 - Are women breastfeeding or pregnant, or intend to become pregnant during the course of the study; are men who intend to impregnate their partners; or are sexually active of procreation potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. Are investigator site personnel directly affiliated with this study andor their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 