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The primary data analysis was by intention to treat, with full analysis of all patients as randomised carried out using multiple imputation datasets with chained equations in Stata version 12; the number of imputed datasets was 20 to align approximately with the proportion of missing data, as is recommended.
Note: Reported statistics are based on pooled results (across multiple imputation datasets).
However, associations were similar in our complete case analyses and analyses based on multivariate multiple imputation datasets (web appendix).
Rubin's multiple imputation method with 30 multiple imputation datasets [ 38] was used together with two contrasting scenarios for the intervention effect in excluded participants.
Note: Reported statistics are based on pooled results (across multiple imputation datasets); CVD cardiovascular disease, ARMHS Australian Rural and Remote Mental Health Study, HCS Hunter Community Study; quality of life impairment scores were standardized using normative means and standard deviations for the physical and psychological HRQoL domains reported in Allen et al. [ 39].
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As mentioned above, the multiple imputation dataset is included for comparison.
Missing covariate data were replaced using multiple imputation (imputed datasets: N=30) applying multivariate chained equations as described for use in the Cox model.
Multiple imputation (10 imputed datasets) was used for missing BMI values.
We applied multiple imputation (five imputed datasets) to baseline variables with missing values (all <5%), using chained equations and all variables in the model.
We first imputed the missing data using mice (multiple imputation algorithm), based on 30 multiple imputed datasets.
MI addresses the limitations of single imputation by using multiple imputed datasets which yield unbiased estimates, and also accounts for the within- and between-dataset variability.
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