Female subject must either:
Female subject must either:
The subject is pregnant, as defined by a presumptive sign of pregnancy such as missed menses or a positive pregnancy test; NOTE: female subjects of childbearing potential are required to have a negative qualitative serum pregnancy test at the time of enrollment and within twenty-four (24) hours prior to the first dose of the investigational product\r\n* Female subject of childbearing potential is defined as follows:\r\n** Subject with regular menses\r\n** Subject with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Subject with history of tubal ligation\r\n* Female subject not of childbearing potential is defined as follows:\r\n** Subject who has undergone hysterectomy and/or bilateral oophorectomy\r\n** Subject who is post-menopausal, which is defined as amenorrhea for at least one (1) year in a female subject who is greater than forty-five (> 45) years old
Female subject not of childbearing potential is defined as follows:\r\n* Subject who has undergone hysterectomy and/or bilateral oophorectomy\r\n* Subject who is post-menopausal, which is defined as amenorrhea for at least one (1) year in a female subject who is greater than forty-five (> 45) years old
Female subject must either:
Note: Female subjects of childbearing potential are required to have a negative qualitative serum pregnancy test at the time of enrollment and within twenty-four (24) hours prior to the first dose of the investigational product\r\n* Female subject of childbearing potential is defined as follows:\r\n** Subject with regular menses\r\n** Subject with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding\r\n** Subject with history of tubal ligation\r\n* Female subject not of childbearing potential is defined as follows:\r\n** Subject who has undergone hysterectomy and/or bilateral oophorectomy\r\n** Subject who is post-menopausal, which is defined as amenorrhea for at least one (1) year in a female subject who is greater than forty-five (> 45) years old
Female subject must either:
Female subject must either:
Female subject must either:
Female subject is either:
One of the following is required: Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female subject or female partner of a male subject; Additional barrier method: contraceptive sponge or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female subject or female partner of a male subject. For male subject or male partner of female subject, vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy) performed at least 6 months before Screening. Tubal ligation in the female partner of a male subject performed at least 6 months before Screening. Established and ongoing use of oral, injected, or implanted hormonal contraceptive by female partner of a male subject.
If female, subject must be either:
Female subject must be either:
A female subject is eligible to enter the study if she is:
Female subject must either:
Female subject must either:
Female subject must either:
Female subject must either:
Female subject must be either:
A female subject is eligible to participate if she is of:
Female subject must either be:
Female subject must either: