300 Appendices Section/Topic Item No Checklist item Reported on page No Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Study protocol (Swinkels et al. 2020) Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NA 11b If relevant, description of the similarity of interventions NA Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 140-141 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses 141 Results Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome Figure 1 13b For each group, losses and exclusions after randomisation, together with reasons Figure 1 Recruitment 14a Dates defining the periods of recruitment and follow-up 133 14b Why the trial ended or was stopped NA Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Table 1 Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Table 2
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