Common use of Screening Clause in Contracts

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, and beathing rate will be measured) • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • o Give your past and current medication and treatment history. This includes any over-the-the- counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, and beathing rate breathing rate) will be measured) • measured o Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • COVID-19 procedures: o You may be asked to complete a COVID-19 questionnaire o You may be tested for COVID-19 o at each visit to the CRU ▪ COVID-19 testing will be done by collection of a swab samplesample o Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves o You may be required to always wear a mask. If required, it will be provided to you • Safety lab tests will be done from blood and urine samples. In additionThis includes: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Blood pregnancy test for women able to check your albumin/ creatinine ratio have children o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always rightcorrect so additional follow-up with your primary care doctor may be needed. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, pressure and heart rate, and beathing rate ) will be measured) measured • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. • Safety lab tests will be done from blood and urine samples. In additionThis includes: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: •  Give your race, age, gender, and ethnicity •  Give your medical history o You must review and confirm the information in your medical history questionnaire •  Give your drug, alcohol, and tobacco use history •  Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • o You must review and confirm the information in your medical history questionnaire  Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study •  Xxxxx xxxxx (blood pressure, heart rate, breathing rate, and beathing rate will be measured) • Electrocardiogram (ECGoral temperature) will be collected. An ECG measures measured  ECGs (triplicate measurements) will be collected  Complete a COVID-19 questionnaire  All participants will be swabbed for COVID-19 at each visit to the electrical activity of the heart • CRU o Staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves  You may will be provided a mask, and are required to wear it at all times  You will be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. • sample  Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, hepatitis C, TSH and hepatitis C o Blood free T4 (tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check of your thyroid function (Part B and Part C onlyfunction) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children •  The study investigator may decide to do an alcohol breath test •  The use of proper birth control will be reviewed (males only) •  Physical exam. This may be done at screening or when you check-in for the study  You will be asked “How do you feel?” HIV H IV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-over the counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, breathing rate, and beathing rate temperature) will be measured) measured • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. • Safety lab tests will be done from blood and urine samples. In additionThis includes: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests test for thyroid stimulating hormone (TSH), calcitonin (a hormone secreted by the thyroid), amylase and (an enzyme that helps with digestion), lipase (enzymes an enzyme that help with digestionbreaks down fats), Part B onlyand total bile acids (produced when the body metabolizes [processes] cholesterol) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, pressure and heart rate, and beathing rate ) will be measured) measured • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • COVID-19 procedures: o You may be asked to complete a COVID-19 questionnaire o You may be tested for COVID-19 o at each visit to the CRU ▪ COVID-19 testing will be done by collection of a swab samplesample o Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves o You may be required to wear a mask at all times. If required, it will be provided to you • Safety lab tests will be done from blood and urine samples. In additionThis includes: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Blood pregnancy test for women able to check your albumin/ creatinine ratio have children o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, pressure and heart rate, and beathing rate will be measured) • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • COVID-19 procedures: o You may be asked to complete a COVID-19 questionnaire o You may be tested for COVID-19 o at each visit to the CRU ▪ COVID-19 testing will be done by collection of a swab samplesample o Staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves o You may be required to wear a mask at all times. If required, it will be provided to you • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o ▪ Part A only ⮚ Blood tests to see how your blood clots ▪ Fibrinogen ▪ and if you have any findings that indicate you may be at higher risk for developing a blood clot ✓ Anti-phospholipid antibodies (proteins) ✓ PT/INR/aPTT o Blood tests for amylase ✓ D-Dimer ✓ Protein C activity ✓ Protein S (activity and lipase (enzymes that help with digestion, Part B onlyantigen) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 ✓ Antithrombin activity ✓ APC resistance ✓ Fibrinogen o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-over- the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o exam. This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, breathing rate, and beathing rate oral [by mouth] temperature) will be measured) measured • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You Complete a COVID-19 questionnaire • All participants may be tested for COVID-19 at each visit to the CRU o COVID-19 testing Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves ▪ You will be done provided a mask, and are required to wear it at all times ▪ You will be tested for COVID-19 by collection of a swab sample. sample • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for aPTT and PT-INR (tests of your blood’s ability to clot) o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase tuberculosis (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B onlyTB) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests Positive results for TB may have to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 be reported to the State Department of Health o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency immune deficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, and beathing rate oral temperature) will be measured) measured • Electrocardiogram Electrocardiograms (ECG) will be collected. An ECG measures the electrical activity of the heart • You may Complete a COVID-19 questionnaire • All participants will be tested for COVID-19 at each visit to the CRU o COVID-19 testing Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves ▪ You will be done provided a mask, and are required to wear it at all times ▪ You will be tested for COVID-19 by collection of a swab sample. sample • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus aPTT, PT-INR, and fibrinogen (tests of your blood’s ability to clot) o Blood tests for HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • Physical exam. This may be done at screening or when you check-in for the study • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, breathing rate, and beathing rate oral temperature) will be measured) measured • Electrocardiogram (ECGECG – triplicate measurements) will be collected. An ECG measures the electrical activity of the heart • You may Complete a COVID-19 questionnaire • All participants will be tested for COVID-19 at each visit to the CRU o COVID-19 testing Staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves ▪ You will be done provided a mask, and are required to wear it at all times ▪ You will be tested for COVID-19 by collection of a swab sample. sample • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, hepatitis C, thyroid stimulating hormone (TSH), and hepatitis C o Blood tests free thyroxine (T4) (a test that helps to see evaluate how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B onlythyroid is working) o Blood tests for a lipid PTT, PT-INR, and fibrinogen (fatstests of your blood’s ability to clot) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • Genomics: A blood sample will be taken to determine if you have 2 genes (called HLA-B*1502 and HLA-A-3101). If you are positive for one or the other you will not be able to be in the study. • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed • Physical exam. This may be done at screening or when you check-in for the study • Columbia Suicide Severity Rating Scale (males only) C-SSRS), Lifetime o This is an evaluation to see if you have had suicidal thoughts or behaviors over the course of your lifetime • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • The proper use of birth control will be reviewed • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, oral temperature, and beathing rate breathing rate) will be measured) measured • Electrocardiogram Electrocardiograms (ECGECGs) will be collected. An ECG measures ECGs measure the electrical activity of the heart • You may be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. • Safety lab tests will be done from blood and urine samples. In additionThis includes: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • All participants will be swabbed for COVID-19 at each visit to the CRU o Staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves ▪ You will be provided a mask, and are required to wear it at all times ▪ You will be tested for COVID-19 by collection of a swab sample • The study investigator may decide to do an alcohol breath test • The use of proper birth control will Physical exam. This may be reviewed (males only) done at screening or when you check-in for the study • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, and beathing rate oral temperature) will be measured) measured • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may Complete a COVID-19 questionnaire • All participants will be tested for COVID-19 at each visit to the CRU o COVID-19 testing Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves ▪ You will be done provided a mask, and are required to wear it at all times ▪ You will be tested for COVID-19 by collection of a swab sample. sample • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests test for amylase and lipase tuberculosis (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B onlyTB) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests Positive results for TB may have to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 be reported to the State Department of Health o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • Physical exam. This may be done at screening or when you check-in for the study • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: •  Give your race, age, gender, and ethnicity •  Give your medical history o You must review and confirm the information in your medical history questionnaire •  Give your drug, alcohol, and tobacco use history •  Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days •  Height and weight will be measured •  Physical exam will be done o This may be done at screening or when you check-in for the study •  Xxxxx xxxxx (blood pressure, pressure and heart rate, and beathing rate ) will be measured) • measured  Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart •  COVID-19 procedures: o You may be asked to complete a COVID-19 questionnaire o You may be tested for COVID-19 o at each visit to the CRU  COVID-19 testing will be done by collection of a swab samplesample o Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves o You may be required to wear a mask at all times. • If required, it will be provided to you  Safety lab tests will be done from blood and urine samples. In additionThis includes: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests test for thyroid stimulating hormone (TSH) to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 is working o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children •  The study investigator may decide to do an alcohol breath test •  The use of proper birth control will be reviewed (males only) •  You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: •  Give your race, age, gender, and ethnicity •  Give your medical history o You must review and confirm the information in your medical history questionnaire •  Give your drug, alcohol, and tobacco use history •  Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days •  Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study •  Xxxxx xxxxx (blood pressure, heart rate, and beathing rate oral temperature) will be measured) • Electrocardiogram measured  Electrocardiograms (ECG) will be collected. An ECG measures the electrical activity of the heart • You may  Complete a COVID-19 questionnaire  All participants will be tested for COVID-19 at each visit to the CRU o COVID-19 testing Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves  You will be done provided a mask, and are required to wear it at all times  You will be tested for COVID-19 by collection of a swab sample. • sample  Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus aPTT, PT-INR, and fibrinogen (tests of your blood’s ability to clot) o Blood tests for HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children •  The study investigator may decide to do an alcohol breath test •  The use of proper birth control will be reviewed (males only) •  Physical exam. This may be done at screening or when you check-in for the study  You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: •  Give your race, age, gender, and ethnicity •  Give your medical history o You must review and confirm the information in your medical history questionnaire •  Give your drug, alcohol, and tobacco use history •  Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days •  Height and weight will be measured •  Physical exam will be done o This may be done at screening or when you check-in for the study •  Xxxxx xxxxx (blood pressure, heart rate, breathing rate, and beathing rate oral temperature) will be measured) • measured  Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may  Complete a COVID-19 questionnaire  All participants will be tested for COVID-19 at each visit to the CRU o COVID-19 testing Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves  You will be done provided a mask, and are required to wear it at all times  You will be tested for COVID-19 by collection of a swab sample. • sample  Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • and cotinine (by-product of nicotine)  The study investigator may decide to do an alcohol breath test •  The use of proper birth control will be reviewed (males only) •  You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency immune deficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: •  Give your race, age, gender, and ethnicity •  Give your medical history o You must review and confirm the information in your medical history questionnaire •  Give your drug, alcohol, and tobacco use history •  Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days •  Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study •  Xxxxx xxxxx (blood pressure, heart rate, and beathing rate oral temperature) will be measured) • Electrocardiogram measured  Electrocardiograms (ECGECGs) will be collected. An ECG measures the electrical activity of the heart •  Complete a COVID-19 questionnaire  All participants will be swabbed for COVID-19 at each visit to the CRU o Staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves  You may will be provided a mask, and are required to wear it at all times  You will be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. • sample  Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children •  The study investigator may decide to do an alcohol breath test •  The use of proper birth control will be reviewed (males only) •  Physical exam. This may be done at screening or when you check-in for the study  You will be asked “How do you feel?” HIV H IV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency immune deficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, pressure and heart rate, and beathing rate ) will be measured) measured • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. • Safety lab tests will be done from blood and urine samples. In additionThis includes: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) and cotinine (a byproduct of nicotine) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, supplements taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, and beathing rate oral temperature) will be measured) measured • Electrocardiogram (ECG) will be collected. An ECG measures ECGs measure the electrical activity of the heart • You may be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio and cotinine o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • All participants will be swabbed for COVID-19 at each visit to the CRU o Staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves ▪ You will be provided a mask, and are required to wear it at all times ▪ You will be tested for COVID-19 by: ➢ Collection of a swab sample • The study investigator may decide to do an alcohol breath test • Physical exam. This may be done at screening or when you check-in for the study • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency immune deficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, and beathing rate ) will be measured) measured • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • COVID-19 procedures: o You may be asked to complete a COVID-19 questionnaire o You may be tested for COVID-19 o at each visit to the CRU ▪ COVID-19 testing will be done by collection of a swab samplesample o Study staff may be wearing masks, face xxxxxxx, respirator hoods, gowns, and gloves o You may be required to wear a mask at all times. If required, it will be provided to you • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus aPTT, PT-INR, and fibrinogen (tests of your blood’s ability to clot) o Blood tests for HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests Females able to check your albumin/ creatinine ratio have children will have a blood pregnancy test o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males females only) • Physical exam. This may be done at screening or when you check-in for the study • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After you sign and date the consent document, you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that will be completed during the study (including screening) are described below. If you do not meet the requirements, you will not be able to take part in the study. The study investigator or study staff will explain why. As part of screening, you must complete all of the items listed below: • Give your race, age, gender, and ethnicity • Give your medical history o You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give your past and current medication and treatment history. This includes any over-the-counter or prescription drugs, such as vitamins, dietary supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, pressure and heart rate, and beathing rate will be measured) • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o COVID-19 testing will be done by collection of a swab sample. sample • Safety lab tests will be done from blood and urine samples. In addition: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Blood test for hemoglobin A1c (HbA1c) o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • You will complete the Columbia Suicide Severity Rating Scale (C-SSRS) o This is a scale to assess if a person is thinking about suicide or is exhibiting suicidal behaviors • You will complete the Patient Health Questionnaire-9 (PHQ-9) o This a scale to assess depressive symptoms • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do you feel?” HIV and Hepatitis Testing HIV, hepatitis B, and hepatitis C will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permission.

Screening. After If you decide to participate, and after you sign this informed consent form, the following tests and date the consent document, procedures will be done to make sure it is safe for you will begin screening. The purpose of the screening is to find out if you meet all of the requirements to take part in the study. Procedures that Most of these tests will be completed during done within 14 days before you receive the first dose of study (including screening) are described below. If medication, some may be done within 28 days before you do not meet receive the requirements, you will not be able to take part in the studyfirst dose. The study investigator or study staff screening process may take more than one day to complete. • Review of your past medical history: You will explain why. As part of screeningbe asked several basic questions (for example, you must complete all of the items listed below: • Give your racegender, age, gender, and ethnicity • Give your medical history o ethnicity). You must review and confirm the information in your medical history questionnaire • Give your drug, alcohol, and tobacco use history • Give will be asked about your past and current medication health problems and treatment about any prior surgical procedures you have had that are not related to your disease. • Review of your cancer history: You will be asked about the prior surgical procedures you have had that are related to your disease and about the cancer therapies you have received for your disease. This includes any over-the-counter or prescription drugs• Review of your current medications: You will be asked about the medications you use currently as of the day of screening, such as including vitamins, dietary nutritional supplements, or herbal supplements, taken in the past 28 days • Height and weight will be measured • Physical exam will be done o This may be done at screening or when you check-in for the study • Xxxxx xxxxx (blood pressure, heart rate, and beathing rate will be measured) • Electrocardiogram (ECG) will be collected. An ECG measures the electrical activity of the heart • You may be tested for COVID-19 o COVID-19 testing will be done medications not prescribed by collection of a swab sampleyour doctor. • Safety lab tests will be done from blood and urine samples. In additionPerformance status: o Blood tests for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C o Blood tests to see how your blood clots ▪ Fibrinogen ▪ PT/INR/aPTT o Blood tests for amylase and lipase (enzymes that help with digestion, Part B only) o Blood tests for a lipid (fats) panel (Part B only) ▪ Total cholesterol ▪ Triglycerides ▪ HDL ▪ Direct HDL o Blood tests to check your thyroid function (Part B and Part C only) ▪ TSH ▪ Free T4 o Urine to test for drugs of abuse (illegal and prescription) o Urine tests to check your albumin/ creatinine ratio o Females who have not had a period for at least 12 months in a row will have a blood hormone test to confirm they cannot have children • The study investigator may decide to do an alcohol breath test • The use of proper birth control will be reviewed (males only) • You will be asked “How do to rate how well you feel?” HIV can carry out your normal daily activities (this is called performance status). • Xxxxx xxxxx: You will have your temperature and Hepatitis Testing HIVxxxxx xxxxx (including your pulse, hepatitis Bbreathing rate, blood pressure, and hepatitis C oxygen concentration in your blood) measured to check your overall health. • Physical exam: You will have a complete physical examination including an assessment of your general appearance and measurement of your height and weight. • Eye exam: You will have an exam of your eyes, including an evaluation of your corneas, which are the transparent layers that form the front of the eyes. • Routine blood and urine tests: Blood and urine will be tested at screening. If anyone is exposed to your blood during the study, you will have these tests done again. If you have a positive test, you cannot be in or remain in the study. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). If your HIV test is positive, you will be told about the results. It may take weeks or months after being infected with HIV collected for the test to be positive. The HIV test is not always right. Having certain infections or positive test results may have to be reported to the State Department of Health. This includes results for HIV, hepatitis, and other infections. If you have any questions about what information is required to be reported, please ask the study investigator or study staff. Although this testing is meant to be private, complete privacy cannot be guaranteed. For example, it is possible for a court of law to get health or study records without your permissionroutine laboratory tests.