Timing of analysis
blindness
BLINDNESS
An initial data exploration is conducted during data collection to ensure the integrity (i.e., the overall completeness and accuracy) of the data stored in the database. No interim analyses are planned. Data preparation, such as data cleaning (e.g., standardizing variable names, encoding categorical variables as factors) and munging will take place for each center after the final visit of the last patient is recorded, as well as plausibility checks. Exploratory data analysis with graphical methods (e.g., histograms, bar-plots, scatterplots, graphical exploration of missing values) will also be conducted for each center after the final visit of the last patient is recorded. The initial and exploratory data analysis, as well as the analysis of the main results, will be carried out by the statistical analysis team [JS, SG, CJ, UN, MSp, ME, NW, LB] with the pseudo-anonymized treatment code, and therefore, treatment blindness will be preserved. The main RCT analyses will include data from patients who have finished their treatment by 19 December 2022. After that date, the data cleaning process will begin. Secondary outcome analysis is planned to occur when the 48-week follow-up period has been reached for participants included in the primary outcome analysis.