Statistical analyses Trial profile The flow of study participants will be displayed in a Consolidated Standards of Reporting Trials (CONSORT) diagram at a cluster level and at individual level. The number of clusters fulfilling the inclusion criterion and the number of clusters included in primary and secondary analyses will be presented. The number of patients who fulfilled study inclusion criteria as well as the number included in the primary and secondary analyses will be reported. Reasons for exclusions of clusters and patients in the primary and secondary analyses will be reported.