Trial status
RECRUITMENT
The study sample was generated and brochures mailed to the first eligible participants on April 1, 2021. Enrollment closed on June 16, 2022. Participant follow-up will end on June 16, 2023. The study recruitment is completed and at time of this paper submission the study is in the data collection phase. Preparation and submission of the manuscript were delayed due to changes in staff including the site PI. The statistical analysis plan was finalized prior to submission and no outcome data analysis will be conducted until after publication of the study’s protocol.
