Temporary halt for reasons of subject safety
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable cause. Written notification, documenting the reason for study suspension or termination, will be provided by the suspending or terminating party to study participants, investigator, funding agency, the Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor and regulatory authorities. If the study is prematurely terminated or suspended, the Principal Investigator (PI) will promptly inform study participants, the Institutional Review Board (IRB), and sponsor and will provide the reason(s) for the termination or suspension. Study participants will be contacted, as applicable, and be informed of changes to study visit schedule.Circumstances that may warrant termination or suspension include, but are not limited to:Determination of unexpected, significant, or unacceptable risk to participantsDemonstration of efficacy that would warrant stoppingInsufficient compliance to protocol requirementsData that are not sufficiently complete and/or evaluableDetermination that the primary endpoint has been metDetermination of futilityStudy may resume once concerns about safety, protocol compliance, and data quality are addressed, and satisfy the sponsor, IRB and as applicable, Food and Drug Administration (FDA).