LOW RISK Any of the following: · The study protocol is available and all of the study’s pre‐specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way – use trial registration number if available to locate protocol · The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing text of this nature may be uncommon). · The study protocol is not available but authors state that all outcomes are reported.

HIGH RISK Any one of the following: · Not all of the study’s pre‐specified primary and secondary outcomes have been reported · Pre‐specified in methods section · Or pre‐specified in protocol · One or more primary or secondary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre‐specified · One or more reported primary or secondary outcomes were not pre‐specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect) · One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta‐analysis – any data excluded from the analysis despite the data being available (i.e. so the reviewers decided not to include it in the meta‐analysis) · The study report fails to include results for a key outcome that would be expected to have been reported for such a study Outcomes refer in all cases to all study outcomes.

UNCLEAR RISK Insufficient information to permit judgement of ‘Yes’ or ‘No’. · No protocol is available, and no contact can be gained with authors.