 15. All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study. In addition, all WOCBP will be instructed to contact the Investigator immediately if they suspect they might be pregnant e.g., missed or late menstrual period at any time during study participation. The PI will immediately notify BMS in the event of a confirmed pregnancy in a patient participating in the study. 