In the event of the inclusion of cluster-randomized trials, we will take appropriate measures to avoid unit-of-analysis errors when reporting their findings and/or incorporating them into meta-analysis [128]. When available, we will use the intracluster correlation coefficient (ICC) reported in the trial to apply a design effect to the sample size and number of events in each of the treatment and control groups [129]. If not reported, we will use an external estimate from similar studies. We will clearly identify cluster-randomized trial data when it is included in meta-analysis with individually randomized trials. Decisions about whether it is reasonable to pool data from cluster-randomized and individually randomized trials will be undertaken on a case-by-case basis. We will investigate the robustness of the conclusions from any meta-analysis including cluster-randomized trials via sensitivity analysis.

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