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Article History

Received: 23 August 2020

Revised: 26 March 2021

Accepted: 31 March 2021

First Online: 13 April 2021

Declarations

:

: Charles Chuah has received research funding from Bristol-Myers Squibb and honoraria from Bristol-Myers Squibb, Novartis, Korea Otsuka Pharmaceuticals and Chiltern International. Kiat Hoe Ong served on advisory boards for Abbvie, AstraZeneca, Johnson & Johnson, and Novartis; received speaker fees from Johnson & Johnson and Novartis; and received conference registration/travel accommodations from Amgen, Bristol-Myers Squib, and Celgene. Young Rok Do served as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Takeda, and Ilynag Pharma. Masayuki Ohkura and Chiho Ono are employees of Pfizer. Andrea Viqueira is an employee of and owns stock in Pfizer. Jorge E. Cortes has received research funding from Bristol-Myers Squibb, Novartis, Pfizer, Takeda, and Sun Pharma and served as a consultant for Bristol-Myers Squibb, Novartis, Pfizer, Takeda, and Fusion Pharma. Tim H. Brümmendorf has received research funding from Novartis and Pfizer and participated in advisory boards and/or satellite symposia for Ariad, Bristol-Myers Squibb, Janssen, Merck, Novartis, and Pfizer. Liang Piu Koh, Tontanai Numbenjapon, and Dae Young Zang declare that they have no conflicts of interest.

: Upon request, and subject to certain criteria, conditions and exceptions (see for 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.