Attachment 1. Product Information for Atozet/Zeteze
There were 4 deaths in the short term studies; 2 in the ezetimibe + atorvastatin group and one further death in a long term study. None was considered treatment related. The exposure adjusted SAE rate (per 100 patient years) in the short term studies (12.3) was mildly higher than atorvastatin (9.6). ................
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