Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

NCT ID: NCT01442194

Last Updated: 2022-01-14

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

3076 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-01

Study Completion Date

2020-07-10

Brief Summary

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The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.

Detailed Description

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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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Fingolimod

non-interventional

Fingolimod

Intervention Type DRUG

parallel cohort

non-interventional

other disease-modifying therapy

Intervention Type DRUG

Interventions

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other disease-modifying therapy

Intervention Type DRUG

Fingolimod

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients that as part of their routine clinical care and according to the locally approved label, are either;
* Starting fingolimod at time of study entry.
* Starting another approved DMT or started within maximum 6 months prior to study entry.
* Patients, or a able legal representative of the patient, who are willing to provide written informed consent.

Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort

Exclusion Criteria

* Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Cullman, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Sottsdale, Arizona, United States

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Tucson, Arizona, United States

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Bakersfield, California, United States

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Banning, California, United States

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Burbank, California, United States

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Fresno, California, United States

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Fullerton, California, United States

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Huntington Beach, California, United States

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Irvine, 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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Newport Beach, California, United States

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Oceanside, California, United States

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Placentia, California, United States

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Pomona, California, United States

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Redding, California, United States

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Santa Monica, California, United States

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Temecula, California, United States

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Aurora, Colorado, United States

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Basalt, 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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Louisville, Colorado, United States

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Parker, Colorado, United States

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Fairfield, Connecticut, United States

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Hartford, Connecticut, United States

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Waterbury, Connecticut, United States

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Dover, Delaware, United States

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Newark, 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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Bradenton, Florida, United States

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Clermont, Florida, United States

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Delray Beach, Florida, United States

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Doral, Florida, United States

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Hollywood, Florida, United States

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Jupiter, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Panama City, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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Wellington, Florida, United States

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West Palm Beach, Florida, United States

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Weston, Florida, 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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Macon, Georgia, United States

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Suwanee, Georgia, United States

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Arlington Heights, Illinois, United States

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Carbondale, Illinois, United States

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Flossmoor, Illinois, United States

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Marywood, Illinois, United States

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Peoria, Illinois, United States

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Anderson, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Lafayette, Indiana, United States

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Merrillville, Indiana, United States

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Des Moines, Iowa, United States

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Kansas City, Kansas, United States

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Lenexa, Kansas, United States

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Overland Park, Kansas, United States

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Topeka, Kansas, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Hammond, Louisiana, United States

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Auburn, Maine, United States

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Bangor, 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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Charlotte Hall, Maryland, United States

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Hagerstown, Maryland, United States

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Lutherville, Maryland, United States

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Waldorf, 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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Springfield, Massachusetts, United States

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Wellesley, Massachusetts, United States

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Worcester, Massachusetts, United States

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Caro, Michigan, United States

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Detroit, Michigan, United States

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Jackson, Michigan, United States

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Owosso, Michigan, United States

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Rochester Hills, Michigan, United States

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Southfield, Michigan, United States

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Traverse City, Michigan, United States

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Edina, Minnesota, United States

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Golden Valley, Minnesota, United States

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City of Saint Peters, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Great Falls, Montana, United States

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Hastings, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Lebanon, New Hampshire, United States

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Fair Lawn, New Jersey, United States

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Livingston, New Jersey, United States

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Somerset, 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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Amherst, New York, United States

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Brooklyn, New York, United States

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Cedarhurst, New York, United States

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Johnson City, New York, United States

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Kingston, New York, United States

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Lake Success, 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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Poughkeepsie, New York, United States

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Staten Island, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Asheville, North Carolina, United States

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Asheville, North Carolina, United States

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Chapel Hill, 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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Durham, North Carolina, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Sanford, North Carolina, United States

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Wilmington, North Carolina, United States

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Bismarck, North Dakota, United States

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Bellevue, Ohio, United States

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Centerville, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Springfield, Oregon, United States

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Greensburg, Pennsylvania, United States

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Meadowbrook, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Willow Grove, Pennsylvania, United States

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Beaufort, South Carolina, United States

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Camden, South Carolina, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Old Point Station, South Carolina, United States

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Spartanburg, South Carolina, United States

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Spartanburg, South Carolina, 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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Brownwood, 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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Houston, Texas, United States

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Kingwood, Texas, United States

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Mansfield, Texas, United States

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San Antonio, Texas, United States

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Stafford, Texas, United States

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Sugar Land, Texas, United States

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Provo, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Alexandria, Virginia, United States

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Arlington, Virginia, United States

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Charlottesville, Virginia, United States

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McLean, Virginia, United States

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Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Vienna, Virginia, United States

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Winchester, Virginia, United States

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Richland, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Wenatchee, Washington, United States

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Beckley, West Virginia, United States

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Huntington, West Virginia, United States

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Green Bay, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Monroe, Wisconsin, United States

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Neenah, Wisconsin, United States

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Wisconsin Rapids, Wisconsin, United States

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Casper, Wyoming, United States

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Jenin, Buenos Aires, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Buenos Aires, , Argentina

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Ciudad Autonoma de Bs As, , Argentina

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Córdoba, , Argentina

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Salta, , Argentina

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Kogarah, New South Wales, Australia

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Box Hill, Victoria, Australia

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Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Edmonton, Alberta, Canada

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Saint John, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Guelph, Ontario, Canada

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Kingston, Ontario, Canada

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Ottawa, Ontario, Canada

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Saint Catharine's, Ontario, Canada

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Chicoutimi, 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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Montreal, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Santiago, , Chile

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Culiacan, State of Mexico, Mexico

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Distrito Federal, , Mexico

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Guaynabo, , Puerto Rico

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San Juan, , Puerto Rico

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Countries

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United States Argentina Australia Canada Chile Mexico Puerto Rico

Related Links

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Other Identifiers

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CFTY720D2403

Identifier Type: -

Identifier Source: org_study_id

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