Ethics statement
The study was conducted in accordance with the Declaration of Helsinki and the EU guidelines on Good Clinical Practice for conducting clinical trials of medicines; the study was approved by the Ethics Review Committee/Institutional Review Board of the Coordinating Center and by the Ethics Committees of each individual participating center of TOSCA.IT (Thiazolidinediones Or Sulphonylureas and Cardiovascular Accidents. Intervention Trial) Trial, registered at ClinicalTrials.gov as NCT00700856 (