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. 2016 Mar 10;2016(3):MR000043. doi: 10.1002/14651858.MR000043.pub2

BIP 2000.

Methods RCT comparing bezafibrate versus placebo in patients with coronary artery disease.
Data 3122 patients were randomised (1542/1558, respectively in each treatment group), 32 patients were excluded from analysis because they never started the study medication.
Comparisons Onsite assessment (local investigator blinded) versus assessment by an AC blinded to allocated treatment.
Outcomes The outcome selected was fatal or non fatal myocardial infarction or sudden death. The study's primary outcome was time to one these events.
Notes Data related to the number of events in each treatment group resulting from onsite‐assessment were obtained directly from the study authors.
Risk of bias
Item Authors' judgement Description
Method for selecting cases to adjudicate? No All suspect events adjudicated were identified by onsite assessor who was blinded to allocated treatment.