Are surgically sterile, OR
Are surgically sterile, OR
If sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Be of non-childbearing potential: Clearly premenarchal or documented surgically sterile
Are surgically sterile, OR
documented surgically sterile
Negative serum pregnancy within 72 hours prior to receiving the first dose of study medication (unless surgically sterile or postmenopausal for greater than one year)
The patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Surgically sterile (bilateral tubal ligation, hysterectomy)
Are surgically sterile, or
Female patients must be at least 1 year postmenopausal or surgically sterile; or must agree to use a medically acceptable form of contraception
If sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Female patients who are post-menopausal or surgically sterile.
documented as surgically sterile (at least 1 month prior to Screening)
Patients, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)
Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)
For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after the treatment period
Are surgically sterile, OR
Are surgically sterile, or
Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)
Are surgically sterile, OR
documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
Are surgically sterile, OR
For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period
Were surgically sterile, OR
Are surgically sterile, OR
Are surgically sterile, OR
or, documented surgically sterile or status post hysterectomy
Surgically sterile OR
Are surgically sterile, OR
Are surgically sterile, OR
Females of childbearing potential must be surgically sterile, have a sterile male partner, be premenarchal or at least 2 years postmenopausal, practice abstinence or otherwise must use 2 effective methods of contraception from the time of initiation of investigational product.
Surgically sterile
Using adequate contraceptive measures, be surgically sterile or post-menopausal
Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening).
Are surgically sterile, or
Surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method.
They are using an effective method of contraception from screening to the end of the study, unless their sexual partner is surgically sterile
Surgically sterile (i.e., hysterectomy, tubal ligation, vasectomy).
Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)
Are surgically sterile, or