 Solution

Use a concurrent randomized comparison of the new leaflet with the existing release information. Random allocation makes the groups comparable in expectation and avoids attributing a secular change in drug supply, release populations or post-release services to the leaflet. Both arms should use the same outcome ascertainment and two-week follow-up. This improves the causal interpretation over a historical before-and-after comparison; adequate sample size remains necessary given the low statistical power calculated above. If contamination prevents individual allocation, a carefully designed cluster randomized controlled trial is an alternative, with its sample-size calculation allowing for within-cluster dependence.