............................. 20 5.2 Definition of Dose Limiting Toxicity: N/A ................................ ........................... 22 5.3 General Concomitant Medication and Supportive Care Guidelines ...................... 22 5.4 Duration of Therapy ................................ ................................ ............................... 23 5.5 Duration of Follow Up ................................ ................................ ........................... 23 5.6 Criteria for Removal from Study ................................ ................................ ........... 23 5.7 Laboratory Specimen collection ................................ ................................