Methodology for UK recruitment into a large-scale international clinical trial

Methods Ethics and Section 251 of the Health and Social Care Act approval allowed potentially eligible patients to be identified (without consent) from local site’s hospital records and invited by a central coordinating office to a local screening appointment. Following a screening visit and initial run-in phase to standardise background LDL-cholesterol management, those remaining eligible entered an active ERN/LRPT run-in to assess their tolerance of the drug and likely long-term compliance. Participants, if still eligible, were then randomized to ERN/LRPT or placebo.