Abstract

n engl j med 366;26 nejm.org june 28, 2012 2528 formed of the available treatments for multiple sclerosis. They were also reminded of the available treatments and of their right to leave the study during the trial if a relapse or progression of their disability was diagnosed, and they were required to sign a second consent form at this time. Because we instituted these measures, which were reviewed and approved by every ethics committee and competent health authority involved in the study, we are confident that patients were fully aware of the currently available treatment options. Furthermore, it should be considered that many patients were needle-phobic and tended to reject injection therapies, which were the only first-line therapies available at the time the study began. Approximately 38% of the patients in the laquinimod group and 40% of those in the placebo group had received treatments for multiple sclerosis before the study began, and these patients consented to participation.

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