If this is the patient’s only hesitation about participating in the study, remind them that they are permitted to withdraw from the study at any point in time. The data for the first 12 months (i.e., the primary study) is the most important, so we would like for them to participate for at least that long. However, if they want to drop out after that they can certainly do so. All they have to do is notify us when the time comes that they no longer wish to continue in the study.