date:Aug 28, 2012
on a statistical analysis. The Panel considered that on the basis available to the Panel, the statistical analysis was inappropriate for the study design.
For an intention-to-treat analysis, the NDA said it had not received any data that could sway its opinion during stop-the-clock procedures.
EFSA would like to clarify that in its stop the clock letter of 20 July 2011 EFSA requested the applicant to present a comprehensive analysis of the outcomes of this study, which would be considered to