Marth, Katharina http://orcid.org/0000-0002-6012-5206
Renner, Andreas
Langmayr, Georg
Pohl, Wolfgang
Nguyen, Duc Tung
Kuhl, Hans Christian
Funding for this research was provided by:
Viatris
Article History
Accepted: 7 December 2023
First Online: 13 February 2024
Declarations
:
: This study and medical writing support in the development of this article was funded by Mylan Inc. (Canonsburg, PA, USA), now Viatris.
: Katharina Marth has conducted received speaker/consultancy fees and financial support for conference attendance from GSK, Novartis, Chiesi, ThermoFisher, Medmedia, Teva, and Meda. Andreas Renner has received speaker/consultancy fees from Meda Pharma GmbH & Co. KG. Georg Langmayr (now Viatris) has no conflicts of interest that are directly relevant to the content of this article. Duc Tung Nguyen is an employee of Meda Pharma GmbH & Co. KG (a Mylan Company, now Viatris). Wolfgang Pohl.
: The study was performed in accordance with the standards of ethics outlined in the Declaration of Helsinki. This investigation represented a NIS as defined by European regulations (EU 2001; ICH E2E 2004; EMA 2012), i.e., the rules imposed for this observational plan did not interfere with the physician’s common therapy. The study was approved on 30 July, 2015 by the Ethics Committee “Ethikkommision der Stadt Wien”. The study was carried out in accordance with the national laws and guidelines current at that time: the current Austrian drug law and the Austrian regulations for conducting noninterventional studies (Available from: . [Accessed 5 Dec 2023].
: Written informed consent by the patient and (if applicable) in addition by the caregiver for patients below 18 years of age were taken before enrollment in the study.
: Not applicable.
: The datasets generated during the current study are not publicly available because the data reside in a proprietary database maintained by Meda Pharma GmbH & Co. KG (a Mylan Company, now Viatris); however, data are available from the corresponding author on reasonable request and with permission of Mylan Inc. (now Viatris).
: Not applicable.
: HCK and DTN contributed to the design and implementation of the research, analysis of the results, interpretation of the data, and writing of the manuscript. KM, AR, GL, and WP performed the experiments. All authors extensively reviewed and contributed to the manuscript and approved the final version for publication.