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To identify, appraise and synthesise studies evaluating the downsides of wearing face masks in any setting. We also discuss potential strategies to mitigate these downsides. Systematic review and meta-analysis. PubMed, Embase, CENTRAL and EuropePMC were searched (inception-18 May 202, and clinical registries were searched via CENTRAL. We also did a forward-backward citation search of the included studies. We included randomised controlled trials and observational studies comparing face mask use to any active intervention or to control