Blanco‐Colio 2004.

Study characteristics
Methods	Study design: randomised, double‐blinded, multicentre study Total duration of study: 4 to 6 weeks Details of any 'run‐in' period: 6‐week run‐in period of placebo treatment Number of study centres and location: 1 centre, Hospital Clínico San Carlos, Madrid, Spain Study setting and date of study: outpatients; date of study was not reported
Participants	Number randomised: 14 participants Number lost to follow‐up/withdrawn: no detail given Number analysed: 14 participants Number of interest: 14 participants Mean age: 71.5 +/‐ 6 years in atorvastatin group and 68.6 +/‐ 9 years in "no treatment" group Age range: 18 to 80 years Gender: 10 men and 4 women Severity of condition: "carotid atherosclerosis (carotid stenosis > 70%, as diagnosed by Doppler echocardiography)" Diagnostic criteria: "normocholesterolemic patients with carotid atherosclerosis (carotid stenosis > 70%, as diagnosed by Doppler echocardiography) and without previous statin therapy" Smoking history: 1 smoker Inclusion criteria: "participants were included in the trial if, after discontinuation of any lipid‐regulating drug, formal dietary counselling, good compliance with the prescribed diet, and a six‐week run‐in period of placebo treatment, they had a mean (of 2 consecutive analyses at weeks 4 and 2) triglyceride level of < 500 and > 200 mg/dL, respectively, in addition to LDL cholesterol < 250 and > 190, 180, 160, or 135 mg/dL, depending on the global risk status (low, moderate, high, or presence of coronary heart disease, respectively), according to the European Atherosclerosis Society (EAS) recommendations" Exclusion criteria: "people were excluded from the trial if they were pregnant or nursing, had an inflammatory disease or tumour, or had been treated with hypolipaemic or anti‐inflammatory drugs (except aspirin < 325 mg/day) during the year preceding the study. Patients must not have had a myocardial infarction, angioplasty, severe or unstable angina pectoris, or any other cardiovascular event resulting in hospitalisations during the six months preceding the study."
Interventions	Intervention: 80 mg/day atorvastatin Comparison: no treatment Concomitant medications: no details given Excluded medications: hypolipaemic or anti‐inflammatory drugs
Outcomes	Primary outcome: sFasL levels in participants with clinical atherosclerosis without marked hyperlipidaemia Secondary outcome: adverse events Time points reported: no details given
Notes	Funding for trial: this study was supported by grants from the Ministerio de Ciencia y Tecnología (SAF 2001‐0717), the Spanish Cardiovascular Network (03/01), the Fundación Ramón Areces, and Pfizer, Madrid, Spain. Notable conflicts of interest of trial authors: "Josep M Sol, Cristina Díaz, and Gonzalo Hernández are employees of Pfizer. They were engaged in the design and recruitment of patients included in the ATOMIX study (Atorvastatin versus Bezafibrate in Mixed Hyperlipidaemia: Randomised Clinical Trial of Efficacy and Safety) from which we took the samples. Therefore, although they are employees of Pfizer, they have no particular conflict of interest with the content of this paper. Drs. Blanco‐Colio and Martín‐Ventura contributed equally to this work." Protocol: no details given
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The lipid values of randomized patients were kept unknown to both the patient and the investigator until the end of the study."
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported
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