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. 2017 Mar 6;2017(3):CD009868. doi: 10.1002/14651858.CD009868.pub3

Wald 2012.

Methods Individual‐level randomised double‐blind placebo‐controlled cross‐over trial
Participants 86 individuals (43 Polypill then placebo; 43 placebo then Polypill) aged 50 years or over without history of cardiovascular disease who were previously taking simvastatin and blood pressure‐lowering drugs; limited to participants living in London or could travel easily to London
Interventions Intervention: fixed‐dose combination (amlodipine 2.5mg, losartan 25mg, hydrochlorothiazide 12.5mg, simvastatin 40mg) daily for 12 weeks
Comparator: placebo
Outcomes SBP, DBP, total cholesterol, LDL‐C, HDL‐C, triglycerides, apoB, adherence (pill counts of fixed‐dose combination compared with placebo), adverse events
Notes Comparator: inactive/placebo
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated block randomisation
Allocation concealment (selection bias) Low risk Computer‐generated block randomisation with sequential identical blister packs
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Placebo controlled
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcome assessors reported as being blinded
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Primary outcomes reported
Selective reporting (reporting bias) Unclear risk Adverse event data not clearly described; only proportion of individuals with "symptom", which was assumed to be an adverse event
Other bias Low risk No need for intention‐to‐treat analysis as cross‐over design. Any losses to follow‐up clear

apoB: apolipoprotein B
 CHD: coronary heart disease
 CVD: cardiovascular disease
 DBP: diastolic blood pressure
 ECG: electrocardiogram
 HDL‐C: high‐density lipoprotein cholesterol
 LDL‐C: low‐density lipoprotein cholesterol
 PVD: peripheral vascular disease
 RCT: randomised controlled trial
 SBP: systolic blood pressure