The sample size has now been set at 446 evaluable patients (previously 650), of which 176 patients randomized after the protocol change will be considered for determination of the primary end point of 28- day mortality, as recommended by the FDA. The trial remains powered at 80 percent and the alpha remains at < 0.05 for its primary end point. The methodology for the sample size recalculation was presented to the DSMB at its quarterly meeting on September 3, 2015 and was accepted without further comment or the need for an interim analysis for this purpose, as had been previously contemplated. The Company submitted its revised statistical analysis plan to the FDA and it was accepted.