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

Soliman 2009.

Methods Open label, parallel‐group RCT
Participants 216 participants (105 polypill; 111 comparator); ≥ 40 years for men and ≥ 50 years for women; estimated 10‐year World Health Organization total cardiovascular risk score ≥ 20% without established cardiovascular disease
Interventions Intervention: Red Heart pill 2b (75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide)
Comparator: standard practice defined by the study investigators
Outcomes SBP, total cholesterol, 10‐year cardiovascular disease risk, adherence, fasting glucose, creatinine, potassium, and liver enzymes
Notes Comparator: inactive/usual care
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No method of randomisation stated
Allocation concealment (selection bias) Unclear risk No method of randomisation stated
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open label
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open label
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear how missing data were handled
Selective reporting (reporting bias) Low risk Primary outcomes (blood pressure, cholesterol, ten year CVD risk) all reported
Other bias High risk Use of non‐study antihypertensives and statins very different between centres