ABSTRACT

This is to notify you that the study listed above is completed at this site. The last subject has completed hislher last study evaluation. No additional subjects will be enrolled. The following information is pertinent concerning the study:

Enrollment Number of subjects screened Number of drop-outs Number of subject enrolled Number of subject completed

Summary of SAEs

Summarv of GCP Violations Subject Subject Initials Number GCP Violation

If you have any questions concerning the information in this report, please contact me at (phone number)

Principal Investigator (print) Investigator's Signature Date