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Specifically, the investigator at Site# 1408 (t:,) (4)) in Study #~J.,4 ) _ _Jwas closed for cause on
October 1, 2012. No notification of the te1mination was sent to the U.S. Food and Drng Administration.
OBSERVATION 2
Records and repo1ts were not retained for two years after marketing application approval and
discontinuance of the investigation and notification of FDA.