........................... 26 5.8 WOCBP, Contraception, Use in Pregnancy, Use in Nursing ................................ 28 5.9 Duration of Therapy ................................ ................................ ............................... 30 5.10 Criteria for Removal from Treatment ................................ ................................ .... 30 5.11 End of Treatment (EOT) Visit ................................ ................................ ............... 34 5.12 Duration of Follow - Up ................................ ................................ .......................... 34 5.13 34 6. DOSING DELAYS/DOSE MODIFICATIONS ................................ ............................... 35 6.1 Dose Modifications ................................ ................................ ................................ 35 6.2 Dosin g Delays ................................ ................................