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es (Additional files 1 and 2), accessible from the ClinicalTrials.gov website. In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocols. The study protocols have been reported in accordance with the Standard Protocol Items Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional files 3 and 4). The full protocols are attached as additional files (Additional files 1 and 2), accessible from the
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