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

TOGETHER 2010.

Methods Individual‐level randomised, double dummy controlled trial
Participants 244 participants (122 intervention; 122 control) from the USA with history of hypertension but no history of CVD or diabetes with ≥ 2 risk factors: age ≥ 45 years for men; ≥ 55 years for women; current smoker; family history of premature coronary heart disease in first degree relative; HDL cholesterol < 40 mg/dl; waist circumference > 102 cm in men and > 88 cm in women
Interventions Intervention: single pill amlodipine (5/10 mg) plus atorvastatin 20 mg + therapeutic lifestyle changes
Comparator: amlodipine (5/10 mg) + therapeutic lifestyle changes
Outcomes Proportion achieving a BP goal < 140/90 mmHg and LDL‐C < 100 mg/dl at week 6; BP and LDL‐C goal at week 4; BP goal at weeks 4 and 6; change in SBP, DBP, LDL‐C, total cholesterol, HDL‐C, triglycerides at weeks 4 and 6; predicted 10‐year Framingham coronary heart disease risk score, adverse events
Notes Comparator: active
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Central, computer‐based telerandomisation
Allocation concealment (selection bias) Low risk Central, computer‐based telerandomisation
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind labelled bottles and double dummy
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Reportedly double blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk Last observation carried forward used for non‐completers for final analysis
Selective reporting (reporting bias) Unclear risk Primary outcomes reported
Other bias Low risk No other sources of bias are identifiable