ABSTRACT

A. The Investigator, Research Director, and Study Coordinator will work with the SponsorICRO to develop a subject recruitment plan and ensure the budget reflects these activities.

B. Using the eligibility criteria for the study, the Research Director or Study Coordinator will review records from the Investigator's patient population to determine the suitability and availability of candidates for the protocol. In addition, the Investigator and staff will solicit study subjects through personal contacts in the community.