PILL 2011.

Methods	Individual-level randomised controlled trial
Participants	378 participants (189 intervention; 189 control) with 5-year Framingham coronary heart disease risk ≥7.5% or if Framingham risk was between 5% and 7.5%, two or more additional untreated risk factors were needed (body mass index >30kg/m2, waist circumference > 102cm in men or >88cm in women; heart rate > 80 bpm; fasting glucose 5.6-7 mmol/L, triglycerides >1.7 mmol/L; family history of first degree relative with premature ischemic heart disease or stroke (men < 55 years; women: <65 years), or glomerular filtration rate <60ml/min
Interventions	Intervention: Red heart pill (aspirin 75 mg, lisinopril 10mg, hydrochlorothiazide 12. 5mg and simvastatin 20mg) Control: placebo
Outcomes	Change in SBP; change in LDL-C; tolerability; secondary outcomes included adherence, DBP, total cholesterol, HDL-C, total cholesterol:HDL cholesterol ratio, non-HDL cholesterol, triglycerides, frequency of switching/adding open-label treatment, estimated effects on CVD risk
Notes	Control: inactive/placebo
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Central computer based randomisation
Allocation concealment (selection bias)	Low risk	Central computer based randomisation
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Specifically reported and use of placebo control
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors and study staff all blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Low rates of loss to follow-up (experimental 2%; control 1%)
Selective reporting (reporting bias)	High risk	Last observation carried forward for missing data at week 12