Under this subcontract, UM personnel, Dr. Daniel Almirall will be responsible for working with the Rochester data core on all methodological aspects of the proposed study. He will participate in all other scientific aspects of the project. Specifically, Dr. Almirall will assist with further refinements of the randomized trial design, if needed, during the initial phases of the study. Dr. Almirall will be responsible for developing the data analysis plan and directing all primary and secondary analyses. He will provide direction and consultation to the data core analyst at Rochester. Dr. Almirall will maintain close collaboration with Dr. Tristram Smith and other project team members, through semi-monthly phone meetings, ongoing email correspondence and annual site visits and meeting at conferences.