Wang, Xiaofeng
Tseng, Jack
Mak, Carmen
Poola, Nagaraju
Vilchez, Regis A.
Funding for this research was provided by:
Mallinckrodt Pharmaceuticals
Article History
Accepted: 1 June 2021
First Online: 14 June 2021
Declarations
:
: This study was sponsored by Mallinckrodt Pharmaceuticals, which participated in the review of and decision to publish this manuscript.
: Xiaofeng Wang, Carmen Mak, and Nagaraju Poola are former employees of Mallinckrodt Pharmaceuticals. Jack Tseng and Regis A. Vilchez are current employees 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 provided written informed consent prior to initiation of study-related procedures.
: Not applicable (no personal data were reported).
: Discussion of statistical endpoints and analysis are included in the article. 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.
: Phoenix<sup>®</sup> WinNonlin<sup>®</sup> Version 6.4 (Certara Inc., Princeton, NJ, USA), NONMEM Version 7.4 (ICON, Ellicott City, MD, USA), and R Version 3.5.
: XW conducted the pharmacokinetic and exposure–adverse event analyses, interpreted the outcome of the analyses included in the manuscript, and was a key contributor to the design of the two clinical studies. JT participated in the acquisition/collection of the data and interpretation of the data. CM reviewed and interpreted the data. NP participated in the data summary, review, and interpretation. RAV designed and analyzed the study. All authors drafted the manuscript or revised it critically for important intellectual content and approved the version to be submitted.