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

CUSP 2009.

Methods Individual‐level RCT
Participants 130 participants (66 intervention; 64 comparator) from the USA with coexisting, untreated hypertension (SBP = 140 mmHg‐169 mmHg or DBP = 90 mmHg‐105 mmHg) and dyslipidaemia (LDL‐C = 110 mg/dL‐160 mg/dL) but without a history of cardiovascular disease; age > 21 years
Interventions Intervention: single pill amlodipine/atorvastatin (5 mg/20 mg) + therapeutic lifestyle changes
Comparator: therapeutic lifestyle changes
Outcomes Target for BP < 140/90 mm Hg and LDL‐C < 100 mg/dL (2.59 mmol ⁄L) at week 4 and week 8: the percentage of participants in whom the single LDL‐C goal was reached at weeks 4 and 8; mean changes from baseline in SBP and DBP at weeks 4 and 8; mean changes from baseline in LDL‐C at weeks 4 and 8; 10‐year Framingham risk of CHD at weeks 4 and 8
Notes Comparator: inactive/usual care
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specifically stated: "Patients were randomised in a double‐blind manner"
Allocation concealment (selection bias) Unclear risk Not specifically stated
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not specifically stated
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not specifically stated
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Unclear how data from participants lost to follow‐up were handled
Selective reporting (reporting bias) Low risk Primary outcomes reported (week 4 blood pressure and LDL targets)
Other bias Low risk No other sources of bias are identifiable