Reporting of study results
Upon completion of the clinical trial, or in case of early termination of the trial, a clinical study report will be prepared no later than 12 months after study end. The report will be written by the sponsor after trial data have been cleaned/verified and the database has been locked. Only the project management team at the sponsor and Excelya Germany GmbH (for statistical analysis) will have access to the final trial dataset. Investigators do not have global access to the eCRF data and will not be granted access to the full dataset once the trial is over.Additionally, as per EU Commission Guideline 2012/C 302/03, study results will be entered into the EudraCT database for publication in the EU Clinical Trials Register.