Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
SECONDARY
The primary analysis population is the intent-to-treat (ITT) analysis population. The ITT analysis population will consist of all randomized patients in the groups to which they were randomly assigned, and who have taken at least one dose of study treatment.A secondary analysis will be of the adequate adherence (AA) analysis population. The AA analysis population will be the same as the ITT population with the following patients excluded: randomized patients not meeting the eligibility criteria; patients having missed 10 or more doses of their allocated treatment in the first 16 weeks of their treatment.All safety analyses will use the safety analysis population: the safety analysis population will be defined as all patients who received any dose of study medication.After entering the study data into the eCRFs, programmed database checks will raise automatic queries in case of any identified inconsistencies or incompleteness of the data. Further completeness and consistency checks will be performed by data management and any resulting queries will be sent through the database query system so as to leave an audit trail.