Article History
Received: 16 October 2017
Accepted: 19 July 2018
First Online: 6 August 2018
Ethics approval and consent to participate
: Each participating site in the original PROGNOSIS study provided Ethics Committee/Institutional Review Board approval of the study protocol and associated documents (participant informed consent, participant information) before the start of the clinical part of the study. All women provided written informed consent before enrollment (26, 27; Additional file InternalRef removed). Ethics approval and participant consent for this health economic analysis for Germany was not necessary as this study involved the use of a previously published de-identified database of PROGNOSIS according to German legislation.
: Not applicable (no data from an individual person).
: Martin Hund, Cyrill Wolf and Annabel Schroer are employees of Roche Diagnostics.Dietmar Schlembach has provided counselling services to Roche and has received fees from Roche for lectures.
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