| What is the purpose of the clinical research study? The purpose of a clinical research study is to test the safety and effectiveness of an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA). |
| What is expected from me as a study participant? You will be made aware of the study time commitments and responsibilities by the study staff once you decide to participate in the study. You will be reading and signing the informed consent and will follow the study rules and instructions provided by the study staff. |
| What are the potential risks and discomforts that I may experience in taking the drugs in this clinical trial? Drugs in clinical trials may cause side effects and discomforts in some people and some of these side effects may be unknown. You must tell your study doctor or study staff about any side effects you may have. |
| What if I am taking placebo instead of study drug during the study? Some people in the study will get a placebo instead of a study drug. Placebo is a pill that looks like a drug but has no drug in it. If you take a placebo during the study, it is possible that your symptoms will stay the same or may get worse. Please ask the study doctor or study staff if you have any questions about the placebo. |
| What happens if I decide to no longer participate in this study? Your participation in this study is completely voluntary. You may discontinue your involvement at any time without penalty or loss of benefits to which you are otherwise entitled. |
| Is there a payment if I decide to participate? You may be reimbursed for travel expenses, meals, and your time for participation in this study. |
| How will my Personal Health Information be Protected? Every effort will be taken to maintain your privacy. Your records and samples will only be identified by a code. Only the study doctor and authorized personnel will be able to connect this code to your name. Your personal health information will be kept confidential and, unless required by law, will not be made publicly available. |
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