Prior and concomitant therapies will also be presented in data listings. 8.3.8 Analysis of Other Safety Variables Analyses for other safety variables will be performed based on the nature of the parameters and assessment schedule as needed. A shift table for E COG comparing the worst post baseline to baseline will be presented by treatment arm and overall . 9 CHANGES FROM THE PRO TOCOL SPECIFIED STAT ISTICAL ANALYSES If discrepancies exist between the text of the statistical analysis as planned in the protocol, and the final SAP, a protocol amendment will not be issued and the SAP will prevail. 10 REFERENCES 1.