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The implications of non‐compliance

An intention-to-treat (ITT) analysis measures the effect of offering a treatment, not necessarily the effect of receiving that treatment. Performing ITT analysis provides an estimate of the treatment effect under real-world circumstances where there is likely to be non-compliance (effectiveness). By contrast, a per-protocol analysis is used to assess how the treatment would work under the ideal condition that all participants perfectly complied with their treatment allocation (efficacy). However, per-protocol analyses can be compromised, as they may not retain the randomisation.