 11. Ability to become pregnant or already pregnant or lactating. However, those female patients who have a negative serum or urine pregnancy test before enrolment and agree to use two highly effective forms of contraception oral, injected or implanted hormonal contraception and condom, have a intra-uterine device and condom, diaphragm with spermicidal gel and condom for four weeks before entering the trial, during the trial and for six months afterwards are considered eligible. 