Tsukada, Hironobu
Chen, Yu-Luan
Xiao, Guangqing
Lennek, Lisa
Milanovic, Snezana M.
Worden, MaryAlice
Polhamus, Daniel G.
Chiu, Yu-Yuan
Hopkins, Seth C.
Galluppi, Gerald R.
Funding for this research was provided by:
Sunovion
Article History
Accepted: 2 October 2023
First Online: 26 October 2023
Declarations
:
: This study was fully funded by Sunovion Pharmaceuticals Inc.
: Hironobu Tsukada is an employee of Sumitomo Pharma Co., Ltd. Yu-Luan Chen, Guangqing Xiao, Lisa Lennek, Snezana M. Milanovic, MaryAlice Worden, Yu-Yuan Chiu, Seth C. Hopkins, and Gerald R. Galluppi are employees of Sumitomo Pharma America. Daniel G. Polhamus is an employee of Metrum Research Group and was working under a contract from Sunovion Pharmaceuticals, Inc.
: Available from the corresponding author on reasonable request.
: The study protocol, including the final version of the subject informed consent form, was approved by the following IRB before enrollment of any subjects into the study: Midlands IRB, 8417 Santa Fe Drive, Suite 100, Overland Park, KS 66212, USA. This study was conducted in accordance with the protocol, International Council for Harmonisation (ICH) Good Clinical Practice, ICH guidelines, and the ethical principles that had their origin in the Declaration of Helsinki. The study was conducted in accordance with applicable local law(s) and regulation(s).
: All subjects signed the informed consent form before any study procedures were performed.
: HT, Y-LC, GX, LL, SMM, MAW, Y-YC, SCH, and GRG contributed to the study design, and participated in the conduct of the study and data collection. All authors analyzed the data, wrote the manuscript, and approved the final manuscript.