About Clinical Research
Study #50523

• Male participants if not surgically sterilized, must agree to use adequate contraception and not donate sperm from admission to the clinical site until 90 days after the last dosing of study drug. Adequate contraception for the male subjects is defined below:
o Female partner of childbearing potential is using hormonal contraceptives, or an IUD combined with one of the below:
 A diaphragm
 A cervical cap
 A condom
o Condom
o Total abstinence, in accordance with the lifestyle of the subject, is also acceptable.
• Females of NON Childbearing Potential
o Hysterectomy
o Bilateral salpingectomy
o Bilateral Oophorectomy
o Bilateral tubal occlusion
o Bilateral tubal ligation
o Post-menopausal for 12 months
• Females of Childbearing Potential who have a fertile male sexual partner (ie. Not surgically sterilized for at least 6 months prior to screening) must agree to use adequate contraception from at least 4 weeks prior to administration of the study drug until 90 days after the last dosing of the drug. Adequate contraception is defined as
o Hormonal contraceptives or an IUD from at least 4 weeks prior to administration of study drug combined with at least 1 of the following forms of contraception from screening:
 A diaphragm
 A cervical cap
 A condom
o Total abstinence, in accordance with the lifestyle of the subject, is also acceptable (Note: Female subjects of childbearing potential who are in monogamous relationships with surgically sterilized male partners are not required to use additional contraception.)