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EDSS and relapse data depend on patient-provided information (whether that be by oral interview or by observation), all complicated by the "good day, bad day" [i.e. snapshot in time] factor. Some MS treatments went thru FDA approval trials pre-revision of the EDSS scale, used different inc...

FWIW: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-02-FDA-Errata.pdf MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE - FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH DATE: July 20, 2007 TO: Participants at the Joint meeting between the ...