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Article History

Received: 8 February 2019

Accepted: 8 March 2019

First Online: 20 April 2019

Compliance with ethical standards

:

: A.C. Verschuur is a medical consultant to Pfizer Inc. V. Bajčiová declares no conflicts of interest. L. Mascarenhas declares no financial conflicts. R. Khosravan, X. Lin, and A. Ingrosso are employees of and own stock in Pfizer Inc. K.A. Janeway has received travel funding from Pfizer and LOXO Oncology.

: All procedures were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments.

: Before inclusion in the study, all patients or their parent/legal guardian provided signed, informed consent.

: 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.