........ 46 6.4 Blinding and Minimization of Bias ................................ ................................ ............................. 46 7.0 SUBJECT COMPLETION AND WITHDRAWAL ................................ ................................ .......47 7.1 Subject Completion ................................ ................................ ................................ ..................... 47 7.2 Subject Withdrawal from Study ................................ ................................ ................................ ..47 7.2.1 Discontinuation from Study Treatment ................................ ................................ ............... 47 7.2.2 Discontinuation from Study Follow -Up ................................ ................................ .............. 48 7.2.3 Lost to Follow -Up ................................ ................................