Data availability
Data will be shared with bona fide researchers submitting a research proposal requesting access to data for use as approved by the Independent Review Board according to the Independent Review Board Charter (see novonordisk-trials.com). The data will be made available on a specialised SAS data platform. Individual participant data will be shared in data sets in a de-identified/anonymised format. Data sets from Novo Nordisk sponsored clinical research completed after 2001 for product indications approved in both the EU and USA will be shared. Study protocol and redacted Clinical Study Report will be available according to Novo Nordisk data sharing commitments. The data will be available permanently after research completion and approval of product and product use in both the EU and USA. There is no end date.