11.2 Data Safety Monitoring Plan The PI and the research personnel will meet at least monthly to review all adverse events. Unexpected adverse events and/or serious adverse events will be reported to the MMC IRB. If trends are noted and /or risks warrant it, accrual will be interrupted and /or the protocol and/or consent will be modified accordingly. The MMC IRB will review submitted adverse events monthly to also evaluate trends and will require follow up plans from the principal investigator whenever a trend is identified.