CRUCIAL 2011.

Methods	Open label, cluster‐randomised trial
Participants	136 clusters; 1461 total participants (779 intervention; 682 comparator participants) from 19 countries (Costa Rica, Croatia, Czech Republic, Dominican Republic, Indonesia, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Panama, Philippines, South Korea, Russia, Taiwan, Thailand, Turkey, United Arab Emirates, Venezuela) Men and women aged 35‐79 years with hypertension and total cholesterol < 250 mg/dL plus 3 or more risk factors (current smoker, peripheral artery disease, type 2 diabetes, family history of early CHD before aged 55 years in first‐degree relative; left ventricular hypertrophy on ECG; history of transient ischaemic attack or stroke three or more months prior to screening; ECG abnormalities; age > 55 years (men) or > 65 years (women), total cholesterol > 250mg/dL, or HDL < 40mg/dL)
Interventions	Intervention: single pill amlodipine/atorvastatin (5 mg/10 mg‐10 mg/10 mg; site investigators could request dosages of 5/20 mg and 10/20 mg) in addition to other hypertensive/lipid‐lowering therapy as required, as well as therapeutic lifestyle counselling change Comparator: usual care, including therapeutic lifestyle counselling change
Outcomes	SBP, DBP, LDL‐C, total cholesterol; all‐cause mortality reported
Notes	Comparator: inactive/usual care
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Investigators ‐ randomly assigned", "randomisation was stratified", "investigator as unit of randomisation"
Allocation concealment (selection bias)	Unclear risk	Due to cluster randomisation
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	High risk	93/779 (11.9%) discontinued intervention; 44/682 (6.5%) discontinued in usual care arm
Selective reporting (reporting bias)	Unclear risk	Not all outcomes available for meta‐analysis
Other bias	Unclear risk	Differences between two arms in terms of baseline blood pressure, ECG abnormalities, PVD