Wang, Xiaofeng
Vilchez, Regis A.
Funding for this research was provided by:
Mallinckrodt Pharmaceuticals
Article History
Accepted: 5 September 2021
First Online: 17 November 2021
Declarations
:
: This study was sponsored by Mallinckrodt Pharmaceuticals, which participated in the review of and decision to publish this manuscript.
: Xiaofeng Wang is a former employee of Mallinckrodt Pharmaceuticals. Regis A. Vilchez is a current employee of Mallinckrodt Pharmaceuticals. The study sponsor was involved in the study design and data collection, analysis, and interpretation.
: An institutional review board approved each study protocol.
: All participants gave written informed consent prior to the initiation of study procedures.
: Not applicable (no personal data were reported).
: Discussion of statistical endpoints and analysis are included in the manuscript. Summary aggregate (basic) results (including adverse event information) and the protocol for study HE209 will be available on clinicaltrials.gov (NCT01966419) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
: NONMEM (version 7.4, Icon Development Solutions, Ellicott City, MD, USA) and R (version 3.5.2.).
: XW drafted the manuscript; conducted pharmacokinetics and exposure–adverse event analyses, and interpreted the outcome of the analyses included in the manuscript; was a key contributor to the design of the two clinical studies; and approved the manuscript. RAV designed and analyzed the study, and reviewed and approved the manuscript.
: None.