Common use of Females able to have children Clause in Contracts

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drug. Please note that ritonavir can make estradiol-containing birth control less effective. A barrier method or other nonhormonal method of birth control must also be used if you are using estradiol-containing birth control. Highly effective methods of birth control include: • Implantable progestogen-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Hormonal birth control* (See Note below) • Sexual abstinence – defined as refraining from heterosexual intercourse during the study and for 28 days after the last dose of study drug, and is the preferred and usual lifestyle of the participant PLUS *Note: One of the following barrier methods must be used in addition to the use of hormonal birth control methods: • Male or female condom with or without spermicide • Cervical cap, diaphragm, or sponge with spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double barrier method) Males You must agree to the following during the study and for at least 28 days after the last dose of study drug: • Refrain from donating sperm PLUS either • Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Must agree to use birth control/barrier as detailed below: • Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of birth control as a condom may break or leak when having sexual intercourse with a female able to have children who is not currently pregnant • In addition to male condom use, a highly effective method of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document Pregnancy-Related Risks The effects of the study drug taken with ritonavir on the following are not known and may involve unforeseeable risks: • Fertility • Pregnancy • Unborn child • Breastfeeding child The study drug taken with ritonavir has not been studied in pregnant or lactating women. It is unknown if it can cause harm to an unborn child or if it is secreted in human milk. Animal studies with the study drug have not shown a harmful effect on fetal (unborn) development. Animal studies with ritonavir have shown a harmful effect on reproduction. In a large study of pregnant women who received ritonavir during pregnancy, there was no increase in birth defects. Therefore, until more is known about the study drug, if you are pregnant, planning to become pregnant during the study, or breastfeeding a child, you should not take part in this study. An appropriate method of birth control is required. Even if you use birth control during the study, there is a chance you or your partner could become pregnant. If you or your partner are pregnant or become pregnant during the study, the study drug or procedure may involve unforeseeable risks to the unborn child. A pregnancy test is not always right, especially in the early stages of pregnancy. If you are a man whose partner is currently pregnant or plan to father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator immediately. You will be taken out of the study if you stop using birth control or you become pregnant.

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drug. Please note that ritonavir carbamazepine can make estradiol-containing birth control hormonal contraceptives less effective. A barrier method or other nonhormonal It is suggested that a back-up method of birth control be utilized, such as a condom. You must also be used if you are using estradiol-containing birth controlnot donate eggs for the purpose of reproduction for the duration of the study and for at least 28 days after the last dose of study drug. Highly effective methods of birth control include: Low user dependency methods (methods that do not rely on you to remember to use them) • Implantable progestogen-only hormone birth control • Copper Intrauterine device (IUD) • Intrauterine hormone-releasing system • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Hormonal birth control* User dependent methods (See Note belowmethods that rely on you to remember to use them) • Sexual abstinence – defined as refraining from heterosexual intercourse during the study and for 28 days after the last dose of study drug, and is the preferred and usual lifestyle of the participant PLUS *Note: One of the following barrier methods must be used in addition to the use of hormonal birth control methods: • Male or female condom with or without spermicide • Cervical cap, diaphragm, or sponge with spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double barrier method) Males You must agree to the following during the study and for at least 28 days after the last dose of study drug: . • Refrain from donating sperm PLUS either • Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Must agree to use birth control/barrier as detailed below: • Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of birth control as a condom may break or leak when having sexual intercourse with a female able to have children who is not currently pregnant • In addition to male condom use, a highly effective method of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document Pregnancy-Related Risks The effects of the study drug taken with ritonavir on the following are not known and may involve unforeseeable risks: • Fertility Sperm • Pregnancy • Unborn child • Breastfeeding child The effects of the study drug taken with ritonavir has on reproduction are unknown. At this time, it is not been studied in pregnant or lactating women. It is unknown if it known whether the study drug can cause harm to an unborn child the fetus or if whether it is secreted in human milk. Animal studies with Therefore, the study drug have should not shown a harmful effect on fetal (unborn) development. Animal studies with ritonavir have shown a harmful effect on reproduction. In a large study of be administered to pregnant women or women who received ritonavir during pregnancy, there was no increase in birth defects. Therefore, until more is known about the study drug, if you are pregnant, planning to become pregnant during the study, or breastfeeding a child, you should not take part in this studybreastfeeding. An appropriate method of birth control is required. Carbamazepine can cause harm to an unborn child. Even if you use birth control during the study, there is a chance you or your partner partner, could become pregnant. If you or your partner are pregnant or become pregnant pregnant, during the study, the study drug drugs or procedure may involve unforeseeable risks to the unborn child. A \A pregnancy test is not always right, especially in the early stages of pregnancy. If you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you should not join this study. If you are a man whose partner is currently pregnant or plan to father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator immediately. You will might be taken out of the study if you stop using birth control or you become pregnant.

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drug. Please note that ritonavir can make estradiol-containing birth control less effective. A barrier method or other nonhormonal method of birth control must also be used if you are using estradiol-containing birth controldosing. Highly effective methods of birth control include: • Implantable progestogen-only hormone hormonal birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system • Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) • Partner has a vasectomy (absence of sperm confirmed) • Hormonal birth control* control (*See Note belowBelow) • Sexual abstinence – defined as refraining from heterosexual intercourse during the study and for 28 days after the last dose of study drug, and is the preferred and usual lifestyle of the participant PLUS *Note: One of the following barrier methods must be used in addition to the use of hormonal birth control methods: • Male or of female condom with or without spermicide • Cervical cap, diaphragm, or sponge with or without spermicide • A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double double-barrier method) Males You must agree to the following during the study and for at least 28 days after the last dose of study drug: • Refrain from donating sperm PLUS either • Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Must agree to use birth control/barrier as detailed below: • Agree Must agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of birth control as a condom may break or leak when having sexual intercourse with a female woman who is able to have children who is not currently pregnant • In addition to male condom use, a female partners able to have children may consider an additional highly effective method of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document Pregnancy-Related Risks The effects of the study drug taken with ritonavir on the following are not known and may involve unforeseeable risks: • Fertility • Pregnancy • Unborn child • Breastfeeding child The study drug taken with ritonavir has not been studied in pregnant or lactating women. It is unknown if it can cause harm to an unborn child or if it is secreted in human milk. Animal studies with the study drug have not shown a harmful effect on fetal (unborn) development. Animal studies with ritonavir have shown a harmful effect on reproduction. In a large study of pregnant women who received ritonavir during pregnancy, there was no increase in birth defects. Therefore, until more is known about the study drug, if you are pregnant, planning to become pregnant during the study, or breastfeeding a child, you should not take part in this study. An appropriate method of birth control is required. Even if you use birth control during the study, there is a chance you or your partner could become pregnant. If you or your partner are pregnant or become pregnant during the study, the study drug or procedure may involve unforeseeable risks to the unborn child. A pregnancy test is not always right, especially in the early stages of pregnancy. If you are a man whose partner is currently pregnant or plan to father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator immediately. You will be taken out of the study if you stop using birth control or you become pregnantabove.

Females able to have children. If you are sexually active, you must use a highly effective method of birth control. The birth control must be used consistently and correctly from the start of dosing (earlier for hormonal birth control), during the study, and for at least 28 days after the last dose of study drug. Please note that ritonavir can make estradiol-containing birth control less effective. A barrier method or other nonhormonal method of birth control must also be used if you are using estradiol-containing birth control. Highly effective methods of birth control include: •  Implantable progestogen-only hormone birth control •  Intrauterine device (IUD) •  Intrauterine hormone-releasing system •  Bilateral tubal occlusion (both tubes blocked) which includes bilateral tubal ligation (both tubes tied) •  Partner has a vasectomy (absence of sperm confirmed) •  Hormonal birth control* (See Note below) •  Sexual abstinence – defined as refraining from heterosexual intercourse during the study and for 28 days after the last dose of study drug, and is the preferred and usual lifestyle of the participant PLUS *Note: One of the following barrier methods must be used in addition to the use of hormonal birth control methods: •  Male or female condom with or without spermicide •  Cervical cap, diaphragm, or sponge with spermicide •  A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double barrier method) Males You must agree to the following during the study and for at least 28 days after the last dose of study drug: •  Refrain from donating sperm PLUS either •  Be abstinent from heterosexual intercourse with a female able to have children as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Must agree to use birth control/barrier as detailed below: •  Agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of birth control as a condom may break or leak when having sexual intercourse with a female able to have children who is not currently pregnant •  In addition to male condom use, a highly effective method of birth control may be considered in female partners able to have children of male participants such as the methods detailed earlier in this document Pregnancy-Related Risks The effects of the study drug taken with ritonavir on the following are not known and may involve unforeseeable risks: •  Fertility •  Pregnancy •  Unborn child •  Breastfeeding child The study drug taken with ritonavir has not been studied in pregnant or lactating women. It is unknown if it can cause harm to an unborn child or if it is secreted in human milk. Animal studies with the study drug have not shown a harmful effect on fetal (unborn) development. Animal studies with ritonavir have shown a harmful effect on reproduction. In a large study of pregnant women who received ritonavir during pregnancy, there was no increase in birth defects. Therefore, until more is known about the study drug, if you are pregnant, planning to become pregnant during the study, or breastfeeding a child, you should not take part in this study. An appropriate method of birth control is required. Even if you use birth control during the study, there is a chance you or your partner could become pregnant. If you or your partner are pregnant or become pregnant during the study, the study drug or procedure may involve unforeseeable risks to the unborn child. A pregnancy test is not always right, especially in the early stages of pregnancy. If you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you should not join this study. If you are a man whose partner is currently pregnant or plan to father a child, you cannot join this study. If you want to stop your required birth control during the study, you should tell the study investigator immediately. You will be taken out of the study if you stop using birth control or you become pregnant.