This is a well-prepared, federally-funded research proposal. Although the information provided within the YODA-specific proposal did not answer all of my questions, the inclusion of the funded PCORI grant proposal, the Appendix material, and other related materials helped me to clearly understand the purpose and scope of the research project. However, one question that I was left with and that should be clarified prior to approval is what observational data will be used to “transport” the estimated effects from the 9 requested J&J RCTs, all of which are studying patients with diabetes.