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. 2018 Nov 19;2018(11):CD012502. doi: 10.1002/14651858.CD012502.pub2

Kodali 2011.

Methods Design: RCT
Number of study centres: not reported, USA
Setting: not reported
Patient recruitment: not reported
Duration of study (Follow‐up): 12 months
Clinical setting: 'statin naive' patients with maximum carotid stenosis > 50%
Participants Enrolment (N): 18
Randomised (N): not reported
Withdrawn (N): not reported
Lost to follow‐up (N): not reported
Completed the study (N): not reported
Analysed (N): not reported
Age (years) (mean ± SD): not reported
Sex (male, N, %): not reported
Smoking history (N, %): not reported
BMI (kg/m², mean ± SD):): not reported
Diabetes (N, %): not reported
Hypertension (N, %): not reported
History of CHD (N, %): not reported
Statin pretreatment (N, %): intervention:0% ; control:0%
Inclusion criteria: 'statin naive' patients with maximum carotid stenosis > 50%
Exclusion criteria: not reported
Interventions Intervention: ezetimibe 10 mg/ simvastatin 40 mg
Comparison: simvastatin 40 mg
Details of any 'run‐in' period: not reported
Concomitant medications: not reported
Excluded medications: not reported
Outcomes Primary: changes in carotid outer wall area (OWA), lumen area (LA), vessel wall area (VWA), lipid area (LpA) and lipid percentage (Lp%), measured by high‐resolution CMR
Notes Two conference abstracts only.
 No outcome data relevant to this review.
 Emailed trialists for details. No response
 Source of funding: not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomized", but no further details.
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Not reported
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias High risk Published conference abstract only