Ethics approval and consent to participate
This study conducted in accordance with the Declaration of Helsinki, was granted approval by the UCSD Human Research Protections Program (#151294). Written, informed consent was obtained from each participant on the night prior to their procedure after a detailed explanation of the risks and benefits of participating was conducted and all participant and family questions were answered. The study was registered at clinicaltrials.gov (NCT 02691013, date of registration: February 24, 2016).