Recipient: Ronald G. Crystal M.D.
Product: Investigational biologic products
Date: 9/23/02

Subject _____ was enrolled in the study without Computerized Tomography (CT) documentation of the number of _____ present at the time of enrollment. Section 3.2 of the protocol requires that the subject have two or more _____ detected by CT scan.

Issuer: Center for Biologics Evaluation and Research (CBER)