Sposito 2003.

Methods	No lipid‐lowering therapy in the 6 months preceding the study 3‐Month dietary stabilisation period 6‐Week randomised placebo‐controlled trial
Participants	45 men and women aged 30 to 76 years; LDL‐C > 100 mg/dL (2.59 mmol/L), TG < 400 mg/dL (4.52 mmol/L) Exclusion criteria: premenopausal women, diabetes mellitus, alcohol abuse; liver, renal and thyroid disease; cancer Placebo baseline TC: 6.34 mmol/L (245 mg/dL) Placebo baseline LDL‐C: 4.34 mmol/L (168 mg/dL) Placebo baseline HDL‐C: 0.98 mmol/L (38 mg/dL) Placebo baseline TG: 2.28 mmol/L (202 mg/dL) Atorvastatin 10 mg/d baseline TC: 6.49 mmol/L (251 mg/dL) Atorvastatin 10 mg/d baseline LDL‐C: 4.37 mmol/L (169 mg/dL) Atorvastatin 10 mg/d baseline HDL‐C: 0.98 mmol/L (38 mg/dL) Atorvastatin 10 mg/d baseline TG: 2.37 mmol/L (210 mg/dL) Atorvastatin 40 mg/d baseline TC: 6.00 mmol/L (232 mg/dL) Atorvastatin 40 mg/d baseline LDL‐C: 4.40 mmol/L (170 mg/dL) Atorvastatin 40 mg/d baseline HDL‐C: 0.91 mmol/L (35 mg/dL) Atorvastatin 40 mg/d baseline TG: 2.18 mmol/L (193 mg/dL)
Interventions	Placebo Atorvastatin 10 mg/d Atorvastatin 40 mg/d
Outcomes	Per cent change from baseline at 6 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	Low risk	The study appears to be free of other sources of bias