Wenzler, Eric http://orcid.org/0000-0003-3914-8400
Butler, David
Tan, Xing
Katsube, Takayuki
Wajima, Toshihiro
Funding for this research was provided by:
shionogi
Article History
Accepted: 31 October 2021
First Online: 18 November 2021
Change Date: 6 June 2022
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s40262-022-01146-x
Declarations
:
: This study was supported in part by an investigator-initiated research grant from Shionogi & Co., Ltd, awarded to EW. Other than the named authors, the study sponsor had no role in the study design, data collection/analysis, decision to publish, or preparation of the manuscript.
: Eric Wenzler serves on the speaker’s bureau for Melinta Therapeutics, Astellas Pharma, and Allergan Plc., and on the advisory board for GenMark Diagnostics and Shionogi & Co., Ltd. Takayuki Katsube is currently an employee of Shionogi & Co., Ltd, and Toshihiro Wajima was an employee of Shionogi & Co., Ltd at the time of this work. David Butler and Xing Tan certify no potential conflicts of interest.
: The study design of phase III trials followed US regulatory considerations that were valid in 2016 and were approved by the EMA Committee for Medicinal Products for Human Use (CHMP). Study protocols were approved by relevant national authorities and Institutional Review Boards or independent Ethics Committees. No additional ethical approvals were required for the current study.
: Written informed consent was obtained from all participants during phase III trials. Informed consent was not necessary for the current work.
: Not applicable.
: Protocols for the phase III clinical studies are available on ClinicalTrials.gov as NCT03032380, NCT02714595, and NCT02321800. Data generated from this study are not publicly available due to confidentiality agreements with the sponsor, although they may be provided upon reasonable requests by healthcare providers, investigators, and researchers to address specific scientific or clinical objectives.
: May be made available upon reasonable request.
: EW was responsible for conceptualization, data curation, formal analysis, funding acquisition, investigation, methodology, project administration, resources, supervision, validation, visualization, and writing/reviewing/editing the manuscript. DB contributed to the conceptualization, formal analysis, investigation, and writing/reviewing/editing the manuscript. XT contributed to the formal analysis, investigation, and writing/reviewing/editing the manuscript. TK and TW contributed to the formal analysis, investigation, and reviewing and editing the manuscript. All authors read and approved the final manuscript.