................................ ........... 19 5.4. Analysis Variables ................................ ................................ ................................ .......................... 19 6. SAMPLE SIZE ................................ ................................ ................................ ................................ ............ 19 7. GENERAL CONSIDERATIONS ................................ ................................ ................................ ............... 20 7.1. Analysis Sets ................................ ................................ ................................ ................................ ... 20 7.1.1. Safety Set PoI ................................ ................................