While this contract was awarded in January 2015, it was finally approved in April 2016. Thus, all activities described in this Annual Report correspond to activities performed between April and September 2016. Despite these challenges, the project is now well underway and on track. A summary of accomplishments to date include HRPO approval, Chart reviews to identify eligible subjects for this study at UCSF and Mt Sinai, Clinical evaluation and invitations to participate, mailing kits have been designed, prepared and started to being distributed to eligible participants, bacterial DNA is being purified from stool samples, quality control is being performed and Tob12D2 mice are currently being derived germ-free. These activities encompass most of the items described in the original SOW. Finally, while expenses have been posted according to the delayed start, the project is financially on track.