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Article History

Accepted: 19 April 2022

First Online: 3 June 2022

Declarations

:

: This work was sponsored and funded by Bristol Myers Squibb.

: Y.C., L.L., Y.X., S.Z. and Y.L. are employees and hold equity ownership in Bristol Myers Squibb.

: Not applicable.

: The study was conducted in accordance with the applicable United States (US) Code of Federal Regulations (CFR) governing the Protection of Human Subjects (21 CFR 50, 1980), Financial Disclosure by Clinical Investigators (21 CFR 54, 1998), Institutional Review Board (IRB) (21 CFR 56, 1981), the Investigational New Drug Application (21 CFR 312, 1987), and Applications for Food and Drug Administration Approval to Market a New Drug (21 CFR 314, 1985). As such, these sections of US Title 21 CFR, along with the applicable International Conference on Harmonisation Guidelines (ICH, E6, 1997), are commonly known as Good Clinical Practice (GCP), which are consistent with the Declaration of Helsinki (World Medical Association, 2008). The study was approved by the Schulman Associates Independent Review Board (Cincinnati, Ohio, USA).

: The investigator obtained written informed consent from the subjects prior to any study-related procedures.

: Not applicable.

: The datasets are available from the corresponding author upon request.

: Y.L. and L.L. contributed to conception and design; Y.L. and Y.X. contributed to acquisition of data; Y.C., L.L., S.Z. and Y.L. contributed to analysis; Y.C., S.Z. and Y.L. drafted and revised the article. All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agreed to be accountable for all aspects of the work.