Local data and safety monitoring will be conducted by the PI who will meet regularly with the study team to review new information from clinical ratings, assessments, and medical records for each subject. Study-related adverse events or threats to subject confidentiality will be monitored, and any needed safety changes will be addressed. Assessment of adverse events, including grading of severity and attribution to research, will be conducted at each visit and noted on the rating coversheet. The PI will report all unanticipated problems within 5 working days from becoming aware of the event. The PI will evaluate all adverse events and determine whether the event affects the Risk/Benefit ratio of the study, and whether modifications to the protocol or consent form are required.