 - Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until 2 weeks after the last dose of study medication: a Vasectomy with documentation of azoospermia. The documentation on male sterility can come from the site personnels: review of subjects medical records, medical examination andor semen analysis, or medical history interview. B Male condom. The allowed method of contraception is only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception. 