Availability of data and materials
To ensure independent interpretation of the clinical study results, Boehringer Ingelheim grants all external authors access to relevant material, including participant-level clinical study data, as needed by them to fulfill their role and obligations as authors under the ICMJE criteria.Clinical study documents and participant clinical study data are available to be shared on request after the publication of the primary manuscript in a peer-reviewed journal and if regulatory activities are complete and other criteria met as per the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data (see Researchers should use the 