Methods
ICH
INOVATYON was an open-label, international, parallel-group, randomised phase 3 trial conducted at 117 centres in 11 European countries. The trial was overseen by an independent data monitoring committee (IDMC) and a steering committee. The trial was done in accordance with the Declaration of Helsinki and the International Conference on Harmonisation (ICH) E6 Guidelines for Good Clinical Practice. The trial was approved in each country by the competent authority (CA), a central independent ethics committee and by the independent ethics committees at each trial site. All patients provided written informed consent to participate. The study was performed according to the ENGOT Model A [