Patient disposition and datasets analysed
A total of 205 patients were screened and 10 patients were considered screening failures. All patients enrolled constituted the intention to treat population (ITT), (N = 195). A total of 31 withdrawals occurred over the trial, resulting in 164 patients completing the trial. The most common reasons were: adverse event, moved/long travel distance, informed consent withdrawn, antibodies against natalizumab and pregnancy/pregnancy wish (Fig. 1).
10.1371/journal.pone.0058643.g001 Figure 1  Flow diagram of the TYNERGY trial.
The CONSORT flow diagram model showing enrolment, follow-up, and data analysis was applied.

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