Hunter, David J.
Chang, Chi-Ching
Wei, James Cheng-Chung
Lin, Hsiao-Yi
Brown, Carl
Tai, Tien-Tzu
Wu, Chih-Feng
Chuang, Wing Chia-Ming
Shih, Sheue-Fang
Funding for this research was provided by:
Taiwan Liposome Company
Article History
Received: 2 September 2021
Accepted: 6 February 2022
First Online: 21 February 2022
Declarations
:
: The study protocol, all study protocol amendments, written study participant information, informed consent form, Investigator’s Brochure, and any other relevant documents were reviewed and approved by an independent ethics committee (IEC) or institutional review board (IRB) at each study center. The study was conducted in accordance with the approved protocol and the ethical principles derived from international guidelines, including the Declaration of Helsinki (2013), International Council for Harmonisation, Good Clinical Practice Guidelines, and applicable laws and regulations. The ethical committees associated with this study include the following: Cheng Hsin General Hospital IRB ((570)105B-39), Taipei Medical University-Joint IRB (N201609008), Kaohsiung Medical University Chung-Ho Memorial Hospital IRB (KMUHIRBF(II)-20160109), Shin Kong Wu Ho-Su Memorial Hospital IRB (20170202C), China Medical University and Hospital Research Ethics Committee (HREC) (CMUH106-REC3-056), Show Chwan Memorial Hospital IRB (1060212), Chung Shan Medical University Hospital IRB (CS2-17055), Taichung Veterans General Hospital IRB (SC17266-B), Northern Sydney Local Health District HREC (RESP/16/296), Bellberry Human Research Ethics Committee (2016-10-748), and Northern Sydney Local Health District HREC (RESP/16/296).
: Not applicable.
: David J Hunter provides consulting advice to Merck Serono, Pfizer, Lilly, and TLCBio. James Cheng-Chung Wei received research grant, speaker fee, or advisor board from Pfizer, Abbott, Abbvie, Bristol-Myers Squibb, Eli Lilly, JNJ, UCB, MSD, GSK, Chugai, Roche, Celgene, Sanofi-Aventis, and Novartis. Sheue-Fang Shih, Carl Brown, Tien-Tzu Tai, and Wing Chia-Ming Chuang are employees and shareholders of the Taiwan Liposome Company. Chih-Feng Wu was an employee of Taiwan Liposome Company during the trial conduct but was no longer in the company at the time of this manuscript submission.The rest of the authors declare that they have no competing interests.