- Childbearing potential is defined as any woman who has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally post-menopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months). The investigator or a designated associate is required to advise the patient how to achieve adequate birth control. Highly effective contraception is defined in the study as methods that achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable and implantable), intrauterine device (IUD), intrauterine hormone -releasing system (IUS), bilateral tubal occlusion, successfully vasectomised partner and sexual abstinence. In addition, the use of condoms by patients or their partners is required unless the woman has had a hysterectomy. Contraception will start 4 weeks before the start of therapy, will continue during therapy including dose interruptions and for 4 months after the last dose of any component of the treatment regimen.