Women with a positive pregnancy test at enrollment or prior to administration of study medication. Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within the days prior to investigational product administration and a negative urine pregnancy test within the days prior to the first investigational product administration, or a negative serum pregnancy test within the days prior to the first investigational product administration Sex and reproductive status; a) women of childbearing potential (WOCBP) who are pregnant or breastfeeding; b) women with a positive pregnancy test at enrollment or prior to administration of study medication Women with a positive pregnancy test on enrollment or prior to investigational product administration Women with a positive pregnancy test on enrollment or prior to investigational product administration Women who are pregnant, which includes women with a positive pregnancy test at enrollment or prior to the administration of study medication, or breastfeeding are not allowed on study Women with a positive pregnancy test on enrollment or prior to investigational product administration Women who are pregnant or breast feeding; women with a positive pregnancy test on enrollment or prior to study drug administration Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast-feeding Women with a positive pregnancy test on enrollment or prior to investigational product administration Women with a positive pregnancy test at enrollment or prior to administration of study medication Women with a positive pregnancy test on enrollment or prior to investigational product administration Women with a positive pregnancy test on enrollment or before investigational product administration Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breastfeeding All WOCBP MUST have a negative pregnancy test within 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 Women with a positive pregnancy test on enrollment or prior to investigational product administration Administration of any blood product within months of enrollment