A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis
NCT ID: NCT01216072
Last Updated: 2014-02-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1053 participants
INTERVENTIONAL
2010-08-31
2012-08-31
Brief Summary
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This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fingolimod
Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period .
Fingolimod
0.5 mg/day oral capsule
Multiple Sclerosis Disease Modifying Treatments (MS DMTs)
Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Standard MS DMTs
Interventions
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Fingolimod
0.5 mg/day oral capsule
Standard MS DMTs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Expanded Disability Status Scale (EDSS) 0-5.5
* Continuous treatment with MS DMT for a minimum of 6 months
* Fingolimod naive
Exclusion Criteria
* Active macular edema
* History of selected prior infections and criteria for immunizations
* History of selected immune system treatments and/or medications
* Selected cardiovascular, pulmonary, or hepatic conditions
* Selected abnormal laboratory values
* Pregnant or nursing women
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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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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Cullman, Alabama, 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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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Berkeley, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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La Habra, California, United States
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Loma Linda, California, United States
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Newport Beach, California, United States
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Oceanside, California, United States
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Sacramento, California, United States
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Walnut Creek, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Fort Collins, Colorado, United States
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Fairfield, Connecticut, United States
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New London, Connecticut, United States
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Stratford, Connecticut, United States
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Dover, Delaware, United States
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Newark, Delaware, United States
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Atlantis, Florida, United States
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Bradenton, Florida, United States
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Doral, Florida, United States
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Fort Lauderdale, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, 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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Miami, Florida, United States
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Pompano Beach, Florida, United States
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Ponte Vedra Beach, Florida, United States
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Port Orange, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Sunrise, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Decatur, Georgia, United States
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Idaho Falls, Idaho, United States
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Elk Grove Village, Illinois, United States
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Evanston, Illinois, United States
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Flossmoor, Illinois, United States
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Northbrook, 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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Merrillville, Indiana, United States
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Valparaiso, Indiana, United States
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Des Moines, Iowa, United States
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Lenexa, Kansas, United States
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Baton Rouge, Louisiana, United States
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Destrehan, Louisiana, United States
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Hammond, Louisiana, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Worcester, Massachusetts, United States
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Detroit, Michigan, United States
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Grand Rapids, Michigan, United States
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Kalamazoo, Michigan, United States
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Southfield, Michigan, United States
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Bolivar, Missouri, United States
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Kansas City, Missouri, United States
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Kansas City, Missouri, United States
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Nixa, Missouri, United States
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North Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Freehold, New Jersey, United States
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Somerset, New Jersey, United States
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Teaneck, New Jersey, United States
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Toms River, New Jersey, United States
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Amherst, New York, United States
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Latham, 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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Asheville, North Carolina, United States
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Burlington, 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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Greenville, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Bellevue, Ohio, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Uniontown, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Corvallis, Oregon, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Monroeville, Pennsylvania, United States
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Rumford, Rhode Island, United States
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Beufort, South Carolina, United States
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Columbia, Tennessee, United States
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Cordova, Tennessee, United States
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Knoxville, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Colleyville, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Plano, Texas, United States
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Round Rock, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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Salt Lake City, Utah, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Roanoke, Virginia, United States
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Vienna, Virginia, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Morgantown, West Virginia, United States
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Calgary, Alberta, Canada
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Nepean, Ontario, Canada
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Ottawa, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Guaynabo, , Puerto Rico
Countries
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References
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Hughes B, Cascione M, Freedman MS, Agius M, Kantor D, Gudesblatt M, Goldstick LP, Agashivala N, Schofield L, McCague K, Hashmonay R, Barbato L; EPOC study investigators. First-dose effects of fingolimod after switching from injectable therapies in the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord. 2014 Sep;3(5):620-8. doi: 10.1016/j.msard.2014.06.006. Epub 2014 Jul 3.
Fox E, Edwards K, Burch G, Wynn DR, LaGanke C, Crayton H, Hunter SF, Huffman C, Kim E, Pestreich L, McCague K, Barbato L; EPOC study investigators. Outcomes of switching directly to oral fingolimod from injectable therapies: Results of the randomized, open-label, multicenter, Evaluate Patient OutComes (EPOC) study in relapsing multiple sclerosis. Mult Scler Relat Disord. 2014 Sep;3(5):607-19. doi: 10.1016/j.msard.2014.06.005. Epub 2014 Jul 4.
Calkwood J, Cree B, Crayton H, Kantor D, Steingo B, Barbato L, Hashmonay R, Agashivala N, McCague K, Tenenbaum N, Edwards K. Impact of a switch to fingolimod versus staying on glatiramer acetate or beta interferons on patient- and physician-reported outcomes in relapsing multiple sclerosis: post hoc analyses of the EPOC trial. BMC Neurol. 2014 Nov 26;14:220. doi: 10.1186/s12883-014-0220-1.
Cascione M, Wynn D, Barbato LM, Pestreich L, Schofield L, McCague K. Randomized, open-label study to evaluate patient-reported outcomes with fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis: EPOC study rationale and design. J Med Econ. 2013 Jul;16(7):859-65. doi: 10.3111/13696998.2013.802239. Epub 2013 May 20.
Related Links
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Other Identifiers
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CFTY720DUS01
Identifier Type: -
Identifier Source: org_study_id
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