 7. Subjects must be willing to comply with all aspects of the clinical trial protocol, including blood sampling, for the whole duration of the study Women of child-bearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilisation hysterectomy, bilateral tubal ligation or bilateral oophorectomy or is not postmenopausal post-menopausal is defined as amenorrhea for 12 consecutive months or women on hormone replacement therapy with documented serum follicle stimulating hormone level 35 mIUmL. Even in women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods diaphragm, condoms, spermicides to prevent pregnancy or practicing abstinence or where partner is sterile, e.g. vasectomy, should be considered to be of child bearing potential 