5 2 GENERAL PRINCIPLE S ................................................................................................................. 5 3 STUDY OBJECTIVES AND DESIGN ............................................................................................. 5 3.1 Study Objectives ......................................................................................................................... 5 3.2 Study Design ............................................................................................................................... 6 3.3 Visit Structure .............................................................................................................................. 7 3.4 Sample Size ................................................................................................................................ 7 3.5 Changes from the Protocol Planned Analysis ............................................................................ 7 4 STUDY PATIENTS ......................................................................................................................... 8 4.1 Analysis Sets .............................................................................................................................. 8 4.2 Disposition of Patients ................................................................................................................ 8 4.3 Eligibility ...................................................................................................................................... 8 4.4 Protocol Deviations ..................................................................................................................... 8 4.5 Demographic and other Baseline Characteristics ......................................................................