Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to study registration; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
Women of childbearing potential must have a negative serum or urine pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women who are pregnant or breast-feeding, or intend to become pregnant during the study; women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
A negative serum or urine pregnancy test must be done within  hours before the first dose of the study medication for women of childbearing potential as per institutional guidelines; post-menopausal women (defines as no menses for at least  year) and surgically sterilized women are not required to undergo pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgement of the investigator
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
-Pregnant or lactating women.  Women of childbearing potential must have a negative\n             pregnancy test.  Pregnancy testing is not required for post-menopausal or surgically\n             sterilized women.
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug. Post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator.
Women of childbearing potential must have a negative serum pregnancy test performed within  weeks prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Negative serum pregnancy test done =<  days prior to randomization, for women of childbearing potential only; note: post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator
Women who are pregnant or breast-feeding; women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  weeks prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum or urine pregnancy test performed within  days prior to the start of study drug. Post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test.
The patient is a woman who is pregnant or lactating; women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test; all patients (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least  days after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug. Post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test.
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as age >=  years and no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test
Women of childbearing potential must have a negative serum pregnancy test performed within  days prior to the start of study drug; post-menopausal women (defined as no menses for at least  year) and surgically sterilized women are not required to undergo a pregnancy test; the definition of adequate contraception will be based on the judgment of the investigator