 - Female subjects of child-bearing potential, willing to use reliable contraception see Section 5.10 for the duration of the study, through to the 30 day safety follow up visit a female of child-bearing potential is defined as any female, regardless of her age with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. Females with oligomenorrhea or who are perimenopausal, and young females who have begun to menstruate are considered to be of child-bearing potential 