No patients that are known to be pregnant or nursingXx_NEWLINE_xXNot pregnant or nursingXx_NEWLINE_xXNon-pregnant and non-nursing; women and men of reproductive potential should agree to use an effective means of birth controlXx_NEWLINE_xXSTEP I: The following patients will be excluded:* Pregnant women* Nursing womenXx_NEWLINE_xXSTEP II: The following patients will be excluded:* Pregnant women* Nursing womenXx_NEWLINE_xXPatients must not be pregnant or nursing* Note: Peri-menopausal women must be amenorrheic for > 12 months to be considered not of childbearing potentialXx_NEWLINE_xXPregnant women or nursing mothersXx_NEWLINE_xXStudy drug must not be administered to pregnant women or nursing mothersXx_NEWLINE_xXPregnant or nursing womenXx_NEWLINE_xXPregnant or nursing womenXx_NEWLINE_xXPregnancy or nursing or unwilling to take adequate birth control during therapyXx_NEWLINE_xXPregnant or nursing patientsXx_NEWLINE_xXNursing women who are unwilling to discontinue nursingXx_NEWLINE_xXPregnancy and/or nursing femalesXx_NEWLINE_xXPregnant or nursing female patients are excluded from this studyXx_NEWLINE_xX