- Male subjects willing to comply with the applicable contraceptive requirements of the protocol, e.g. must agree to refrain from fathering a child until after the safety follow up visit. Male subjects do not need to use contraception if their partner has been through the menopause, or has had a hysterectomy or bilateral oophorectomy. If a male subject's partner is of child bearing potential, male subjects must agree to use a barrier method (condom) as a method of birth control in addition to any contraceptive measures normally taken by his partner, until after the safety follow up visit.