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Methods: A full trial protocol has been published2.
The trial protocol has been published previously.
The trial protocol has been published elsewhere [ 8].
The trial protocol has been registered at ClinicalTrials.gov (NCT 01085071).
The trial protocol has been described by Bower and colleagues.
The trial protocol has been previously published 14 and updated.
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In a press release, Bial stressed that the trial protocol had been approved by ANSM and that it had no reason to expect problems with the 50-milligram dose.
17 Details of this trial protocol have been published.
Details of the trial protocol have been published (www.isrctn.com; ISRCTN54195799) (13).
Modifications to the original trial protocol have been submitted as amendments to IRBs, and approval has been obtained.
Detailed descriptions of both the adaptation process from PALSA and the trial protocol have been previously published [ 7, 8].
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