Manzini, G. https://orcid.org/0000-0002-8032-8043
Ettrich, T. J.
Kremer, M.
Kornmann, M.
Henne-Bruns, D.
Eikema, D. A.
Schlattmann, P.
de Wreede, L. C.
Article History
Received: 11 January 2018
Accepted: 16 January 2018
First Online: 13 February 2018
Ethics approval and consent to participate
: Not applicable. For the present analysis the original data set of the FOGT-2 trial was used. This set is stored in anonymous form at the Clinic of General and Visceral Surgery and is readily available for access as Excel table. Data are fully available upon request. One of the co-authors of the present study and first author of the primary publication (Kornmann M, Staib L, Wiegel T, Kreuser ED, Kron M, Baumann W, Henne-Bruns D, Link KH. Adjuvant chemoradiotherapy of advanced resectable rectal cancer: results of a randomised trial comparing modulation of 5-fluorouracil with folinic acid or with interferon-α. Br J Cancer. 2010 Oct 12;103(8):1163–72) is responsible for maintainance, performance, and evaluation of subgroup analysis. The original study (FOGT-2) was carried out conform to the International Conference on Harmonisation/WHO Good clinical practice and was approved by the Ethics Committee of the University of Ulm (#87/91). All patients gave informed consent to participate, were informed and agreed to subsequent anonymous data analysis. Therefore no additional ethics approval was required for the present evaluation.
: Not applicable for the same reason as explained in “ethics approval and consent to participate”.
: The authors declare that they have no competing interests.
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