Received: 22 February 2018
Accepted: 29 October 2018
First Online: 20 December 2018
Data availability and materials
: Upon request, and subject to certain criteria, conditions and exceptions (seeExternalRef removedfor more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
: The study was conducted in accordance with ethical principles derived from guidelines that included the Declaration of Helsinki,<sup>40</sup> as well as following all relevant local requirements. The protocol, its amendments and informed consent documentation were reviewed and approved by the institutional review board(s) or independent ethics committee(s) at each site. Patients were required to give informed consent prior to undergoing any study-specific procedure.
: M.D.P. has consulted for Amgen, Pfizer, Genentech/Roche and Samsung Bioepis; H.I. has received research funding from Eisai and Chugai-Roche; R.K.L. is a member of the speakers bureaus for Boehringer Ingelheim, Eisai and AstraZeneca, and has received a partial grant from AstraZeneca for a breast cancer study; R.A., R.E., A.F., R.L., A.V. and D.Y. are employees of and hold stock or stock options in Pfizer; C.Z. was an employee of Pfizer at the time of study conduct and holds stock in the company. The remaining authors declare no conflict of interest.