42 CHAPTER 2 Confidentiality All clinical and research data collected for this study will be handled in such a way that participant confidentiality is ensured. All digital and hard copy records are kept in (digital) environments with limited access by appropriate staff only. Access rights and responsibilities are recorded on a designated list. Clinical information, images, and research data, will not be used by the study staff for any purposes other than the conduct of the study. Collection, sharing and maintenance of personal information during and after the study will comply with the international and national rules and regulations. Study record retention At the end of the study, all data will be checked and put into a validated database. Following Dutch national legislation, the database will be closed anonymously and stored in the sponsor’s archive for 15 years. Insurance and indemnity The sponsor has a liability insurance and a mandatory participants insurance for medical research involving human participants which is in accordance with the legal requirements in the Netherlands (Article 7 WMO and the Measure regarding Compulsory Insurance for Clinical Research in Humans of 2015). Reporting publications, and notification of results Scientific publications Anonymised results will be published in national and international peer-reviewed journals. Communication and dissemination As the (inter)national expertise centre for NA, the Radboudumc plays a key role in forming treatment guidelines and education of (peripheral) rehabilitation centres and primary care. This position enables rapid transfer of newly emerging knowledge on disease mechanisms and treatment obtained through this trial to the medical community. New treatment modalities, or adjusted or improved rehabilitation programs can therefore be implemented rapidly. Lay-friendly outcomes will be communicated to participants through trial newsletters and with the broader patient population through patient organisations. Where appropriate, information will be disseminated through newsletters, websites and at conferences in collaboration with patient organisations. Authorship policy Data arising from this study will be owned by the trial team and their employer. Authorship of publications coming from this study will follow the research code: publications are submitted only with authors who have made a substantial contribution to the research. Peer review The original proposal for the NA-CONTROL study has been reviewed by external reviewers appointed by the Prinses Beatrix Spierfonds, as part of the funding review process.