Created at Source Raw Value Validated value
June 25, 2024, noon usa

* pregnant, breastfeeding, or unwilling to practice birth control during participation in the study * active malignancy requiring systemic chemotherapy or surgery in the preceding 3 months or for whom such therapies are expected in the subsequent 6 months * decompensated liver disease as defined by the presence of ascites, encephalopathy, esophageal or gastric varices, or persistent jaundice * serious illness requiring systemic treatment and/or hospitalization in the 3 months prior to study enrollment * concurrent treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, il-2, interferon-alpha, methotrexate, cancer chemotherapy). note: use of inhaled or nasal steroid is not exclusionary. * serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent. * current alcohol use disorder or hazardous alcohol use (\>7 drinks per week for women or \> 14 drinks per week for men) as determined by clinical evaluation. * current use of any drug formulation that contains alcohol or that might contain alcohol * current use of warfarin. * clinically active hepatitis determined by the study physician; alt or ast \> 3 x the upper limit of normal or total bilirubin outside the normal range. * allergy to rubber or thiuram derivatives

* pregnant, breastfeeding, or unwilling to practice birth control during participation in the study * active malignancy requiring systemic chemotherapy or surgery in the preceding 3 months or for whom such therapies are expected in the subsequent 6 months * decompensated liver disease as defined by the presence of ascites, encephalopathy, esophageal or gastric varices, or persistent jaundice * serious illness requiring systemic treatment and/or hospitalization in the 3 months prior to study enrollment * concurrent treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, il-2, interferon-alpha, methotrexate, cancer chemotherapy). note: use of inhaled or nasal steroid is not exclusionary. * serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent. * current alcohol use disorder or hazardous alcohol use (\>7 drinks per week for women or \> 14 drinks per week for men) as determined by clinical evaluation. * current use of any drug formulation that contains alcohol or that might contain alcohol * current use of warfarin. * clinically active hepatitis determined by the study physician; alt or ast \> 3 x the upper limit of normal or total bilirubin outside the normal range. * allergy to rubber or thiuram derivatives

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

- pregnant, breastfeeding, or unwilling to practice birth control during participation in the study - active malignancy requiring systemic chemotherapy or surgery in the preceding 3 months or for whom such therapies are expected in the subsequent 6 months - decompensated liver disease as defined by the presence of ascites, encephalopathy, esophageal or gastric varices, or persistent jaundice - serious illness requiring systemic treatment and/or hospitalization in the 3 months prior to study enrollment - concurrent treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, il-2, interferon-alpha, methotrexate, cancer chemotherapy). note: use of inhaled or nasal steroid is not exclusionary. - serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent. - current alcohol use disorder or hazardous alcohol use (>7 drinks per week for women or > 14 drinks per week for men) as determined by clinical evaluation. - current use of any drug formulation that contains alcohol or that might contain alcohol - current use of warfarin. - clinically active hepatitis determined by the study physician; alt or ast > 3 x the upper limit of normal or total bilirubin outside the normal range. - allergy to rubber or thiuram derivatives

- pregnant, breastfeeding, or unwilling to practice birth control during participation in the study - active malignancy requiring systemic chemotherapy or surgery in the preceding 3 months or for whom such therapies are expected in the subsequent 6 months - decompensated liver disease as defined by the presence of ascites, encephalopathy, esophageal or gastric varices, or persistent jaundice - serious illness requiring systemic treatment and/or hospitalization in the 3 months prior to study enrollment - concurrent treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, il-2, interferon-alpha, methotrexate, cancer chemotherapy). note: use of inhaled or nasal steroid is not exclusionary. - serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent. - current alcohol use disorder or hazardous alcohol use (>7 drinks per week for women or > 14 drinks per week for men) as determined by clinical evaluation. - current use of any drug formulation that contains alcohol or that might contain alcohol - current use of warfarin. - clinically active hepatitis determined by the study physician; alt or ast > 3 x the upper limit of normal or total bilirubin outside the normal range. - allergy to rubber or thiuram derivatives