Main Outcome Measures
Publication stageIn Press Accepted Manuscript
Funding statement: No funding was received for this study.
Disclosure statement: The authors do not have any conflicts of interest to report.
Attestation Statement: The subjects in this trial have not concomitantly been involved in other randomized trials. Data regarding any of the subjects in the study has not been previously published. Data will be made available to the editors of the journal for review or query upon request.
Trial registration: NCT04048772; https://clinicaltrials.gov/ct2/show/NCT04048772. Registration date: August 7, 2019. First subject enrolled on August 9, 2019.
Trial registration NCT04048772
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