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Article History

Accepted: 28 September 2021

First Online: 18 October 2021

Declarations

:

: This study was supported by Boehringer Ingelheim International GmbH (BI).

: MCV reports grants from BI, Ferrer and Janssen-Cilag; fees for serving as an advisor or review panel member for BI and Janssen-Cilag; and speaker fees from BI, Janssen-Cilag, Novartis, Roche. AG-D-C reports consultancy fees from BI and Janssen. MK reports grants from BI and Roche and consultancy fees from BI, Galapagos, Roche. MA, KM, SRM, SW and MG are employees of BI.

: Researchers may request access to de-identified participant clinical study data with documentation describing the structure and content of the datasets. Upon approval, and governed by a Data Sharing Agreement, data would be shared in a secured data-access system for a period of 1 year, which may be extended upon request. Researchers should use the link to request access to study data.

: MA, KM, SRM, SW and MG were involved in the design of the study. MCV, AG-D-C and MK were involved in data acquisition. SRM and KM were involved in data analysis. All authors were involved in the interpretation of the data and in the writing and critical review of the manuscript and have approved the final version.

: The clinical protocol was approved by an independent ethics committee or institutional review board at each participating centre.

: All patients provided written informed consent before study entry.

: Not applicable.