 b. Either practice true abstinence from heterosexual contact which must be reviewed on a monthly basis and source documented or agree to use, and be able to comply with, effective contraception without interruption eg, oral, inject able, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; true abstinence; or vasectomized partner, 28 days prior to starting study treatment, during the study therapy including dose interruptions, and for at least 90 days after discontinuation of study treatment. 