Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: has covid-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): fevers or at least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia or anosmia or other clinical symptoms or signs of covid-19 that are not otherwise explained by comorbidities or co-diagnoses pcr+ test for sars-cov-2. has new signs or symptoms of covid-19 that began ≤7 days of anticipated first dose of study drug. persons ≥18 years old. is admitted and is anticipated to remain in the hospital for ≥ 24 hours. is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (soc). is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. pregnancy and contraception: treatment with eidd-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. extreme care must be taken to avoid pregnancy during the study and for 4 days after completion of eidd 2801 dosing in female participants and for 4 days after completion of eidd-2801 dosing in female partners of male participants. a female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: is not a woman of childbearing potential (wocbp) or is a wocbp and using a contraceptive method that is highly effective (a low user dependency method or a user-dependent method in combination with a barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in appendix 2 during the intervention period and for at least 4 days after the last dose of study intervention. the investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. a wocbp must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. given the elevated risk of venous thrombotic events in patients hospitalized with covid 19 (benson et al 2020; spratt et al 2020), estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant's hospitalization. if contraceptives are interrupted as standard of care management of covid-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. male participants are eligible to participate if they agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a wocbp who is not currently pregnant. note: men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. • contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

inclusion criteria: has covid-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): fevers or at least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia or anosmia or other clinical symptoms or signs of covid-19 that are not otherwise explained by comorbidities or co-diagnoses pcr+ test for sars-cov-2. has new signs or symptoms of covid-19 that began ≤7 days of anticipated first dose of study drug. persons ≥18 years old. is admitted and is anticipated to remain in the hospital for ≥ 24 hours. is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (soc). is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. pregnancy and contraception: treatment with eidd-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. extreme care must be taken to avoid pregnancy during the study and for 4 days after completion of eidd 2801 dosing in female participants and for 4 days after completion of eidd-2801 dosing in female partners of male participants. a female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: is not a woman of childbearing potential (wocbp) or is a wocbp and using a contraceptive method that is highly effective (a low user dependency method or a user-dependent method in combination with a barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in appendix 2 during the intervention period and for at least 4 days after the last dose of study intervention. the investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. a wocbp must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. given the elevated risk of venous thrombotic events in patients hospitalized with covid 19 (benson et al 2020; spratt et al 2020), estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant's hospitalization. if contraceptives are interrupted as standard of care management of covid-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. male participants are eligible to participate if they agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a wocbp who is not currently pregnant. note: men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. • contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

May 22, 2021, 12:32 a.m. usa

inclusion criteria: 1. has covid-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): - fevers or - at least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia or - anosmia or - other clinical symptoms or signs of covid-19 that are not otherwise explained by comorbidities or co-diagnoses 2. pcr+ test for sars-cov-2. 3. has new signs or symptoms of covid-19 that began ≤7 days of anticipated first dose of study drug. 4. persons ≥18 years old. 5. is admitted and is anticipated to remain in the hospital for ≥ 24 hours. 6. is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (soc). 7. is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. pregnancy and contraception: treatment with eidd-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. extreme care must be taken to avoid pregnancy during the study and for 4 days after completion of eidd 2801 dosing in female participants and for 4 days after completion of eidd-2801 dosing in female partners of male participants. 8. a female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: - is not a woman of childbearing potential (wocbp) or - is a wocbp and using a contraceptive method that is highly effective (a low user dependency method or a user-dependent method in combination with a barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in appendix 2 during the intervention period and for at least 4 days after the last dose of study intervention. the investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. - a wocbp must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. - the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - given the elevated risk of venous thrombotic events in patients hospitalized with covid 19 (benson et al 2020; spratt et al 2020), estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant's hospitalization. if contraceptives are interrupted as standard of care management of covid-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. 9. male participants are eligible to participate if they agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: - be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or - must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a wocbp who is not currently pregnant. note: men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. • contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

inclusion criteria: 1. has covid-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): - fevers or - at least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia or - anosmia or - other clinical symptoms or signs of covid-19 that are not otherwise explained by comorbidities or co-diagnoses 2. pcr+ test for sars-cov-2. 3. has new signs or symptoms of covid-19 that began ≤7 days of anticipated first dose of study drug. 4. persons ≥18 years old. 5. is admitted and is anticipated to remain in the hospital for ≥ 24 hours. 6. is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (soc). 7. is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. pregnancy and contraception: treatment with eidd-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. extreme care must be taken to avoid pregnancy during the study and for 4 days after completion of eidd 2801 dosing in female participants and for 4 days after completion of eidd-2801 dosing in female partners of male participants. 8. a female participant is eligible to participate if she is not pregnant or breastfeeding and at least one of the following conditions applies: - is not a woman of childbearing potential (wocbp) or - is a wocbp and using a contraceptive method that is highly effective (a low user dependency method or a user-dependent method in combination with a barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in appendix 2 during the intervention period and for at least 4 days after the last dose of study intervention. the investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. - a wocbp must have a negative highly sensitive pregnancy test (serum test is required) within 24 hours before the first dose of study intervention. - the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. - contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - given the elevated risk of venous thrombotic events in patients hospitalized with covid 19 (benson et al 2020; spratt et al 2020), estrogen-containing contraceptives must not be started to fulfill the contraceptive requirement of this study at any time during participant's hospitalization. if contraceptives are interrupted as standard of care management of covid-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. 9. male participants are eligible to participate if they agree to the following during the intervention period and for at least 4 days after the last dose of study intervention: - be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or - must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a wocbp who is not currently pregnant. note: men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. • contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Dec. 12, 2020, 12:31 a.m. usa

inclusion criteria: 1. has covid-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): - fevers or - at least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia or - anosmia or - other clinical symptoms or signs of covid-19 that are not otherwise explained by comorbidities or co-diagnoses 2. pcr+ test for sars-cov-2. 3. has new signs or symptoms of covid-19 that began ≤7 days of anticipated first dose of study drug. 4. persons ≥18 years old. 5. is admitted and is anticipated to remain in the hospital for ≥ 24 hours. 6. is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (soc). 7. is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. pregnancy and contraception: treatment with eidd-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. extreme care must be taken to avoid pregnancy during the study and for 50 days after completion of eidd 2801 dosing in female participants and for 100 days after completion of eidd-2801 dosing in female partners of male participants. 8. female participants of childbearing potential must meet the the following criteria to be enrolled: 1. have a negative serum pregnancy test at screening 2. must agree to undergo a follow-up pregnancy test on study day 28. 3. must agree to use at least 2 forms of contraception during the study and for at least 50 days after dosing of the study drug is complete, as discussed with and approved by the investigator. or must have an azoospermic partner (vasectomized or due to a to medical cause) note: azoospermic partner is acceptable provided that the partner is the sole sexual partner of the woman of childbearing potential and the absence of sperm has been confirmed. note that female not of childbearing potential is defined as either: i. surgically sterile: females who are permanently sterile via hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy by reported medical history and/or medical records. surgical sterilization to have occurred a minimum of 6 weeks, or at the investigator's discretion, prior to screening. or ii. postmenopausal: females at least 60 years of age with amenorrhea for ≥12 months (by history) or 45 years of age with amenorrhea for 12 months without an alternative medical reason with confirmatory follicle stimulating hormone levels of ≥40 miu/ml. the amenorrhea should not be induced by a medical condition such as anorexia nervosa, hypothyroid disease or polycystic ovarian disease, or by extreme exercise. it should not be due to concomitant medications that may have induced the amenorrhea such as oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, or selective estrogen receptor modulators. 9. male participants must refrain from donating sperm during the study and for 100 days after dosing of the study drug is complete. 10. male participants with female partners must have either 1. surgical sterilization (vasectomy ≥1 month before screening) or 2. female partner must be of not be of childbearing potential or - agree to use 2 forms of contraception during the study and for 100 days after dosing of the study drug is complete, as discussed with and approved by the investigator

inclusion criteria: 1. has covid-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): - fevers or - at least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia or - anosmia or - other clinical symptoms or signs of covid-19 that are not otherwise explained by comorbidities or co-diagnoses 2. pcr+ test for sars-cov-2. 3. has new signs or symptoms of covid-19 that began ≤7 days of anticipated first dose of study drug. 4. persons ≥18 years old. 5. is admitted and is anticipated to remain in the hospital for ≥ 24 hours. 6. is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (soc). 7. is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. pregnancy and contraception: treatment with eidd-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. extreme care must be taken to avoid pregnancy during the study and for 50 days after completion of eidd 2801 dosing in female participants and for 100 days after completion of eidd-2801 dosing in female partners of male participants. 8. female participants of childbearing potential must meet the the following criteria to be enrolled: 1. have a negative serum pregnancy test at screening 2. must agree to undergo a follow-up pregnancy test on study day 28. 3. must agree to use at least 2 forms of contraception during the study and for at least 50 days after dosing of the study drug is complete, as discussed with and approved by the investigator. or must have an azoospermic partner (vasectomized or due to a to medical cause) note: azoospermic partner is acceptable provided that the partner is the sole sexual partner of the woman of childbearing potential and the absence of sperm has been confirmed. note that female not of childbearing potential is defined as either: i. surgically sterile: females who are permanently sterile via hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy by reported medical history and/or medical records. surgical sterilization to have occurred a minimum of 6 weeks, or at the investigator's discretion, prior to screening. or ii. postmenopausal: females at least 60 years of age with amenorrhea for ≥12 months (by history) or 45 years of age with amenorrhea for 12 months without an alternative medical reason with confirmatory follicle stimulating hormone levels of ≥40 miu/ml. the amenorrhea should not be induced by a medical condition such as anorexia nervosa, hypothyroid disease or polycystic ovarian disease, or by extreme exercise. it should not be due to concomitant medications that may have induced the amenorrhea such as oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, or selective estrogen receptor modulators. 9. male participants must refrain from donating sperm during the study and for 100 days after dosing of the study drug is complete. 10. male participants with female partners must have either 1. surgical sterilization (vasectomy ≥1 month before screening) or 2. female partner must be of not be of childbearing potential or - agree to use 2 forms of contraception during the study and for 100 days after dosing of the study drug is complete, as discussed with and approved by the investigator

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: 1. has covid-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): - fevers or - at least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia or - anosmia or - other clinical symptoms or signs of covid-19 that are not otherwise explained by comorbidities or co-diagnoses 2. pcr+ test for sars-cov-2. 3. has new signs or symptoms of covid-19 that began ≤7 days of anticipated first dose of study drug. 4. persons ≥18 years old. 5. prior to covid-19 diagnosis was in good health and had controlled chronic conditions - defined by having stable dosing of medications for chronic medical conditions for at least 4 weeks prior to covid-19 symptom onset. 6. is admitted to the johns hopkins medical institutions and anticipated to remain in the hospital for ≥ 24 hours. 7. is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (soc). 8. is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. pregnancy and contraception: no developmental or reproductive studies of eidd-2801 have been conducted. therefore, treatment with eidd-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. extreme care must be taken to avoid pregnancy during the study and for 50 days after completion of eidd 2801 dosing in female participants and for 100 days after completion of eidd-2801 dosing in female partners of male participants. 9. female participants of childbearing potential must meet the the following criteria to be enrolled: 1. have a negative pregnancy test at screening 2. must agree to undergo a follow-up pregnancy test on study day 28. 3. must agree to use at least 2 forms of contraception during the study and for at least 50 days after dosing of the study drug is complete, as discussed with and approved by the investigator. or must have an azoospermic partner (vasectomized or due to a to medical cause) note: azoospermic partner is acceptable provided that the partner is the sole sexual partner of the woman of childbearing potential and the absence of sperm has been confirmed. note that female not of childbearing potential is defined as either: i. surgically sterile: females who are permanently sterile via hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy by reported medical history and/or medical records. surgical sterilization to have occurred a minimum of 6 weeks, or at the investigator's discretion, prior to screening. or ii. postmenopausal: females at least 60 years of age with amenorrhea for ≥12 months (by history) or 45 years of age with amenorrhea for 12 months without an alternative medical reason with confirmatory follicle stimulating hormone levels of ≥40 miu/ml. the amenorrhea should not be induced by a medical condition such as anorexia nervosa, hypothyroid disease or polycystic ovarian disease, or by extreme exercise. it should not be due to concomitant medications that may have induced the amenorrhea such as oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, or selective estrogen receptor modulators. 10. male participants must refrain from donating sperm during the study and for 100 days after dosing of the study drug is complete. 11. male participants with female partners must have either 1. surgical sterilization (vasectomy ≥1 month before screening) or 2. female partner must be of not be of childbearing potential or - agree to use 2 forms of contraception during the study and for 100 days after dosing of the study drug is complete, as discussed with and approved by the investigator

inclusion criteria: 1. has covid-19 disease, defined by having one or more of the following new symptoms and signs (within 7 days): - fevers or - at least one of the following symptoms: cough, shortness of breath, respiratory rate ≥ 20, radiographic evidence of pneumonia or - anosmia or - other clinical symptoms or signs of covid-19 that are not otherwise explained by comorbidities or co-diagnoses 2. pcr+ test for sars-cov-2. 3. has new signs or symptoms of covid-19 that began ≤7 days of anticipated first dose of study drug. 4. persons ≥18 years old. 5. prior to covid-19 diagnosis was in good health and had controlled chronic conditions - defined by having stable dosing of medications for chronic medical conditions for at least 4 weeks prior to covid-19 symptom onset. 6. is admitted to the johns hopkins medical institutions and anticipated to remain in the hospital for ≥ 24 hours. 7. is willing and able to comply with all study procedures including providing informed consent, collection of virology samples, and any safety tests that are not included as part of standard of care (soc). 8. is willing and able to take oral medications, and is anticipated to be able to take the full course of 5 days of study agent. pregnancy and contraception: no developmental or reproductive studies of eidd-2801 have been conducted. therefore, treatment with eidd-2801 is contraindicated in women who are pregnant or nursing and in the male partners of women who are pregnant. extreme care must be taken to avoid pregnancy during the study and for 50 days after completion of eidd 2801 dosing in female participants and for 100 days after completion of eidd-2801 dosing in female partners of male participants. 9. female participants of childbearing potential must meet the the following criteria to be enrolled: 1. have a negative pregnancy test at screening 2. must agree to undergo a follow-up pregnancy test on study day 28. 3. must agree to use at least 2 forms of contraception during the study and for at least 50 days after dosing of the study drug is complete, as discussed with and approved by the investigator. or must have an azoospermic partner (vasectomized or due to a to medical cause) note: azoospermic partner is acceptable provided that the partner is the sole sexual partner of the woman of childbearing potential and the absence of sperm has been confirmed. note that female not of childbearing potential is defined as either: i. surgically sterile: females who are permanently sterile via hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy by reported medical history and/or medical records. surgical sterilization to have occurred a minimum of 6 weeks, or at the investigator's discretion, prior to screening. or ii. postmenopausal: females at least 60 years of age with amenorrhea for ≥12 months (by history) or 45 years of age with amenorrhea for 12 months without an alternative medical reason with confirmatory follicle stimulating hormone levels of ≥40 miu/ml. the amenorrhea should not be induced by a medical condition such as anorexia nervosa, hypothyroid disease or polycystic ovarian disease, or by extreme exercise. it should not be due to concomitant medications that may have induced the amenorrhea such as oral contraceptives, hormones, gonadotropin releasing hormones, anti-estrogens, or selective estrogen receptor modulators. 10. male participants must refrain from donating sperm during the study and for 100 days after dosing of the study drug is complete. 11. male participants with female partners must have either 1. surgical sterilization (vasectomy ≥1 month before screening) or 2. female partner must be of not be of childbearing potential or - agree to use 2 forms of contraception during the study and for 100 days after dosing of the study drug is complete, as discussed with and approved by the investigator