut, Bavaria, Germany

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Munich, Bavaria, Germany

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Neuburg am Inn, Bavaria, Germany

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Nuremberg, Bavaria, Germany

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Nuremberg, Bavaria, Germany

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Regensburg, Bavaria, Germany

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Unterhaching, Bavaria, Germany

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Wolfratshausen, Bavaria, Germany

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Würzburg, Bavaria, Germany

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Butzbach, Hesse, Germany

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Eltville, Hesse, Germany

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Erbach im Odenwald, Hesse, Germany

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Eschwege, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Frankfurt am Main, Hesse, Germany

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Gelnhausen, Hesse, Germany

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Giessen, Hesse, Germany

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Gladenbach, Hesse, Germany

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Kassel, Hesse, Germany

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Wiesbaden, Hesse, Germany

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Buchholz, Lower Saxony, Germany

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Göttingen, Lower Saxony, Germany

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Oldenburg, Lower Saxony, Germany

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Stade, Lower Saxony, Germany

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Aachen, North Rhine-Westphalia, Germany

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Aachen, North Rhine-Westphalia, Germany

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Bad Honnef, North Rhine-Westphalia, Germany

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Bergisch Gladbach, North Rhine-Westphalia, Germany

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Bielefeld, North Rhine-Westphalia, Germany

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Bochum, North Rhine-Westphalia, Germany

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Bonn, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Cologne, North Rhine-Westphalia, Germany

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Düsseldorf, North Rhine-Westphalia, Germany

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Essen, North Rhine-Westphalia, Germany

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Hagen, North Rhine-Westphalia, Germany

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Remscheid, North Rhine-Westphalia, Germany

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Siegen, North Rhine-Westphalia, Germany

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Willich, North Rhine-Westphalia, Germany

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Wuppertal, North Rhine-Westphalia, Germany

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Frankenthal, Rhineland-Palatinate, Germany

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Kandel, Rhineland-Palatinate, Germany

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Katzenelnbogen, Rhineland-Palatinate, Germany

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Rülzheim, Rhineland-Palatinate, Germany

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Trier, Rhineland-Palatinate, Germany

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Chemnitz, Saxony, Germany

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Görlitz, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Wermsdorf, Saxony, Germany

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Halle, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Kiel, Schleswig-Holstein, Germany

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Eisenach, Thuringia, Germany

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Erfurt, Thuringia, Germany

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Jena, Thuringia, Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Neusäß, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Eger, , Hungary

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Győr, , Hungary

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Miskolc, , Hungary

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Szeged, , Hungary

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Tatabánya, , Hungary

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Zalaegerszeg, , Hungary

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Dublin, , Ireland

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Dublin, , Ireland

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Torrette, Ancona, Italy

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Montichiari, Brescia, Italy

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Pozzilli, Isernia, Italy

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Legnano, Milano, Italy

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Fidenza, Parma, Italy

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Orbassano, Torino, Italy

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Gallarate, Varese, Italy

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Bari, , Italy

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Bergamo, , Italy

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Bologna, , Italy

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Cagliari, , Italy

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Catanzaro, , Italy

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Genova, , Italy

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Messina, , Italy

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Milan, , Italy

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Modena, , Italy

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Napoli, , Italy

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Palermo, , Italy

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Palermo, , Italy

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Parma, , Italy

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Pavia, , Italy

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Perugia, , Italy

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Pordenone, , Italy

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Reggio Emilia, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Breda, , Netherlands

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Eindhoven, , Netherlands

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Geldrop, , Netherlands

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Geleen, , Netherlands

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Hoorn, , Netherlands

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Leeuwarden, , Netherlands

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Leiden, , Netherlands

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Nieuwegein, , Netherlands

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Nijmegen, , Netherlands

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Tilburg, , Netherlands

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Venlo, , Netherlands

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Christchurch, , New Zealand

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Dunedin, , New Zealand

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Hamilton, , New Zealand

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Bodø, , Norway

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Namsos, , Norway

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Ochojec, Katowice, Poland

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Gdansk, , Poland

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Gmina Końskie, , Poland

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Grudziądz, , Poland

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Głogów Małopolski, , Poland

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Katowice, , Poland

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Katowice, , Poland

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Konstancin-Jeziorna, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Zabrze, , Poland

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Amadora, , Portugal

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Braga, , Portugal

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Guimarães, , Portugal

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Matosinhos Municipality, , Portugal

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Penafiel, , Portugal

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Santarém, , Portugal

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Viana do Castelo, , Portugal

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Vila Nova de Gaia, , Portugal

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Guaynabo, , Puerto Rico

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San Juan, , Puerto Rico

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Martin, , Slovakia

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Nitra, , Slovakia

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Prešov, , Slovakia

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Ružomberok, , Slovakia

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Trenčín, , Slovakia

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Trnava, , Slovakia

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Palma de Mallorca, Balearic Islands, Spain

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Badalona, Barcelona, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Santander, Cantabria, Spain

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Santiago de Compostela, La Coruña, Spain

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Gijón, Principality of Asturias, Spain

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Santa Cruz de Tenerife, Tenerife, Spain

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Alzira, Valencia, Spain

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Ávila, , Spain

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Cadiz, , Spain

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Granada, , Spain

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Huelva, , Spain

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Jaén, , Spain

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Madrid, , Spain

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Murcia, , Spain

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Pontevedra, , Spain

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Bern, , Switzerland

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Lausanne, , Switzerland

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Lugano, , Switzerland

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Bristol, Avon, United Kingdom

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Exeter, Devon, United Kingdom

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Plymouth, Devon, United Kingdom

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Torquay, Devon, United Kingdom

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Salford, Greater Manchester, United Kingdom

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Basingstoke, Hampshire, United Kingdom

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Southampton, Hampshire, United Kingdom

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Leicester, Leicestershire, United Kingdom

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Edinburgh, Lothian Region, United Kingdom

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Liverpool, Merseyside, United Kingdom

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Norwich, Norfolk, United Kingdom

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Nottingham, Nottinghamshire, United Kingdom

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Glasgow, Strathclyde, United Kingdom

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Dundee, Tayside Region, United Kingdom

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Newcastle upon Tyne, Tyne & Wear, United Kingdom

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Birmingham, West Midlands, United Kingdom

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Leeds, West Yorkshire, United Kingdom

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Belfast, , United Kingdom

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Swansea, , United Kingdom

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Countries

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United States Argentina Australia Austria Canada Czechia Denmark France Germany Hungary Ireland Italy Netherlands New Zealand Norway Poland Portugal Puerto Rico Slovakia Spain Switzerland United Kingdom

References

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Pandey KS, Giles K, Balashov K, Macdonell R, Windsheimer J, Martinez M, Bozin I, Raynaud S, Scaramozza M, Mokliatchouk O, Sun Z, Belviso N, Sato Y, Lin X, Okai A. Long-Term Safety and Effectiveness of Dimethyl Fumarate in Patients with Multiple Sclerosis Treated in Routine Medical Practice: Final Analysis of the ESTEEM Study. Neurol Ther. 2025 Feb;14(1):243-260. doi: 10.1007/s40120-024-00680-z. Epub 2024 Dec 14.

Reference Type DERIVED
PMID: 39673658 (View on PubMed)

Mao-Draayer Y, Bar-Or A, Balashov K, Foley J, Smoot K, Longbrake EE, Robertson D, Mendoza JP, Lewin JB, Everage N, Bozin I, Lyons J, Mokliatchouk O, Bame E, Giuliani F. Real-World Safety and Effectiveness of Dimethyl Fumarate in Patients with MS: Results from the ESTEEM Phase 4 and PROCLAIM Phase 3 Studies with a Focus on Older Patients. Adv Ther. 2025 Jan;42(1):395-412. doi: 10.1007/s12325-024-03047-w. Epub 2024 Nov 21.

Reference Type DERIVED
PMID: 39570545 (View on PubMed)

Williams MJ, Amezcua L, Chinea A, Cohan S, Okai A, Okuda DT, Vargas W, Belviso N, Bozin I, Jiang X, Lewin JB, Lyons J, Shen C, England SM, Grimes N. Real-World Safety and Effectiveness After 5 Years of Dimethyl Fumarate Treatment in Black and Hispanic Patients with Multiple Sclerosis in ESTEEM. Neurol Ther. 2023 Oct;12(5):1669-1682. doi: 10.1007/s40120-023-00517-1. Epub 2023 Jun 24.

Reference Type DERIVED
PMID: 37354276 (View on PubMed)

Other Identifiers

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109MS401

Identifier Type: -

Identifier Source: org_study_id

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