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prescribing information and panitumumab Investigator's Brochure. Thirty-two Institutional Review Boards at Level I trauma centers have reviewed the study protocol and Investigator's Brochure that summarize all prior studies, conducted community consultation and public disclosure activities, and approved patient enrollment. We developed and are reviewing with the clinical sites and regulatory agencies the Phase II protocol, investigator's brochure and case report forms to obtain regulatory clearance and institutional clearance from the clinical sites to commence patient enrollment in the Phase II study. |
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