............................... 37 3 ETHICAL CONSIDERATIONS ................................ ................................ ................ 38 3.1 Ethics and Good Clinical Practice ................................ ............................. 38 3.2 Ethics Committee/ Institutional Review Board ................................ ......... 39 3.3 Informed consent and subject information ................................ ................ 39 3.4 Governance of the study ................................ ................................ ............ 39 4 INVESTIGATIONAL PLAN ................................ ................................ ..................... 39 4.1 Overall Study Design and Plan ................................ ................................ .39 4.2 Study Population ................................ ................................ ....................... 41 4.2.1 Subject population ................................ ................................ ..................... 41 4.2.2 Inclusion criteria ................................ ................................ ........................ 41 4.2.3 Exclusion criteria ................................ ................................