Patients assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product Unwilling or unable to participate in all required study evaluations and procedures The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee Patients who are unwilling to be transfused with blood components Unwilling or unable to follow protocol requirements