........ 25 2.1.2 Exclusion Criteria ................................ ................................ ................................ .......26 2.1.3 Recruitment Strategies ................................ ................................ ................................ 28 2.2 SCREENING EVALUATION ................................ ................................ ................................ ...28 2.3 REGISTRATION PROCEDURES ................................ ................................ .............................. 28 2.3.1 Treatment Assignment Procedure ................................ ................................