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Treatment allocation was masked for participants, clinicians and those evaluating outcomes until after database lock.
After 6 weeks of placebo run-in, participants were randomly assigned to receive the main comparison of simvastatin (20 mg) plus ezetimibe (10 mg) as a single tablet versus matching placebo versus simvastatin (20 mg) alone in a ratio of 4 4 1, and treatment allocation was masked using a double-dummy method.
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Participants were assessed at baseline by the recruiting researcher and at 12 months after randomisation by a separate researcher who was masked to allocation status.
The analyses were carried out by a statistician who was masked to group allocation, using SAS 9.1.
The follow-up examinations were by a single observer, but it is unclear if he was masked to the allocation.
Major outcome events were submitted to an independent external adjudicator, who was masked to treatment allocation and who determined the cause, severity, and duration of the event.
Children were recruited in the summer term prior to randomisation except for the 3-year-old children entering school in September who were screened and recruited after randomisation by a researcher who was masked to group allocation.
The data analyst was masked to the cluster allocation until analysis was complete.
The investigator was masked for time assessment and group allocation.
Research assessors and supervising staff were blind to treatment allocation but allocation could not be masked from therapists or families.
Because the two treatment methods studied were quite different (tablet vs injection), the treatment allocation could not be masked from the investigators or patients.
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