 The duration of subject participation from signing the informed consent form will be up to 14 months includes screening period 1 Day, study IV drug administration approximately 2-14 Days, Standard of Care Oral Drug Administration 4-5 weeks the total maximum treatment period is typically 6 weeks, and a follow-up visit 12 months after the last dose of study drug. Baseline assessments for study eligibility will occur within 24 hours before the first dose of study drug. A minimum of 2 days 48 hours of study drug administration is required. 