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Maciej Bryl has received consulting fees or honoraria from Boehringer Ingelheim, Novartis, AstraZeneca, MSD, and Bristol-Myers Squibb, support for travel from Hoffmann-La Roche\/Genentech, Boehringer Ingelheim, MSD, Bristol-Myers Squibb, Pfizer, and AstraZeneca, and payments for lectures from Roche\/Genentech, Boehringer Ingelheim, MSD, Bristol-Myers Squibb, Pfizer, and AstraZeneca. Kostas Syrigos has received honoraria and consulting fees from AstraZeneca, MSD, Roche, and Bristol-Myers Squibb. Angel H. Bair, Fiona Hilton, and Katherine Liau are employees of and hold stock or stock options in Pfizer. Kazuo Kasahara has received honoraria from Pfizer, Chugai Pharmaceutical, MSD, AstraZeneca, Bristol-Myers Squibb, and IQVIA. Igor Bondarenko, Vladimir Vladimirov, and Manuela Zereu disclose no conflicts of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict 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 Council for Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed. The final protocol, any amendments, and informed consent documentation were reviewed and approved by the institutional review boards and\/or independent ethics committees at each of the investigational centers participating in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"A signed and dated informed consent document was required from each patient before any screening procedures were done.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"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 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\u00a0months 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":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability"}}]}}