Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
EVENT, SECONDARY
No missing data will be accepted for the primary endpoint and the main analysis will be based on patients with no missing data. In the event of isolated ALT or AST missing data for the primary endpoint, these data will be replaced by imputation on a case-by-case basis and this new dataset will be analyzed as a supplementary analysis. The imputation will be performed blindly by the methodologist together with the principal investigator and will be validated by the DSMB. In the event of missing or invalid data for secondary endpoints, the principal investigator and the person in charge of data analysis will decide whether these data should be considered as missing or replaced by imputation.