Common use of Number of Study Participants Clause in Contracts

Number of Study Participants. There will be up to about 24 people taking part in this study. You will be in this study for up to about 58 days if you are in Cohort (group) 1, 51 days if you are in Cohort 2 (if done), and 44 days if you are in Cohort 3 (participants of Japanese descent, if done). This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • Up to 5 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each admission has 4 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 2 • Up to 4 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each admission has 4 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 3 • Up to 3 dosing periods during 1 continuous admission o There will be at least 7 days between each dose • 18 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Your eligibility to take part in another study depends on information from this study. You may be eligible to receive a different study drug in another study as early as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug used to treat people is not yet known. Up to 3 cohorts of participants are planned. Dosing is planned as follows: Cohort 2 (optional)

Number of Study Participants. There will be up to about 24 18 people taking joining this part in this of the study. You will be in this study for up to about 58 days if you are in Cohort (group) 1, 51 days if you are in Cohort 2 (if done), and 44 days if you are in Cohort 3 (participants of Japanese descent, if done)77 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves: • Up 1 outpatient run-in period (4 weeks) with 4 outpatient visits to 5 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each admission has 4 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time ) • 1 follow-up visit about dosing period during 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 2 • Up to 4 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each admission has 4 continuous admission. 25 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit to the CRU about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 3 • Up to 3 dosing periods during 1 continuous admission o There will be at least 7 days between each dose • 18 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Your eligibility to take part in another study depends on information from this study. You may be eligible to receive a different study drug in another study as early soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug that will be used to treat people is not yet known. Up to 3 cohorts The dose of participants are plannedstudy drug in this part of the study will be determined based on information from the previous dosing groups. Dosing is planned as follows: Cohort 2 DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 1 to 14 1 18 0.6 mg Saxenda 1.2 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg study drug or placebo *TBD – to be determined. Dosing for this part of the study will be based on data from the earlier dosing groups. It will be randomly assigned, like the flip of a coin, who receives either study drug or placebo You have about a 1 in 3 chance of being on placebo during the study. On study Day -35, you will visit the CRU for your first injection of Saxenda. It will be given to you by a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper arms. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed on how to store the medication. You will be given a dosing diary to record the dosing time of each dose given at home. You will return to the CRU every week during the outpatient run-in period (optionalStudy Days -28, -21, and -14). You will bring your completed dosing diary with you at the time of these visits. During these visits, Saxenda will be administered by the CRU staff and you will be given sufficient supplies for dosing at home. On Study Day -7, you will be admitted to the CRU to continue Saxenda dosing before beginning dosing with study drug or placebo on Study Day 1. Saxenda doses while in the CRU will be given by the study staff, including Day -7 when you check in for the study. You will continue to receive a daily injection of Saxenda through Day -1 of the study. On Day -1 you will fast overnight for at least 10 hours before an OGTT. It will be done at about the same time as scheduled for Day 8. From Days 1 to 14, you will continue to receive Saxenda as a daily injection and you will also receive oral doses of study drug or placebo. On Days 1 – 7 and 9 - 14, you will fast overnight for at least 10 hours before receiving a standard breakfast. Breakfast will be provided about 30 minutes before dosing. It should be completely eaten within 20 minutes. Dosing will take place about 10 minutes after completing breakfast. Saxenda dosing will be within 5 minutes of study drug or placebo dosing. On Day 8, you will fast overnight for at least 10 hours before receiving a single oral dose of study drug or placebo. About 30 minutes after dosing, an OGTT will be done. The timing of the OGTT may be changed based on the study drug blood levels from earlier in the study. An OGTT involves drinking an 8 oz solution containing 75 grams of sugar. It measures how well the body can break down sugar. A blood sample is taken before drinking the solution and approximately 2½ hours after. During this time period, blood samples will be collected approximately every 30 minutes. Both you and the study staff will not know whether you are receiving the study drug or placebo. In case of a medical emergency, the study investigator can find out what you have received if considered necessary. The doses of study drug and placebo that you receive may be compounded in our pharmacy for use in this part of the study. Compounded means that the ingredients are added together and mixed to make the final dose(s). All oral doses will be taken with water. The total fluid volume of doses and water will be about 8 oz (1cup). All doses must be completely swallowed. We will check your mouth after each dose to make sure the study drug or placebo have been swallowed This is a research study. The study drug and Saxenda will be given to you only during this study and not after the study is over. Before any study procedures begin, you will be asked to read, sign, and date this consent document.

Number of Study Participants. There will be up to about 24 people 12 participants taking part in this study. You will be in this study for up to about 58 days if you are in Cohort (group) 1, 51 days if you are in Cohort 2 (if done), and 44 days if you are in Cohort 3 (participants of Japanese descent, if done)47 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • Up to  5 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each during one continuous admission has 4  20 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 2 • Up to 4 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each admission has 4 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 3 • Up to 3 dosing periods during 1 continuous admission o There will be at least 7 days between each dose • 18 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose •  1 follow-up phone call about 4 weeks after the last dose Your eligibility to take part in another study depends on information from this studystudy and previous studies. You may be eligible to receive a different study drug in another study as early soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug used that is currently authorized to treat people COVID patients is not yet known. Up to 3 cohorts of participants are planned300 mg twice a day for 5 days. Dosing in this study is planned as follows: Cohort 2 Study Treatment Sequence Number of Participants Study Period Study Treatment A: 300 mg of study drug (optionaltwo 150 mg tablets, commercial formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment B: 300 mg of study drug (two 150 mg tablets, slower dissolution [slowly dissolves] formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment C: 300 mg of study drug (two 150 tablets, large particle size formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment D: 300 mg of study drug (liquid suspension formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment E: 300 mg of study drug (liquid suspension formulation) The study drug and ritonavir will be given orally (by mouth). The liquid suspension doses that you will receive are compounded in our pharmacy for use in this study. Compounded means that the ingredients are added together and mixed to make the final dose.

Number of Study Participants. There will be up to about 24 12 people taking part in this study. You will be in this study for up to about 58 days if you are in Cohort (group) 1, 51 days if you are in Cohort 2 (if done), and 44 days if you are in Cohort 3 (participants of Japanese descent, if done)35 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • Up to 5  2 dosing periods with separate admissions for each period o There will be at least 7 days between each dose • Each during 1 continuous admission has 4  9 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose •  1 follow-up phone call about 4 weeks after the last dose Cohort 2 • Up to 4 dosing periods with separate admissions for each period o There will be at least 7 5 days between each dose • Each admission has 4 overnight stays at the CRUof rosuvastatin. You will not be able Eligibility to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Cohort 3 • Up to 3 dosing periods during 1 continuous admission o There will be at least 7 days between each dose • 18 overnight stays at the CRU. You will not be able to leave the CRU during that time • 1 follow-up visit about 1 week after the last dose • 1 follow-up phone call about 4 weeks after the last dose Participate in Another Drug Study Your eligibility to take part in another study depends on information from the previous studies, ongoing studies, and this study. You may be eligible to receive a different study drug in another study as early as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer longer, which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. The dose of the study drug that will be used to treat people is not yet known. Up to 3 cohorts One group of participants are plannedplanned for this study. Dosing for this study is planned as follows: Cohort Number of Participants Dosing Period Rosuvastatin will be given as a single 10 mg tablet. Study drug will be given as two 100 mg tablets. Both you and the study staff will know which study treatment you are receiving. On Day 1 of each period, you will receive a standard breakfast before dosing. You will fast overnight (nothing to eat or drink except water) for at least 10 hours before eating breakfast. On Day 1 of Period 1, you will be served breakfast about 2 hours before dosing with rosuvastatin. Breakfast should be completely eaten within 20 minutes. Dosing will follow about 100 minutes after completing breakfast. On Day 1 of Period 2, you will be served breakfast about 30 minutes before dosing with the study drug. Breakfast should be completely eaten within 20 minutes. Dosing with the study drug will follow within 10 minutes of completing breakfast. Dosing with rosuvastatin will follow about 1 ½ hours after study drug dosing. Each dose will be taken with about 8 oz (optional)1 cup) of water. All doses must be completely swallowed. We will check your mouth after each dose to make sure the study drug and rosuvastatin have been swallowed. This is a research study. The study drug and rosuvastatin will be given to you only during this study and not after the study is over. Before any study procedures begin, you will be asked to read, sign, and date this consent document.