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Recruitment Language for Budgets: We are requesting this $X,XXX for recruitment support. These funds will help defray the cost of our labs recruitment efforts and the Recruitment Enhancement Core (REC); a dedicated staff of four recruitment specialists, who will consult with the PI and CRC to develop and implement a unique recruitment plan. This plan will include targeted, strategic activities tailor-made to recruit and retain eligible participants for this trial. Such activities include querying the Research Participant Registry which contains over 12,000 potential study participants, reviewing patient charts or querying in house databases to identify potential participants, developing and placing any print, e-mail or online advertisements, calling on high volume community practitioners to generate referrals, generating study interest though local support and advocacy groups and attending appropriate health fairs. Additionally, they will work with our study staff to provide pre-screening services on all potentially eligible participants, if needed. Finally, they will participate in community outreach efforts designed to build trust and promote the importance of clinical trial participation in order to deliver a more diverse participant base. This process should take anywhere from 30 to 60 days to get up and running and will continue throughout the life of the trial or until our randomization goals are met. It is our goal to provide hard-hitting, targeted recruitment efforts early in the clinical trial process in order to meet our enrollment goals as quickly as possible. The REC is a unique service that The Washington University School of Medicine offers to help sponsors and PI's maximize the attainment of enrollment goals. We believe this additional funding will help us provide a focused, proactive recruitment strategy that will allow us to maximize our enrollment and randomization efforts. Advertising Language for Budgets: In order to ensure the most comprehensive marketing of this trial, we are requesting $X,XXX dollars of advertising support to educate the surrounding potential participants with access to this study site. The advertising dollars will be spent on brochure, flyer and poster development, print and radio media development and facilitating placement in high targeted volunteer areas, as well as focused advertising in numerous internal and external venues. We will also work with our Medical Public Affairs group to secure any Washington University focused local media exposure, such as press releases, TV and radio spots, etc. Advertising dollars will be spent judiciously with return on investment, like patient contacts and enrollment, as the guiding principle. A marketing plan, with rates and schedules of media placement, will be developed and upon approval from the study staff, be implemented. All advertisements will be Washington University IRB approved, and if needed, sent to the sponsor for approval as well. To that end, if there are any sponsor approved articles, flyers, or media developed, could you send them to the Recruitment Enhancement Core in the Center for Clinical Studies, here at Washington University.