Xu, Binghe http://orcid.org/0000-0003-4195-337X
Li, Wei
Zhang, Qingyuan
Shao, Zhimin
Li, Qiao
Wang, Xiaojia
Li, Huiping
Sun, Tao
Yin, Yongmei
Zheng, Hong
Feng, Jifeng
Zhang, Hong
Lei, Guiyuan
Restuccia, Eleonora
Funding for this research was provided by:
F. Hoffmann-La Roche
Article History
Received: 25 March 2020
Accepted: 2 June 2020
First Online: 20 June 2020
Compliance with ethical standards
:
: All authors received support for third-party writing assistance for this manuscript, provided by F. Hoffmann-La Roche Ltd. BX’s, WL’s, QZ’s, ZS’s, QL’s, XW’s, HL’s, TS’s, YY’s, HZhe’s, and JF’s institutions received an investigator fee from F. Hoffmann-La Roche Ltd for the PUFFIN study. BX also received payment for a consultant/advisory role for Novartis, Roche and AstraZeneca. HZha was an employee of Roche (China) Holding Ltd. GL is an employee of Roche Products Limited. ER is an employee of, and holds stock or other ownership in, F. Hoffmann-La Roche Ltd.
: This study was conducted in full conformance with the International Council for Harmonisation (ICH) E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki, or with the laws and regulations of the country in which the research was conducted, whichever afforded the greater protection to the individual.
: Written informed consent for participation in the study had to be obtained before performing any study-specific screening tests or evaluations. Informed consent forms for enrolled patients and for patients who were not subsequently enrolled were maintained at the study site. The protocol, the informed consent forms, and any accompanying material provided to patients were submitted to the independent ethics committee (IEC) by the Principal Investigator and reviewed and approved before the study was initiated. A full list of the IECs at participating institutions is provided (Online Resource 4).