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. 2015 Mar 11;2015(3):CD008226. doi: 10.1002/14651858.CD008226.pub3

Sardo 2002.

Methods 4‐Week to 6‐week run‐in period
 12‐week single‐centre randomised placebo‐controlled study
 Randomised 1:1 ratio (atorvastatin:placebo)
 Evening doses
Participants 40 men and women from Italy recruited from a medical centre, mean age 45 years with hypercholesterolaemia; TC > 7.0 mmol/L (271 mg/dL), LDL‐C > 4.1 mmol/L (159 mg/dL), TG < 2.0 mmol/L (177 mg/dL)
Exclusion criteria: arterial HTN, BMI > 27, thyroid disease, renal and hepatic dysfunction, smoking, diabetes, infection, inflammatory or autoimmune disease, arterial and cardiovascular disease
Placebo baseline TC: 7.61 mmol/L (294 mg/dL)
 Placebo baseline LDL‐C: 5.34 mmol/L (206 mg/dL)
 Placebo baseline HDL‐C: 1.38 mmol/L (53 mg/dL)
 Placebo baseline TG: 1.14 mmol/L (101 mg/dL)
Atorvastatin baseline TC: 7.52 mmol/L (291 mg/dL)
 Atorvastatin baseline LDL‐C: 5.41 mmol/L (209 mg/dL)
 Atorvastatin baseline HDL‐C: 1.35 mmol/L (52 mg/dL)
 Atorvastatin baseline TG: 1.17 mmol/L (104 mg/dL)
Interventions Placebo
Atorvastatin 10 mg/d
Outcomes Per cent change from baseline at 4 to 12 weeks of serum TC, LDL‐C, HDL‐C and TG
Notes SDs were imputed
WDAEs were not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information about sequence generation was provided to permit judgement of 'yes' or 'no'
Allocation concealment (selection bias) Unclear risk No information about allocation concealment was provided to permit judgement of 'yes' or 'no'
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk No information about blinding was provided to permit judgement of 'yes' or 'no'
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Data on all participants were reported
Selective reporting (reporting bias) High risk All lipid parameters were measured; WDAEs were not reported
Other bias Unclear risk The source of funding was not provided