Study oversight
Investigative Team is comprised of the Principal Investigator and six Co-Investigators with specific expertise required for the execution of this trial. Two investigators provide medical oversight and safety review, three provide theoretical and cognitive behavioral oversight, and two provide data management and data acquisition oversight.A data safety monitoring board (DSMB) unaffiliated with the study team and funding agency will evaluate procedures for participant safety and study futility. This board will report directly to the funding agency every 6 months throughout the funding period. The DSMB has no competing interests.