Golan, Yoav http://orcid.org/0000-0002-0850-7637
Tang, Yuexin http://orcid.org/0000-0001-6528-4145
Mt-Isa, Shahrul http://orcid.org/0000-0002-7163-8402
Wan, Hong
Teal, Valerie http://orcid.org/0000-0001-7116-5353
Badshah, Cyrus
Dadwal, Sanjeet http://orcid.org/0000-0002-1099-0568
Funding for this research was provided by:
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
Article History
Accepted: 17 March 2021
First Online: 19 April 2021
Declarations
:
: This work was supported by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Medical writing support was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Fees for Open Access were funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
: YT, SM-I, HW, VT, and CB are current or former employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD), and may own stock and/or stock options in Merck & Co., Inc., Kenilworth, NJ, USA. YG is an advisor and speaker for Allergan, MSD, Nabriva, Paratek, and Pfizer, a speaker for Sanofi, and an advisor to Shionogi. SD is an advisor, consultant, and speaker for MSD, an advisory board member for Janssen, and an investigator for Ansun Biopharma, Chimerix, MSD, and Shire/Takeda.
: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD) is committed to providing qualified scientific researchers access to anonymized patient-level data and clinical study reports from the company’s clinical trials for the purpose of conducting legitimate scientific research. The company is also obligated to protect the rights and privacy of trial participants and, as such, has a procedure in place for evaluating and fulfilling requests for sharing company clinical trial data with qualified external scientific researchers. The process includes submission of data requests to the MSD data-sharing website available at ExternalRef removed. Data will be made available for request after product approval in the US and EU or after product development is discontinued. There are circumstances that may prevent MSD from sharing the requested data.
: This post-hoc analysis is based on data from the phase III clinical trial (NCT02137772), which was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines. The institutional review board at each center approved the trial.
: This post-hoc analysis is based on data from the phase III clinical trial (NCT02137772). All patients from the trial provided written informed consent.
: YG participated as a principal investigator, in the study data analysis, and in the writing of the manuscript. SM-I participated in the study analysis plan, performed and reviewed analyses, interpreted data, and critically reviewed the manuscript. YT, HW, and VT participated in the study analysis plan, interpreted data, and critically reviewed the manuscript. CB participated as the clinical director of the study, in the design and conduct of the study, interpreted data, and critically reviewed the manuscript. SD participated as senior/co-investigator, in the study design and data analysis, and critically reviewed the manuscript.