NCT02047097

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
5,487

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

Longer than P75 for all trials

Geographic Reach
21 countries

447 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

9 years

First QC Date

January 24, 2014

Last Update Submit

May 23, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • The number of participants that experience Adverse Events (AEs) that lead to discontinuation of dimethyl fumarate (DMF)

    Up to 5 years

  • The number of participants that experience Serious Adverse Events (SAEs)

    Up to 5 years

Secondary Outcomes (12)

  • Duration of dimethyl fumarate (DMF) use

    Up to 5 years

  • dimethyl fumarate (DMF) dosing frequency

    Up to 5 years

  • Primary reasons for discontinuation of dimethyl fumarate (DMF) use

    Up to 5 years

  • Frequency of relapses over time

    Up to 5 years

  • Disease progression as measured by Expanded Disability Status Scale (EDSS) over time

    Up to 5 years

  • +7 more secondary outcomes

Study Arms (1)

dimethyl fumarate (DMF)

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

Drug: dimethyl fumarate

Interventions

Provided under routine clinical care

Also known as: Tecfidera, DMF, BG00012
dimethyl fumarate (DMF)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing routine clinical care for Multiple Sclerosis.

You may qualify if:

  • \- 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (468)

Research Site

Birmingham, Alabama, 35209, United States

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Huntsville, Alabama, 35801, United States

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Gilbert, Arizona, 85234, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85018, United States

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Phoenix, Arizona, 85048, United States

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Scottsdale, Arizona, 85251, United States

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Tucson, Arizona, 85718, United States

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Fullerton, California, 92835, United States

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Hanford, California, 93230, United States

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Loma Linda, California, 92354, United States

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Los Angeles, California, 90015, United States

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Los Angeles, California, 90048, United States

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Newport Beach, California, 92663, United States

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San Francisco, California, 94158, United States

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Santa Ana, California, 92704, United States

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Aurora, Colorado, 80045, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80210, United States

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Fort Collins, Colorado, 80528, United States

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Danbury, Connecticut, 06810, United States

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Derby, Connecticut, 06418, United States

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Hartford, Connecticut, 06112, United States

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Norwich, Connecticut, 06360, United States

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Dover, Delaware, 19901, United States

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Wilmington, Delaware, 19801, United States

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Washington D.C., District of Columbia, 20007, United States

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Washington D.C., District of Columbia, 20037, United States

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Boca Raton, Florida, 33486, United States

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Gainesville, Florida, 32610, United States

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Jacksonville, Florida, 32216, United States

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Lighthouse PT, Florida, 33064, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33125, United States

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Port Charlotte, Florida, 33952, United States

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Sarasota, Florida, 34233, United States

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St. Petersburg, Florida, 33710, United States

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St. Petersburg, Florida, 33713, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30309, United States

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Atlanta, Georgia, 30327, United States

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Augusta, Georgia, 30912, United States

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Columbus, Georgia, 31909, United States

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Savannah, Georgia, 31406, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60637, United States

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Evanston, Illinois, 60201, United States

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Herrin, Illinois, 62948, United States

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Peoria, Illinois, 61603, United States

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Winfield, Illinois, 60190, United States

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Elkhart, Indiana, 46514, United States

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Indianapolis, Indiana, 46202, United States

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Des Moines, Iowa, 50309, United States

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Des Moines, Iowa, 50314, United States

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Waterloo, Iowa, 50702, United States

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Overland Park, Kansas, 66211, United States

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Overland Park, Kansas, 66212, United States

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Henderson, Kentucky, 42420, United States

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Louisville, Kentucky, 40207, United States

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Hammond, Louisiana, 70403, United States

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New Orleans, Louisiana, 70121, United States

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Rockport, Maine, 04856, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21287, United States

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Bethesda, Maryland, 20814, United States

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Cumberland, Maryland, 21502, United States

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Glen Burnie, Maryland, 21061, United States

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Boston, Massachusetts, 02111, United States

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Boston, Massachusetts, 02135, United States

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Foxborough, Massachusetts, 02035, United States

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Jamaica Plain, Massachusetts, 02130, United States

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Lexington, Massachusetts, 02421, United States

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Wellesley, Massachusetts, 02481, United States

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Worcester, Massachusetts, 01655, United States

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Ann Arbor, Michigan, 48109, United States

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East Lansing, Michigan, 48824, United States

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Farmington Hills, Michigan, 48334, United States

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West Bloomfield, Michigan, 48322, United States

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Edina, Minnesota, 55435, United States

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Minneapolis, Minnesota, 55407, United States

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Ocean Springs, Mississippi, 39564, United States

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Springfield, Missouri, 65806, United States

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St Louis, Missouri, 63110, United States

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Billings, Montana, 59101, United States

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Great Falls, Montana, 59405, United States

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Lincoln, Nebraska, 68506, United States

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Lincoln, Nebraska, 68521, United States

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Wahoo, Nebraska, 68066, United States

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Las Vegas, Nevada, 89106, United States

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Concord, New Hampshire, 03301, United States

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Audubon, New Jersey, 08106, United States

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Flemington, New Jersey, 08822, United States

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Hackensack, New Jersey, 07601, United States

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Livingston, New Jersey, 07039, United States

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New Brunswick, New Jersey, 08903, United States

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Newark, New Jersey, 07103, United States

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Stratford, New Jersey, 08084, United States

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Toms River, New Jersey, 08755, United States

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West Long Branch, New Jersey, 07764, United States

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Albany, New York, 12206, United States

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Cedarhurst, New York, 11516, United States

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East Meadow, New York, 11554, United States

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Kingston, New York, 12401, United States

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New York, New York, 10016, United States

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New York, New York, 10029, United States

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Patchogue, New York, 11772, United States

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Plainview, New York, 11803, United States

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Syracuse, New York, 13202, United States

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Syracuse, New York, 13210, United States

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Asheville, North Carolina, 28803, United States

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Charlotte, North Carolina, 28204, United States

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Charlotte, North Carolina, 28226, United States

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Greensboro, North Carolina, 27405, United States

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Hendersonville, North Carolina, 28792, United States

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Pinehurst, North Carolina, 28370, United States

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Raleigh, North Carolina, 27607, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27157, United States

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Bismarck, North Dakota, 58501, United States

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Canton, Ohio, 44735, United States

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Centerville, Ohio, 45459, United States

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Cincinnati, Ohio, 45267, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43210, United States

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Oklahoma City, Oklahoma, 73104, United States

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Tulsa, Oklahoma, 74136, United States

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Portland, Oregon, 97225, United States

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Portland, Oregon, 97239, United States

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Abington, Pennsylvania, 19001, United States

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Allentown, Pennsylvania, 18103, United States

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Greensburg, Pennsylvania, 15601, United States

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Meadowbrook, Pennsylvania, 19046, United States

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Monroeville, Pennsylvania, 15146, United States

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Natrona Heights, Pennsylvania, 15065, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15212, United States

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Columbia, South Carolina, 29203, United States

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Greenville, South Carolina, 29605, United States

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Spartanburg, South Carolina, 29307, United States

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Franklin, Tennessee, 37064, United States

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Knoxville, Tennessee, 37920, United States

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Knoxville, Tennessee, 37922, United States

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Nashville, Tennessee, 37205, United States

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Nashville, Tennessee, 37232, United States

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Arlington, Texas, 76012, United States

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Colleyville, Texas, 76034, United States

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Dallas, Texas, 75246, United States

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Dallas, Texas, 75390, United States

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Houston, Texas, 77030, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23298, United States

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Virginia Beach, Virginia, 23456, United States

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Kirkland, Washington, 98034, United States

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Seattle, Washington, 98101, United States

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Spokane, Washington, 99208, United States

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Tacoma, Washington, 98405, United States

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Tacoma, Washington, 98409, United States

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Green Bay, Wisconsin, 54301, United States

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Green Bay, Wisconsin, 54303, United States

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Green Bay, Wisconsin, 54308, United States

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Green Bay, Wisconsin, 54311, United States

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La Crosse, Wisconsin, 54601, United States

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Madison, Wisconsin, 53715, United States

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Milwaukee, Wisconsin, 53211, United States

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Milwaukee, Wisconsin, 53215, United States

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Neenah, Wisconsin, 54956, United States

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Waukesha, Wisconsin, 53188, United States

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Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1061ABD, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DKT, Argentina

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Vicente López, Buenos Aires, 1602, Argentina

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Rosario, Santa Fe Province, S2000DFD, Argentina

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Rosario, Santa Fe Province, S2000, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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Ciudad Autonoma Buenos Aires, 1199, Argentina

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Ciudad Autonoma Buenos Aires, C1013AAB, Argentina

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Ciudad Autonoma Buenos Aires, C1118AAT, Argentina

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Ciudad Autonoma Buenos Aires, C1192AAW, Argentina

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Córdoba, 5000, Argentina

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Córdoba, X5004CDT, Argentina

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Mendoza, M5502AWY, Argentina

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Salta, 4400, Argentina

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San Juan, 5400, Argentina

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Santiago del Estero, 4200, Argentina

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Villa Nueva, 5519, Argentina

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Camperdown, New South Wales, 2050, Australia

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Concord, New South Wales, 2139, Australia

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Kogarah, New South Wales, 2217, Australia

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Liverpool, New South Wales, 2170, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Randwick, New South Wales, 2031, Australia

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St Leonards, New South Wales, 2065, Australia

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Sydney, New South Wales, 2109, Australia

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Westmead, New South Wales, 2145, Australia

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Auchenflower, Queensland, 4066, Australia

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Gold Coast, Queensland, 9726, Australia

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Bedford Park, South Australia, 5042, Australia

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Kent Town, South Australia, 5067, Australia

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Box Hill, Victoria, 3128, Australia

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Clayton, Victoria, 3168, Australia

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Geelong, Victoria, 3220, Australia

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Heidelberg, Victoria, 3084, Australia

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Melbourne, Victoria, 3004, Australia

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Melbourne, Victoria, 3181, Australia

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Parkville, Victoria, 3050, Australia

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Nedlands, Western Australia, 6009, Australia

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Amstetten, 3300, Austria

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Salzburg, 5020, Austria

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Vienna, 1040, Austria

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Vienna, 1180, Austria

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Calgary, Alberta, T2N 2T9, Canada

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Burnaby, British Columbia, V5H 4K7, Canada

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Victoria, British Columbia, V8R 1J8, Canada

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Moncton, New Brunswick, E1C 6Z8, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Sydney, Nova Scotia, B1P 1P3, Canada

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Cambridge, Ontario, N1R7L6, Canada

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London, Ontario, N6A 5A5, Canada

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Milton, Ontario, L9T 5B5, Canada

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Scarborough Village, Ontario, M1R 3A6, Canada

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Thunder Bay, Ontario, P7B 6V4, Canada

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Gatineau, Quebec, J8Y 1W2, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H2L 4M1, Canada

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Montreal, Quebec, H3A 2B4, Canada

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Regina, Saskatchewan, S4S 3R8, Canada

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Brno, 656 91, Czechia

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Hradec Králové, 50333, Czechia

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Jihlava, 58633, Czechia

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Olomouc, 77520, Czechia

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Pardubice, 532 03, Czechia

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Prague, 100 34, Czechia

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Teplice, 41529, Czechia

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Aarhus C, 8200, Denmark

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Esbjerg, 6715, Denmark

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Glostrup Municipality, 2600, Denmark

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Odense C, 5000, Denmark

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Sønderborg, 6400, Denmark

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Montluçon, Allier, 03113, France

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Mulhouse, Haut Rhin, 68100, France

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Toulouse, Haute Garonne, 31059, France

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Pringy, Haute Savoie, 74374, France

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Rueil-Malmaison, Hauts De Seine, 92500, France

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Dax, Landes, 40107, France

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Agen, Lot Et Garonne, 47923, France

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Perpignan, Pyrenees Orientales, 66046, France

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Bron, Rhone, 69677, France

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La Roche-sur-Yon, Vendee, 85925, France

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Épinal, Vosges, 88021, France

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Gonesse, 95503, France

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Rambouillet, 78120, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Heidenheim, Baden-Wurttemberg, 89518, Germany

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Ladenburg, Baden-Wurttemberg, 68526, Germany

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Mannheim, Baden-Wurttemberg, 68159, Germany

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Mannheim, Baden-Wurttemberg, 68161, Germany

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Ravensburg, Baden-Wurttemberg, 88212, Germany

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Singen, Baden-Wurttemberg, 78224, Germany

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Sinsheim, Baden-Wurttemberg, 74889, Germany

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Stuttgart, Baden-Wurttemberg, 70176, Germany

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Stuttgart, Baden-Wurttemberg, 70178, Germany

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Stuttgart, Baden-Wurttemberg, 70182, Germany

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Ulm, Baden-Wurttemberg, 89078, Germany

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Alzenau in Unterfranken, Bavaria, 63755, Germany

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Bayreuth, Bavaria, 95445, Germany

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Bogen, Bavaria, 94327, Germany

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Erlangen, Bavaria, 91054, Germany

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Landshut, Bavaria, 84028, Germany

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Munich, Bavaria, 81825, Germany

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Neuburg am Inn, Bavaria, 86633, Germany

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Nuremberg, Bavaria, 90419, Germany

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Nuremberg, Bavaria, 90451, Germany

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Regensburg, Bavaria, 93095, Germany

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Unterhaching, Bavaria, 82008, Germany

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Wolfratshausen, Bavaria, 82515, Germany

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Würzburg, Bavaria, 97080, Germany

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Butzbach, Hesse, 35510, Germany

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Eltville, Hesse, 65343, Germany

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Erbach im Odenwald, Hesse, 64711, Germany

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Eschwege, Hesse, 37269, Germany

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Frankfurt am Main, Hesse, 60313, Germany

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Frankfurt am Main, Hesse, 60488, Germany

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Frankfurt am Main, Hesse, 60528, Germany

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Gelnhausen, Hesse, 63571, Germany

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Giessen, Hesse, 35392, Germany

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Gladenbach, Hesse, 35075, Germany

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Kassel, Hesse, 34121, Germany

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Wiesbaden, Hesse, 65183, Germany

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Buchholz, Lower Saxony, 21244, Germany

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Göttingen, Lower Saxony, 37073, Germany

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Oldenburg, Lower Saxony, 26122, Germany

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Stade, Lower Saxony, 21682, Germany

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Aachen, North Rhine-Westphalia, 52062, Germany

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Aachen, North Rhine-Westphalia, 52078, Germany

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Bad Honnef, North Rhine-Westphalia, 53604, Germany

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Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany

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Bielefeld, North Rhine-Westphalia, 33647, Germany

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Bochum, North Rhine-Westphalia, 44789, Germany

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Bonn, North Rhine-Westphalia, 53111, Germany

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Cologne, North Rhine-Westphalia, 50935, Germany

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Cologne, North Rhine-Westphalia, 51063, Germany

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Düsseldorf, North Rhine-Westphalia, 40211, Germany

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Essen, North Rhine-Westphalia, 45138, Germany

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Hagen, North Rhine-Westphalia, 58095, Germany

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Remscheid, North Rhine-Westphalia, 42853, Germany

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Siegen, North Rhine-Westphalia, 57076, Germany

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Willich, North Rhine-Westphalia, 47877, Germany

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Wuppertal, North Rhine-Westphalia, 42284, Germany

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Frankenthal, Rhineland-Palatinate, 67227, Germany

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Kandel, Rhineland-Palatinate, 76870, Germany

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Katzenelnbogen, Rhineland-Palatinate, 56368, Germany

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Rülzheim, Rhineland-Palatinate, 76761, Germany

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Trier, Rhineland-Palatinate, 54292, Germany

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Chemnitz, Saxony, 09117, Germany

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Görlitz, Saxony, 02828, Germany

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Leipzig, Saxony, 04103, Germany

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Leipzig, Saxony, 04229, Germany

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Wermsdorf, Saxony, 04779, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Eisenach, Thuringia, 99817, Germany

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Erfurt, Thuringia, 99096, Germany

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Jena, Thuringia, 07747, Germany

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Berlin, 10713, Germany

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Berlin, 10961, Germany

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Berlin, 12099, Germany

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Berlin, 12163, Germany

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Berlin, 13347, Germany

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Berlin, 13465, Germany

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Hamburg, 20249, Germany

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Hamburg, 21149, Germany

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Neusäß, 86356, Germany

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Budapest, 1086, Hungary

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Budapest, 1106, Hungary

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Budapest, 1145, Hungary

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Eger, 3300, Hungary

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Győr, 9024, Hungary

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Miskolc, 3526, Hungary

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Szeged, 6725, Hungary

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Tatabánya, 2800, Hungary

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Zalaegerszeg, 8900, Hungary

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Dublin, D04 N2E0, Ireland

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Dublin, D09 V2N0, Ireland

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Torrette, Ancona, 60126, Italy

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Montichiari, Brescia, 25018, Italy

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Pozzilli, Isernia, 86077, Italy

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Legnano, Milano, 20025, Italy

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Fidenza, Parma, 43036, Italy

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Orbassano, Torino, 10043, Italy

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Gallarate, Varese, 21013, Italy

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Bari, 70124, Italy

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Bergamo, 24127, Italy

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Bologna, 40139, Italy

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Cagliari, 09126, Italy

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Catanzaro, 88100, Italy

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Genova, 16132, Italy

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Messina, 98125, Italy

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Milan, 20132, Italy

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Modena, 41126, Italy

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Napoli, 80131, Italy

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Palermo, 90127, Italy

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Palermo, 90146, Italy

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Parma, 43126, Italy

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Pavia, 27100, Italy

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Perugia, 06156, Italy

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Pordenone, 33170, Italy

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Reggio Emilia, 42100, Italy

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Roma, 00152, Italy

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Roma, 00161, Italy

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Roma, 00168, Italy

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Roma, 00189, Italy

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Amsterdam, 1091 AC, Netherlands

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Arnhem, 6815 AD, Netherlands

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Breda, 4818 CK, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Geldrop, 5664 EH, Netherlands

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Geleen, 6162 BG, Netherlands

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Hoorn, 1624 NP, Netherlands

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Leeuwarden, 8934 AD, Netherlands

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Leiden, 2334 CK, Netherlands

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Nieuwegein, 3435 CM, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Tilburg, 5042 AD, Netherlands

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Venlo, 5912 BL, Netherlands

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Christchurch, 8011, New Zealand

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Dunedin, 9016, New Zealand

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Hamilton, 3200, New Zealand

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Bodø, 8005, Norway

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Namsos, 7801, Norway

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Ochojec, Katowice, 40-635, Poland

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Bialystok, 15-276, Poland

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Bydgoszcz, 85-681, Poland

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Gdansk, 80-803, Poland

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Gmina Końskie, 26-200, Poland

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Grudziądz, 86-300, Poland

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Głogów Małopolski, 36-060, Poland

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Katowice, 40-571, Poland

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Katowice, 40-752, Poland

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Konstancin-Jeziorna, 05-510, Poland

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Krakow, 31-503, Poland

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Krakow, 31-637, Poland

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Lublin, 20-954, Poland

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Olsztyn, 10-561, Poland

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Poznan, 60-355, Poland

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Warsaw, 02-091, Poland

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Warsaw, 02-957, Poland

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Warsaw, 04-749, Poland

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Zabrze, 41-800, Poland

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Amadora, 2720-276, Portugal

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Braga, 4710-243, Portugal

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Guimarães, 4835-044, Portugal

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Matosinhos Municipality, 4454-509, Portugal

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Penafiel, 4560-007, Portugal

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Santarém, 2005-177, Portugal

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Viana do Castelo, 4901-858, Portugal

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Vila Nova de Gaia, 4434-502, Portugal

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Guaynabo, 00968, Puerto Rico

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San Juan, 00921, Puerto Rico

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Banská Bystrica, 97517, Slovakia

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Bratislava, 82101, Slovakia

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Bratislava, 83101, Slovakia

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Martin, 03659, Slovakia

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Nitra, 95001, Slovakia

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Prešov, 08081, Slovakia

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Ružomberok, 03426, Slovakia

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Trenčín, 91101, Slovakia

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Trnava, 917 75, Slovakia

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Palma de Mallorca, Balearic Islands, 07010, Spain

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Badalona, Barcelona, 08916, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Santander, Cantabria, 38003, Spain

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Santiago de Compostela, La Coruña, 15706, Spain

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Gijón, Principality of Asturias, 33206, Spain

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Santa Cruz de Tenerife, Tenerife, 38010, Spain

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Alzira, Valencia, 46600, Spain

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Ávila, 05004, Spain

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Cadiz, 11009, Spain

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Granada, 18014, Spain

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Huelva, 21080, Spain

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Jaén, 23007, Spain

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Madrid, 28006, Spain

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Murcia, 30008, Spain

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Pontevedra, 36071, Spain

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Bern, 3010, Switzerland

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Lausanne, CH-1011, Switzerland

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Lugano, 6900, Switzerland

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Bristol, Avon, BS10 5NB, United Kingdom

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Exeter, Devon, EX2 5DW, United Kingdom

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Plymouth, Devon, PL6 8DH, United Kingdom

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Torquay, Devon, TQ2 7AA, United Kingdom

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Salford, Greater Manchester, M6 8HD, United Kingdom

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Basingstoke, Hampshire, RG24 9NA, United Kingdom

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Southampton, Hampshire, SO16 6YD, United Kingdom

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Leicester, Leicestershire, LE5 4PW, United Kingdom

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Edinburgh, Lothian Region, EH4 2XU, United Kingdom

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Liverpool, Merseyside, L9 7LJ, United Kingdom

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Norwich, Norfolk, NR4 7UY, United Kingdom

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Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

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Glasgow, Strathclyde, G51 4TF, United Kingdom

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Dundee, Tayside Region, DD1 9SY, United Kingdom

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Newcastle upon Tyne, Tyne & Wear, NE4 5PL, United Kingdom

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Birmingham, West Midlands, B15 2GB, United Kingdom

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Leeds, West Yorkshire, LS1 3EX, United Kingdom

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Belfast, BT16 0RH, United Kingdom

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Swansea, SA6 6NL, United Kingdom

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Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 28, 2014

Study Start

November 19, 2013

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

May 24, 2023

Record last verified: 2023-05

Locations