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Authors
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van Ommen-Nijhof, A.
Konings, I. R.
van Zeijl, C. J. J.
Uyl-de Groot, C. A.
van der Noort, V.
Jager, A.
Sonke, G. S.
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Funding
Funding for this research was provided by:
ZonMw (848050008)
Zorgverzekeraars Nederland (GB 2537)
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Article History
Received: 23 March 2018
Accepted: 21 October 2018
First Online: 20 November 2018
Ethics approval and consent to participate
: The SONIA study was approved by the accredited Medical Ethics Committee of the Netherlands Cancer Institute – Antoni van Leeuwenhoek (METC AVL) on September 29th, 2017. Ethical approval was obtained for all clinical sites, a list of sites currently open for inclusion can be found on (NCT03425838). The study will be conducted in accordance with legal and regulatory requirements, as well as the general principles set forth in the International Ethical Guidelines for Biomedical Research Involving Human Subjects, Guidelines for good Clinical Practice (GCP), and the Declaration of Helsinki. All patients must provide written informed consent.
: Not applicable.
: GSS is a member of the steering committee of the MONALEESA-2 trial and national principal investigator for the MONALEESA-3 trial. In addition he reports institutional research support form AstraZeneca, Merck, Novartis, and Roche. No other competing interests have been reported.
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