Our work is conducted within a research framework. Participants meet with a physician for a complete evaluation, and, when necessary, a consultation with an appropriate medical specialist follows. Relevant laboratory and radiological examinations are undertaken as described in the applicable research protocol. Safety assessments may include adverse-event questionnaires, physical exams, and blood tests at specified intervals. The schedule of assessments is described in each research protocol reviewed by an Institutional Review Board. Our products are investigational and have not been approved by the FDA.