Statistical Analysis
diabetes
REGRESSION, SECONDARY, DIABETES
Using 20-week data from the Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management (SCALE) trial,The statistical analysis plan was finalized prior to database lock (February 5, 2021). The primary analyses estimated the difference in mean percentage body weight change between patients randomized to liraglutide vs placebo using a linear regression model adjusting for baseline weight, type of surgery, and diabetes status. This analysis was carried out by comparing the intervention and control groups as randomized using all available data (intention-to-treat). Additionally, a per-protocol analysis was carried out for the primary outcome as part of the secondary analyses. Linear and logistic regression models adjusting for baseline values of the outcomes where available and type of surgery and diabetes status were used to analyze the secondary outcomes. Random-effects models were used to analyze the repeated measures of the primary and secondary outcomes as part of the secondary analyses. The normality assumption was checked for each model using residual plots. If violated, a suitable transformation or nonparametric method was considered. All secondary analyses were carried out on an intention-to-treat basis. A sensitivity analysis was also carried out by replacing the missing clinic weight values by the self-reported ones for the primary outcome. A significance level of .05 was used for all hypothesis testing. 