 An interim safety analysis Interim Analysis 1 will be conducted after the first 21 patients in the investigational therapy arm, and a total of 42 subjects in both arms, have completed the 90 day toxicity assessment following randomization phase 2 component. If, at this point, there are no safety concerns as determined by the Data and Safety Monitoring Board DSMB, the trial will continue as a phase 3 study with two additional interim analyses Interim Analyses 2 3. The primary analysis for treatment efficacy will be based on all randomized subjects. 