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For patients with systemic symptoms such as fever, malaise, and myalgias, cytomegalovirus infection should be ruled out with mucosal biopsy studies, particularly if the patient is receiving therapy with immunosuppressive agents

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If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting and on FDAs website at the time of the advisory committee meeting