 10. Women of child bearing potential WOCBP who are pregnant, breast feeding or unwilling to avoid pregnancy by the use of highly effective contraception 1 failure rate per year including oral and subcutaneous implantable hormonal contraceptives, condoms, diaphragm, or intra-uterine system IUS, during the period that the experimental drug is administered. Prospective WOCBP must have a negative pregnancy test point of care. 