Document is current

Article History

Received: 23 May 2022

Accepted: 7 August 2022

First Online: 24 August 2022

Declarations

:

: KO is an employee of and holds equity ownership in Bristol Myers Squibb. YC is an employee of and holds equity ownership in Bristol Myers Squibb. RWH is an employee of Pharmaceutical Product Development (PPD), a contract research organization for this study supported by Bristol Myers Squibb. MarkT is an employee of and holds equity ownership in Bristol Myers Squibb. MichaelT is an employee of and holds equity ownership in Bristol Myers Squibb and has planned, issued, or pending patents with Bristol Myers Squibb. BH is an employee of and holds equity ownership in Bristol Myers Squibb. LL is an employee of and holds equity ownership in Bristol Myers Squibb. YX is an employee of and holds equity ownership in Bristol Myers Squibb. SS is an employee of and holds equity ownership in Bristol Myers Squibb. LNC is an employee of and holds equity ownership in Bristol Myers Squibb. SZ is an employee of and holds equity ownership in Bristol Myers Squibb. MP is an employee of and holds equity ownership in Bristol Myers Squibb. GK is an employee of and holds equity ownership in Bristol Myers Squibb.

: The study was conducted in compliance with the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice and applicable regulatory requirements. The protocol complied with Declaration of Helsinki, as well as any applicable guidelines of the USA, the country where the study was conducted. The protocol was submitted to an independent review board (Salus IRB, Austin, TX, USA) for review and written approval.

: Written informed consent was obtained from participants at screening, prior to the conduct of any study-related procedures.