Adverse events
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT
We will follow the United States Office for Human Research Protections and institutional ethics review board standards for adverse event reporting, including logging adverse events in secure documentation (REDCap), reporting serious adverse events for review to the DSMB and IRB. The MRI protocol debriefing questionnaire will be collected to assess adverse or unintended effects of the mbNF procedure, including physical or psychological discomfort during MRI scanning. Adverse events arising from participant reports and interviews, including suicidal thoughts and behaviors, will be reported as adverse events.