Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data
Since the study is designed as a non-inferiority study, the primary analysis will be carried out by considering all evaluable patients (per-protocol population), as this is the most conservative approach in this context. A patient will be considered as evaluable if the treatment and the follow-up conform to the study protocol (diagnostic tests performed) and if the patient does not have detectable anti-Tg antibodies. A sensitivity analysis using the intent-to-treat (ITT) population, considering all patients in their initial group of randomization, will also be performed, to test the robustness of the results.