关键词：临床医学；可行性研究；发病率
摘 要：Year one involved hiring and training staff, preparing all regulatory documents and submitting them for approval, initiating participant recruitment, baseline assessment, and follow- up. Year two focused on recruiting for and completing the feasibility phase of the study, and making necessary protocol amendments prior to the full-trial phase of the study. Year three focused on recruitment and data collection for the full trial phase. Year four continued to focus on recruitment and data collection including implementing a mass mailing to aid in the final recruitment push. We were also approved for a one year No Cost Extension.