Common use of Males Clause in Contracts

Males. You must agree to the following during the study and for at least 90 days after the last dose of study drug: • Refrain from donating sperm • Be abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent 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 • Implantable progestogen-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • 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 and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the 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 methods) The effects of the study drug on the following are not known and may involve unforeseeable risks: • Fertility • Sperm • Pregnancy • Unborn child • Breastfeeding child Even if you use birth control during the study, there is a chance your partner could become pregnant. If your partner is pregnant or becomes 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. You cannot participate in this study if: • You are a man whose female partner is currently pregnant or planning to become pregnant If you want to stop your required birth control during the study, you should tell the study investigator

Males. You must agree to the following during the study and for at least 90 97 days after the last dose of study drug: • Refrain from donating sperm • Be abstinent from heterosexual or homosexual intercourse as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must agree to use birth control/barrier control as detailed below: • Agree to use a male condom and should also be advised when engaging in any activity that allows for passage of the benefit for a female partner ejaculate 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 • another person. In addition to male condom use, a if your female partner is able to have children, you agree not engage in sexual activity unless she is using an additional highly effective method of birth control may be considered in female partners able control. Low user dependency methods (methods that do not rely on you to have children of male participants remember to use them) • Implantable progestogen-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • 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 control *(See Note Belowbelow) o Oral* o Intravaginal* o Transdermal* o Injectable* • Sexual abstinence – - defined as refraining from heterosexual intercourse and is during the preferred and usual lifestyle entire period of risk associated with the participant study drug. *Note: One of the following barrier methods must be used in addition to the user dependent hormonal birth control methodsmethods detailed above: • 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 methods) The effects of the study drug on the following are not known and may involve unforeseeable risks: • Fertility • Sperm • Pregnancy • Unborn child • Breastfeeding child Even if you use birth control during the study, there is a chance your partner could become pregnant. If your partner is pregnant or becomes 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. You cannot participate in this study if: • You If you are a man whose female partner is currently pregnant or planning plan to become pregnant 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

Males. You must agree to the following during the study and for at least 90 days after the last dose of study drug: •  Refrain from donating sperm •  Be abstinent from heterosexual or homosexual intercourse as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent  Must agree to use birth control/barrier as detailed below: • Agree to use a male condom and when engaging in any activity that allows for passage of ejaculate to another person  Male participants 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 • pregnant.  Implantable progestogen-only hormone birth control •  Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) •  Bilateral tubal occlusion (both tubes blocked) which includes included 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 entire study period and is the preferred and usual lifestyle of the participant participant)  Hormonal birth control *(See Note Below) PLUS *Note: One of the following barrier methods must be used in addition to the 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 methodsmethod) The effects of the study drug on the following are not known and may involve unforeseeable risks: • Fertility •  Sperm •  Pregnancy •  Unborn child •  Breastfeeding child Even if you use birth control during the study, there is a chance that your partner could become pregnant. If your partner is pregnant or becomes pregnant during the study, the study drug or procedure procedures may involve unforeseeable risks to the unborn child. A pregnancy test is not always right, especially in the early stages of pregnancy. You cannot participate in this study if: •  You are currently pregnant, planning to become pregnant, or breastfeeding a child  You are a man whose female partner is currently pregnant or planning to become pregnant If you want to stop your required birth control during the study, you should tell the study investigator

Males. You must agree to the following during the study and No birth control methods are required for at least 90 days after the last dose of study drug: • Refrain from donating sperm • Be abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent Must agree male participants in this study. Your partner may choose to use birth control/barrier as detailed belowcontrol because of your participation in the study. If that is the case, the following methods may be used: • 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 Implantable progestogen-only hormone 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 • Implantable progestogen-only hormone birth control only) • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUSfemale partners able to have children of male participants only) • 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) control* • Sexual abstinence – - defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must may also be used in addition to the hormonal birth control methodscontrol: • 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 methods) The effects of the study drug on human reproduction are unknown. At this time, it is not known whether the study drug can cause harm to a human fetus, however, animal studies have not shown a harmful effect on fetal development. It is also not known whether the study drug can affect male or female fertility in humans, or whether the study drug is secreted in human milk. No adverse effects were observed on fertility or early embryonic development in male and female rats. The study drug should not be administered to pregnant women or women who are breastfeeding. An appropriate method of contraception is required for female participants. The effects of the study drug on the following are not known and may involve unforeseeable risks: • Fertility • Sperm • Pregnancy • Unborn child • Breastfeeding child Carbamazepine can cause harm to an unborn child when given to a pregnant woman. Even if you use birth control during the study, there is a chance your partner you could become pregnant. If your partner is you are pregnant or becomes become pregnant during the study, the study drug or procedure procedures may involve unforeseeable risks to the unborn child. A pregnancy test is not always right, especially in the early stages of pregnancy. You cannot participate in this study if: • You are a man whose female partner is currently pregnant or planning to become pregnant breastfeeding If you want to stop your required birth control during the study, you should tell the study investigator

Males. You must agree to the following during the study and for at least 90 28 days after the last dose of study drug: . • Refrain from donating sperm • 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 Must agree to use birth control/barrier control as detailed below: • Agree to use a male condom and should also be advised when engaging in any activity that allows for passage of the benefit for a female partner ejaculate 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 • another person. 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 • Implantable progestogen-only hormone may consider an additional highly effective birth control method such as the methods detailed earlier in this document and the following: • Intrauterine device Combined (IUDestrogen and progestogen containing) hormonal contraception o Oral o Intravaginal o Transdermal o Injectable • Intrauterine hormone-releasing system (IUS) Progestogen containing hormonal contraception o Oral o Injectable • 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 Be abstinent from heterosexual intercourse and is the as your preferred and usual lifestyle of (abstinent on a long- term and persistent basis) and agree to remain abstinent during the participant entire risk period *Note: One For female partners able to have children, one of the following barrier methods must be used in addition to the hormonal user dependent birth control methodsmethods detailed above: • 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 methods) The effects of the study drug on the following are not known and may involve unforeseeable risks: • Fertility • Sperm • Pregnancy • Unborn child • Breastfeeding child The effects of the study drug on reproduction are unknown. At this time, it is not known whether the study drug can cause harm to the fetus or whether it is secreted in human milk. Therefore, the study drug should not be administered to pregnant women or women who are breastfeeding. An appropriate method of contraception is required. 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 is are pregnant or becomes pregnant 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. You canIf you are currently pregnant, plan to become pregnant, or are breastfeeding a child, you should not participate in join this study if: • You study. If you are a man whose female partner is currently pregnant or planning plan to become pregnant 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

Males. You must agree to the following during the study and for at least 90 28 days after the last dose of study drug: • Refrain from donating sperm • Be abstinent from heterosexual intercourse as your preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent 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 • Implantable progestogen-only hormone birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • 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) control • Sexual abstinence – defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the 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 methods) The effects of the study drug on the following are not known and may involve unforeseeable risks: • Fertility • Sperm • Pregnancy • Unborn child • Breastfeeding child Even if you use birth control during the study, there is a chance your partner could become pregnant. If your partner is pregnant or becomes 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. You cannot participate in this study if: • You are a man whose female partner is currently pregnant or planning to become pregnant If you want to stop your required birth control during the study, you should tell the study investigator

Males. You must agree to the following during the study and for at least 90 28 days after the last dose of study drug: • Refrain from donating sperm • 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 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 below. • Implantable progestogen-only hormone hormonal birth control • Intrauterine device (IUD) • Intrauterine hormone-releasing system (IUS) • 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 control (*See Note Below) • Sexual abstinence – defined as refraining from heterosexual intercourse and is the preferred and usual lifestyle of the participant *Note: One of the following barrier methods must be used in addition to the 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-barrier methodsmethod) The effects of the study drug on the following are not known and may involve unforeseeable risks: • Fertility • Sperm • Pregnancy • Unborn child • Breastfeeding child Even if you use birth control during the study, there is a chance that your partner could become pregnant. If your partner is pregnant or becomes pregnant during the study, the study drug or procedure procedures may involve unforeseeable risks to the unborn child. A pregnancy test is not always right, especially in the early stages of pregnancy. You cannot participate in this study if: • You are a man whose female partner is currently pregnant or planning to become pregnant If you want to stop your required birth control during the study, you should tell the study investigator