......................................................... 14 2.2.1 Within 3 Months Prior to Enrollment ............................ ........................................... 14 2.2.2 Within 4 Weeks Prior to Enrollment ........................................................................ 14 2.2.3 Within 7 Days Prior to Enrollment .............................. ............................................. 14 Registration Procedures ........................................ ........................................................ 15 2.3.1 Prior to Registrati on for this Protocol....................................................................... 15 2.3.2 Registration Procedure.............................................................................................. 15 Treatment Assignment Procedures ................................ ............................................... 15 2.4.1 Cohorts........................................................ .............................................................. 15 2.4.2 Arms.......................................................................................................................... 15 2.4.3 Randomization and Arm Assignment....................................................................... 15 3 STUDY IMPLEMENTATION.......................................... ............................................