Corti 2005.

Study characteristics
Methods	Study design: prospective, randomised, double‐blind trial Total duration of study: 3 years Details of any 'run‐in' period: no details given Number of study centres and location: 1 centre, Mount Sinai School of Medicine, New York Study setting and date of study: outpatients; March 1999 to 2002
Participants	Number randomised: 51 participants Number lost to follow‐up/withdrawn: "one patient was lost to follow‐up during the first 6 months: a 52‐year‐old man with no previous episode of angina died suddenly during exercise 3 weeks after starting in the conventional treatment group." Number analysed: 51 participants Number of interest: 51 participants Mean age: 62 years Age range: 41.4 to 82.9 years Gender: 31 men and 20 women Severity of condition: clinically asymptomatic patients​​​​​​​ Diagnostic criteria: "hypercholesteraemic (LDL 130 mg/dL and triglycerides 445 mg/dL)" Smoking history: 16 previous smokers and 15 current smokers Inclusion criteria: "based on the pre‐existence of atherosclerotic plaques (thoracic aortic wall 4.0 mm and/or carotid wall 2.0 mm thick) detected by carotid B‐mode ultrasound, echocardiography, or MRI" Exclusion criteria: "heart failure, renal or hepatic disease, significant carotid disease, or a clinically significant medical or surgical event within 3 months before study entry"
Interventions	Intervention: simvastatin 80 mg Comparison: simvastatin 20 mg Concomitant medications: no details given Excluded medications: no details given
Outcomes	Primary outcome: "change in vessel wall area (VWA) as a surrogate for atherosclerotic burden" Secondary outcomes: no details given Time points reported: "clinical follow‐up was done at 6, 12, 24, and 48 weeks and blood samples were drawn at baseline, 6, 12, 24, 48, 72, and 96 weeks to determine lipid levels and safety parameters."
Notes	Funding for trial: "this study was supported by grants from the National Institutes of Health (HL54469, Drs Fuster and Badimon); the National Heart, Lung, and Blood Institute (HL61801, Dr Fuster); the Swiss National Research Foundation (Dr Corti); the National Heart Foundation of Australia (Dr Worthley); the French Federation of Cardiology (Dr Helft); and Merck and Co, Inc. Merck and Co. was partially responsible for the funding of the project." Notable conflicts of interest of trial authors: Mount Sinai authors are fully responsible for data acquisition, evaluation, and writing the manuscript without any interference from the funding sources Protocol: no details given
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "A Prospective, Randomized, Double‐Blind Trial"
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not reported
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The measurements were performed blinded to the patient’s identity and image order."
Incomplete outcome data (attrition bias) All outcomes	Low risk	All outcome measures have been reported in the results section
Selective reporting (reporting bias)	Low risk	All prespecified outcomes reported
Other bias	Low risk	No other source of bias detected