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. 2021 Sep 2;2021(9):CD013825. doi: 10.1002/14651858.CD013825.pub2

Risk of bias for analysis 1.6 Serious 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
BLAZE‐1 (phase 2, 0.7g) Low risk of bias Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation. Low risk of bias Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate. Low risk of bias Data for this outcome was available for 257 out of 265 participants randomised. Low risk of bias The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received. Low risk of bias The data that produced this result was analysed in accordance with the pre‐specified analysis plan and the outcome was reported as planned in the protocol. Low risk of bias For this outcome, there is a low risk of bias for all the domains.
BLAZE‐1 (phase 2, 2.8g) Low risk of bias Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation. Low risk of bias Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate. Low risk of bias Data for this outcome was available for 263 out of 270 participants randomised. Low risk of bias The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received. Low risk of bias The data that produced this result was analysed in accordance with the pre‐specified analysis plan and the outcome was reported as planned in the protocol. Low risk of bias For this outcome, there is a low risk of bias for all the domains.
BLAZE‐1 (phase 2, 7.0g) Low risk of bias Participants were randomised via an Interactive Web Response System (IWRS) and the allocation sequence was concealed. There are no baseline differences that would suggest a problem with randomisation. Low risk of bias Both participants and those delivering the intervention were unaware of the assigned intervention received and the analysis was appropriate. Low risk of bias Data for this outcome was available for 257 out of 265 participants randomised. Low risk of bias The measurement of the outcome was appropriate and it is unlikely that it differed between intervention groups. The outcome assessors were unaware of the intervention received. Low risk of bias The data that produced this result was analysed in accordance with the pre‐specified analysis plan and the outcome was reported as planned in the protocol. Low risk of bias For this outcome, there is a low risk of bias for all the domains.