ABSTRACT
The purpose of this chapter is to provide details regarding statistical characteristics and plans for conducting statistical analyses of efficacy of a drug T in the prevention of acute kidney injury (AKI). Details of the trial, including the statistical analysis section, appear in the protocol [1]. The objective as stated in the protocol appears in Section 7.2. Efficacy data
to be collected in the trial and protocol schema appear in Section 7.3. Primary and secondary efficacy endpoints as functions of these data appear in Section 7.4. The objective, translated as statistical hypotheses, appears in Section 7.5. Protocol design features appear in Section 7.6. Details of planned statistical analyses are presented in Section 7.7, including identification of populations upon whom analyses of efficacy are performed.
