tabulation of all treatment-emergent adverse events (Appendix 4.2.2}.1 DOSAGE AND ADMINISTRATION/Switching from Other Antipsychotics The sponsor has added, as the first paragraph, some general guidance to prescribers regarding switching patients from other antipsychotics to aripiprazole. This language is very similar to that currently found in Seroquel labeling and is not objectionable. However, they also propose to ' - E. Safety Update The sponsor has provided a Safety Update with a cut-off

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... e of 6-30-02. The cut-off date for the 120-Day Safety Update, which was incorporated into the original clinical review, was 11-30-01. Since the last update, 882 new patients received aripiprazole in non-Japanese Phase 2/3 studies as well as 59 new patients in non-Japanese Phase 1 trials and 55 new subjects in Japanese studies. As of 6-30-02, a total of 5,592 patients have been exposed to aripiprazole in non-Japanese Phase 2/3 studies. There are no new safety data from short-term, placebocontrolled studies in patients with schizophrenia. The review of this update focused on serious adverse events (SAE's), includin~_ deaths, in the non-Japanese Phase 2/3 studies. There were no new SAE's in the non-Japanese Phase 1 studies-~r in the Japanese studies.