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Article History

Received: 12 November 2018

Accepted: 7 May 2019

First Online: 28 May 2019

Ethics approval and consent to participate

: The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonization Guidelines for Good Clinical Practice and local regulations. An institutional review board or independent ethics committee at each site approved the protocol, consent form, and any other written information provided to patients or their legal representatives. All patients or their legal representatives gave written informed consent prior to study entry.

: Not applicable.

: Janusz Jaworski reports trial payment for this research study and lecture fees from Sandoz. Marco Matucci-Cerinic reports no conflicts of interest. Hendrik Schulze-Koops reports personal fees from Sandoz/Hexal, during the conduct of the study, and grants and personal fees from Novartis, outside the submitted work. Maya Buch reports personal fees from Sandoz, during the conduct of the study. Eugeniusz J. Kucharz reports no conflict of interest. Yannick Allanore reports personal fees from Sandoz, grants and personal fees from Pfizer, and grants and personal fees from Roche, during the conduct of the study. Arthur Kavanaugh reports personal fees from Sandoz, outside the submitted work. Philip Young and Goran Babic are employees of Hexal AG.

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