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A structured abstract is required, and trial registration information (registry name, trial ID, and URL) must be listed at the end of the abstract; for more information, see instructions for preparing Abstracts for Reports of Original Data. A list of 3 Key Points is required (see guidance on preparing Key Points). Maximum length: 3000 words of text (not including abstract, tables, figures, acknowledgments, references, and online-only material) with no more than a total of 5 tables and/or figures. The subtitle should include the phrase "A Randomized Clinical Trial" as relevant. To read more about clinical trials, see the AMA Manual of Style.

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