Jautová, Jagienka
Zelenková, Hana
Drotarová, Katarína
Nejdková, Alena
Grünwaldová, Božena
Hladiková, Marie
Article History
Received: 7 March 2018
Accepted: 5 October 2018
First Online: 7 November 2018
Compliance with ethical guidelines
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: J. Jautová, H. Zelenková, K. Drotarová, A. Nejdková, B. Grünwaldová, and M. Hladiková declare that they have no competing interests.
: The study was registered under EudraCT No. 2012-004372-19 and performed in accordance with the Declaration of Helsinki/Edinburgh and followed ICH-GCP guidelines. Agreement from all ethics committees presiding over the trial centers was obtained. The acceptance of the relevant state authorities (SUKL in Bratislava [Slovakian Drug Authorization Authority]) was also obtained. Written consent was obtained from all patients after information.