19 Eligibility Criteria ......................................................................................................... 1 9 2.1.1 Inclusion Criteria ...................................................................................................... 19 2.1.2 Exclusion Criteria ..................................................................................................... 20 Screening Evaluations ................................................................................................... 21 2.2.1 Within 3 Months Prior to Part Two Registration ...................................................... 21 2.2.2 Within 4 Weeks Prior to Part Two Registration ....................................................... 21 2.2.3 Within 7 Days Prior to Part Two Registration .......................................................... 21 Registration and Treatment A ssignment Procedures .................................................... 22 2.3.1 Prior to Registration for this Protocol ....................................................................... 22 2.3.2 Registration Procedure .............................................................................................. 22 2.3.3 Treatment Assignment Procedures ........................................................................... 23 3 STUDY IMPLEMENTATION ...................................................................................... 23 Study Design ................................................................................................................. 2 3 3.1.1 Schema ...................................................................................................................... 23 3.1.2 Pre-Treatment Phase: Pe rformed on 03-C-0277 .......................................................