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. 2019 May 14;9(5):e026779. doi: 10.1136/bmjopen-2018-026779

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© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Sample size calculation: Assuming the sensitivity for detecting grade 3 (or higher) toxicity is 99%. Expected prevalence of grade 3 toxicity in the study population is 2.5%.