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). ................
................