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. 2022 Mar 9;2022(3):CD015125. doi: 10.1002/14651858.CD015125

Risk of bias for analysis 1.8 Adverse events.

Study Bias
Randomisation process Deviations from intended interventions Missing outcome data Measurement of the outcome Selection of the reported results Overall
Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement Authors' judgement Support for judgement
Clemency 2021 Low risk of bias We judged this domain low as the randomisation process was adequate because it is done remotely and moreover consider concealment adequate. Slight baseline differences were most likely due to chance. Low risk of bias Deviations were balanced and most likely not due to the trial context in this double‐blinded trial. Low risk of bias Some adverse events lead to trial discontinuation. But they had been reported, so we do not assume, that the ~5% "lost to follow up" affected the outcome. Low risk of bias We judged low risk of bias, as the combination of structured contacts and eDiary provided a high probability that the outcome would have been detected. Low risk of bias We judged this domain low due to pre‐specification of the outcome. Low risk of bias Overall, we judged low risk of bias.