The JANIX dedicated medical monitor will possess a detailed grasp of the research protocol and ongoing study activities with an emphasis on data integrity, protocol adherence and study participant safety issues. This will include the review of adverse events and reasons for losses to follow up, raising any concerns or issues with the Sponsor and the PI, and will assist the Sponsor and PI during the continuation, modification or conclusion of the trial, while protecting the confidentiality of the trial data and the results of monitoring. Depending on the scope of the medical monitoring role, the JANIX Medical Monitor can participate in the formative stages of the study for structured adverse event determination, monitoring, and reporting systems, including standardized forms and protocols for referring and/or treating subjects experiencing adverse events.