Before you participate in a research study, you will be provided materials that thoroughly explains the trial. It details what kind of treatment you will receive, what type of tests or procedures will be done as part of your participation in addition to all of the benefits and risks associated with the medication or procedure. You will receive an informed consent form to sign before you begin study participation. The informed consent is a process required by the US Food and Drug Administration (FDA) that ensures patients are given complete information about a clinical trial prior to their participation. In order to join any clinical trial, each participant must read and sign an informed consent form before any treatment or testing related to the clinical trial is started. This is to help ensure that every participant understands his/her role and rights in the clinical trial. You will be given a copy of the informed consent after it is signed.
At the start and throughout the study, you will be able to ask our study team any questions you may have regarding the study or treatment. Participants may withdraw from a study at any time, even if you have not completed all of the scheduled visits of the study.