.......... 25 8.2 Randomization, blinding and treatment allocation ................................ .................. 25 8.3 Study procedures ................................ ................................ ................................ ...25 8.4 Withdrawal of individual subjects ................................ ................................ ............ 27 8.4.1 Specific criteria for withdrawal (if applicable) ................................ ................... 27 8.5 Replacement of individual subjects after withdrawal ................................ ............... 28 8.6 Follow -up of subjects withdrawn from treatment ................................ ..................... 28 8.7 Premature termination of the study ................................ ................................ ......... 28 9. SAFETY REPORTING ................................ ................................