Males or females of reproductive potential may not participate unless they have agreed to practice  highly effective and  additional effective (barrier) method of contraception at the same time during the entire study treatment period and through  months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception
Women of childbearing age should avoid becoming pregnant while taking any mTOR inhibitor including MLN (TAK-)\r\n*Female patients must:\r\n** Be postmenopausal for at least  year before the screening visit, OR\r\n** Be surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice  highly effective method of contraception and  additional effective (barrier) method, at the same time, from the time of signing the informed consent through  days (or longer, as mandated by local labeling [e.g., United States product insert [USPI], summary of product characteristics [SmPC], etc.;]) after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Male patients, even if surgically sterilized (i.e., status postvasectomy), must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug, OR \r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (NOTE: periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** AND agree not to donate sperm during the course of this study or within  days after receiving their last dose of study drug
Female patients who:\r\n* Are postmenopausal for at least  year before the screening visit\r\n* Are surgically sterile\r\n* If they are of childbearing potential, agree to practice  effective method of contraception and  additional effective (barrier) method, at the same time, from the time of signing the informed consent through  days (or longer as mandated by local labeling [e.g., United States product insert (USPI), summary of product characteristics (SmPC), etc,]) after the last dose of study drug\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n* Agree not to donate sperm during the course of this study or within  days after receiving their last dose of study drug
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condom should not be used together).
Female patients who: Are postmenopausal for at least  year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice  effective method of contraception and  additional effective (barrier) method, at the same time, from the time of signing the informed consent through  days (or longer as mandated by local labeling [e.g., United Surgical Partners International (USPI), summary of product characteristics (SmPC), etc,]) after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Agree not to donate sperm during the course of this study or within  days after receiving their last dose of study drug.
Female patients who:\r\n* Are postmenopausal for at least  year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential:\r\n** Agree to practice  highly effective method and  additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through  months after the last dose of study drug (female and male condoms should not be used together), OR\r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status postvasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through  months after the last dose of study drug (female and male condoms should not be used together), OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Female patients who:\r\n* Are postmenopausal for at least  year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential, agree to practice  highly effective method and  additional (barrier) of contraception, at the same time, from the time of signing the informed consent through  months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (ie, status postvasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through  months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
Female patients must be:\r\n* Postmenopausal for at least  year before the screening visit, OR\r\n* Surgically sterile, OR\r\n* If they are of childbearing potential\r\n** Agree to practice  highly effective method and one additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through  months after the last dose of study drug (female and male condoms should not be used together), OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post-vasectomy) must:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through  months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Adequate contraception as follows:\r\n* For women:\r\n** Postmenopausal for at least  year before the screening visit, OR\r\n** Surgically sterile, OR\r\n** If they are of childbearing potential, agree to practice  effective method of contraception, and  additional (barrier) method, at the same time, from the time of signing the informed consent through  days (or longer, as mandated by local labeling [e.g. United States Package Insert (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n* For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n** Agree to practice highly effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** Agree not to donate sperm during the course of this study or  days after receiving their last dose of study drug
Female patients who: are postmenopausal for at least  year before the screening visit, OR are surgically sterile, OR if they are of childbearing potential, agree to practice  effective method of contraception and one additional effective (barrier) method, at the same time, from the time of signing the informed consent through  days (or longer, as mandated bu local labeling [eg, United States Prescribing Information (USPI), Summary of Product Characteristics (SmPC), etc;]) after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, ad lactational amenorrhea are not acceptable methods of contraception); female and male condoms should not be used together
Male patients, even if surgically sterilized (ie, status post-vasectomy), who: agree to practice highly effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, ad lactational amenorrhea are not acceptable methods of contraception); female and male condoms should not be used together; agree not to donate sperm during the course of this study or  days after receiving their last dose of study drug
Sexually active subjects and their partners must agree to use medically accepted methods of contraception\r\n* For women:\r\n** Postmenopausal for at least  year before the screening visit, OR\r\n** Surgically sterile, OR\r\n** Agree to practice  effective method of contraception and  additional effective (barrier) method at the same time, from the time of signing the informed consent through  days (or longer, as mandated by local labeling [e.g. United States product insert (USPI), summary of product characteristics (SmPC), etc.] after the last dose of study drug, OR\r\n**Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* For men:\r\n** Even if surgically sterilized (i.e., status post-vasectomy), they must agree to practice highly effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug, OR\r\n** Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)\r\n** Agree not to donate sperm during the course of this study or  days after receiving their last dose of study drug
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
Female patients who:\r\n* Are postmenopausal for at least  year before the screening visit, OR\r\n* Are surgically sterile, OR\r\n* If they are of childbearing potential:\r\n* Agree to practice  highly effective method and  additional effective (barrier) method of contraception at the same time, from the time of signing the informed consent through  months after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through  months after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.). Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.).
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together). Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
If they are of childbearing potential:\r\n* Agree to practice  highly effective method and  additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through  months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
Male patients, even if surgically sterilized (i.e., status post vasectomy), who:\r\n* Agree to practice effective barrier contraception during the entire study treatment period and through  months after the last dose of study drug (female and male condoms should not be used together), or\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject; (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception)
For women:\r\n* Postmenopausal for at least  year before the screening visit, OR\r\n* Surgically sterile, OR - If they are of childbearing potential, agree to practice  effective methods of contraception and  additional effective (barrier) method, at the same time, from the time of signing the informed consent through  days (or longer, as mandated by local labeling [e.g. United States product insert (USPI), summary of product characteristics (SmPC), etc;]) after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal, spermicides only and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together)
For men, even if surgically sterilized (i.e., status post-vasectomy), they must:\r\n* Agree to practice highly effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug, OR agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together);\r\n* Agree not to donate sperm during the course of this study or  days after receiving their last dose of study drug
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) Male participant, even if surgically sterilized (that is, status postvasectomy), who:
Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [example, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
Women of child bearing potential must have a negative serum or urine pregnancy test within  days of registration and must agree to:\r\n* Practice  highly effective method of contraception and  additional effective (barrier) method, at the same time, from the time of signing the informed consent through  days (or longer, as mandated by local labeling [e.g., United Surgical Partners International (USPI), Summary of Product Characteristics (SmPC), etc.;]) after the last dose of study drug, OR\r\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient; NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together
Male patients, even if surgically sterilized (i.e., status postvasectomy) must agree to:\r\n* Practice highly effective barrier contraception during the entire study treatment period and through  days after the last dose of study drug, OR\r\n* Practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient;  NOTE: Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception; female and male condoms should not be used together\r\n* Not to donate sperm during the course of this study or within  days after receiving their last dose of study drug