Methods
ICH
The analysis outlined in this document is in full compliance with International Conference on Harmonisation ICH E9 guidance [The SAP (version 2.0 of April 05, 2023) is an update of SAP version 1.3 dated 23 July 2019 and includes the sample size reassessment and additional analyses to account for the COVID-19 pandemic, in alignment with the most recent protocol (version 2.0, 23 July 2021). The SAP has been finalized prior to the completion of the data collection. The study protocol has been registered at 