............................... 12 4.1. Study Objectives ................................ ................................ ................................ ............................. 12 4.1.1. Primary Objective(s) ................................ ................................ ................................ ..... 12 4.1.2. Secon dary Objectives ................................ ................................ ................................ .... 12 4.2. Efficacy Endpoints in step -2 ................................ ................................