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AA and JZ are full-time employees of and declare stock holdings and\/or stock options from Pfizer; and had travel expenses paid or reimbursed by Pfizer. JK is a full-time employee of and declares stock holdings and\/or stock options from Pfizer; and declares stock holdings and\/or stock options from Abbot and AbbVie. PN-P is a full-time employee of and declares stock holdings and\/or stock options from Pfizer; and declares stock holdings and\/or stock options from Bristol-Myers Squibb and Celgene. JC was a full-time employee of and declares shareholdings, stock holdings, and\/or stock options from Pfizer. LN has received honoraria from Bayer, Celgene, Gamida Cell, Gilead Sciences, Janssen Oncology, Juno Therapeutics, Novartis, Pfizer, Spectrum Pharmaceuticals, and TG Therapeutics; and research funding from Celgene, Genentech\/Roche, Janssen Biotech, Karus Therapeutics, LAM Therapeutics, and TG Therapeutics.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"This study was conducted in compliance with the ethical principles originating in, or derived from, the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines and was reviewed and approved by institutional review boards and\/or independent ethics committees. All local regulatory requirements were followed, particularly those affording greater protection to the safety of trial participants. The study was sponsored by Pfizer and is registered on ClinicalTrials.gov (NCT02213263) and EudraCT (2014-000132-41).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients provided informed consent before undergoing any screening procedures.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"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 USA 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.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"AA, JC, NK, JK, and PN-P contributed to the conception or design of the study; LN contributed to the acquisition of data; and JZ contributed to the data analysis. All authors participated in the interpretation of the data, contributed to the drafting or revision of the manuscript, read and gave final approval of the submitted manuscript, were involved in the decision to submit the manuscript for publication, and accept accountability for all aspects of the work.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}