Wiland, Piotr
Jeka, Sławomir
Dokoupilová, Eva
Brandt-Jürgens, Jan
Miranda Limón, Juan Manuel
Cantalejo Moreira, Miguel
Cabello, Raul Veiga
Jauch-Lembach, Julia
Thakur, Anjali
Haliduola, Halimuniyazi
Brueckmann, Ines
Gaylis, Norman B.
Funding for this research was provided by:
Hexal AG, a Sandoz company
Article History
First Online: 29 October 2020
Declarations
:
: This study was funded by Hexal AG, a Sandoz company.
: Piotr Wiland: None declared. Sławomir Jeka: None declared. Eva Dokoupilová: Research grants from AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Sanofi-Aventis and Hexal AG. Jan Brandt-Jürgens: None declared. Juan Manuel Miranda Limón: None declared. Miguel Cantalejo Moreira: None declared. Raul Veiga Cabello: None declared. Julia Jauch-Lembach: Employee of Sandoz. Anjali Thakur: Employee of Sandoz. Halimuniyazi Haliduola: Employee of Sandoz. Ines Brueckmann: Employee of Sandoz. Norman B. Gaylis: None declared.
: The study was conducted in accordance with the ethical principles derived from the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practices and in compliance with local regulatory requirements. The study protocols were approved by the Independent Ethics Committee or Institutional Review Board for each center.
: All patients provided written informed consent before entering the study.
: All patients provided their consent for their data to be published.
: All data generated or analyzed are included in this article and the supplementary information files. Anonymized datasets and related documents such as the statistical analysis plan, protocol and amendments can be shared upon reasonable request through a data sharing agreement.
: Not applicable.
: Julia Jauch-Lembach and Halimuniyazi Haliduola contributed to the design of the study; Piotr Wiland, Sławomir Jeka, Eva Dokoupilová, Jan Brandt-Jürgens, Juan Manuel Miranda Limón, Miguel Cantalejo Moreira, Raul Veiga Cabello and Norman B. Gaylis contributed to the conduct of the clinical study; Halimuniyazi Haliduola, Julia Jauch-Lembach, Anjali Thakur and Ines Brueckmann contributed to the analysis and interpretation of the results. All authors discussed the results and contributed to the manuscript.