10. Women of child bearing potential should be using an effective method of contraception (complete abstinence, any intrauterine device (IUD) with published data showing that the lowest expected failure rate is < 1 % per year; or any other methods with published data showing that the lowest expected failure rate is less than 1 % per year) before entry into the study and throughout the same and for 6 months after ending the study. Women of childbearing potential must have a negative test serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of beta human chorionic gonadotropin [β-HCG]) within 7 days prior to randomization.