18 6.4 Medical History .............................................................................................................. 18 6.5 Prior and Concurrent Medications .................................................................................... 18 7 Efficacy Analyses ................................................................................................................... 18 7.1 Primary Efficacy Analysis ................................................................................................ 19 7.2 Secondary Efficacy Analyses .......................................................................................... 19 7.3 Exploratory Analyses ...................................................................................................... 20 8 Safety Analyses ..................................................................................................................... 21 8.1 Extent of Exposure ........................................................................................................ 21 8.2 Adverse Events ............................................................................................................. 21 8.3 Serious Adverse Events, Premature Treatment Discontinuation and Deaths .......................... 22 8.4 Clinical Laboratory Evaluations ........................................................................................ 22 8.5 Other Safety Measures ................................................................................................... 23 Appendix 1: List of Planned Figures and Tables .................................................................................... 23 9 References ............................................................................................................................