...................... 49 4.5 Treatment Assignment ................................ ................................ .............. 49 4.5.1 Identification of subjects ................................ ................................ ........... 49 4.5.2 Randomization ................................ ................................ ........................... 49 4.6 Study Endpoints ................................ ................................ ........................ 49 4.6.1 Efficacy endpoints ................................ ................................ ..................... 49 4.6.2 Safety and tolerability endpoints ................................ ............................... 50 4.6.3 Exploratory translational endpoints ................................ ........................... 51 4.7 Study Assessment Procedures ................................ ................................ ...52 4.7.1 Screening assessments ................................ ................................ ............... 52 4.7.2 HLA -A2 testing ................................ ................................