Updates are available Correction dated 2022-03-14

Article History

Accepted: 28 November 2021

First Online: 22 December 2021

Change Date: 14 March 2022

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s40261-022-01134-w

Declarations

:

: These studies were funded by Boehringer Ingelheim International GmbH (study numbers: 1346-0015 and 1346-0016; Clinicaltrials.gov identifiers: NCT03783000 and NCT03654170).

: UB, MD, YS, SRM, and CS are employees of Boehringer Ingelheim Pharma GmbH; GW, AMT, PL, and TSC are employees of Boehringer Ingelheim Pharmaceuticals Inc.

: The studies were conducted in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonized Tripartite Guideline for Good Clinical Practice (GCP), applicable regulatory requirements, and the standard operating procedures of the sponsor company (Boehringer Ingelheim International GmbH). The study procedures, protocols, and documents were reviewed and approved by the Independent Ethics Committee of the study center as well as the relevant local authorities.

: All participants provided a signed and dated written informed consent form in accordance with GCP and local regulatory and legal requirements, prior to admission to the study.

: Not applicable.

: All publications reporting BI clinical trial data need to include this data disclosure statement to fulfil ICMJE requirements: “To ensure independent interpretation of clinical study results, Boehringer Ingelheim grants all external authors access to relevant material, including participant-level clinical study data, as needed by them to fulfill their role and obligations as authors under the ICMJE criteria. Clinical study documents and participant clinical study data are available to be shared on request after publication of the primary manuscript in a peer-reviewed journal, and if regulatory activities are complete and other criteria met as per the BI Policy on Transparency and Publication of Clinical Study Data (see Medical & Clinical Trials | Clinical Research | MyStudyWindow). Bona fide, qualified scientific and medical researchers are eligible to request access to the clinical study data with corresponding documentation describing the structure and content of the datasets. Upon approval, and governed by a Legal Agreement, data are shared in a secured data-access system for a limited period of 1 year, which may be extended upon request. Prior to providing access, clinical study documents and data will be examined, and, if necessary, redacted and de-identified, to protect the personal data of study participants and personnel, and to respect the boundaries of the informed consent of the study participants. Researchers should use the link to request access to study data and visit Medical & Clinical Trials | Clinical Research | MyStudyWindow for further information”.

: Not applicable.