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Malhotra, Xiaoxing Wang, Luke Fostvedt, Hernan Valdez, and Timothy Nicholas are employees and shareholders of Pfizer Inc.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"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 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":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"JW analyzed the data. All authors made substantial contributions to the interpretation of data and participated in drafting and critically revising the work. All authors approved the final version to be published and agree to be accountable for all aspects of the work.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}},{"value":"The study protocols were approved by the Institutional Review Boards\/Ethics Committees of the study sites, and all participants gave written informed consent before participation in the studies. The studies were conducted according to the International Conference on Harmonization Guidelines for Good Clinical Practice.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants provided written informed consent before participation in the studies.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"These analyses included data from the following studies: NCT01835197, NCT02163161, NCT02201524, NCT02780167, NCT03349060, NCT03575871, NCT03634345, NCT03637790, NCT03626415, NCT03386279, and NCT03937258.","order":10,"name":"Ethics","group":{"name":"EthicsHeading","label":"Trial registration"}}]}}