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. 2021 Feb 17;71(2):254–264. doi: 10.1136/gutjnl-2020-323608

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© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Clinically meaningful reductions in weight, liver fat and homeostatic model assessment of insulin resistance (HOMA-IR) with duodenal mucosal resurfacing (DMR). Median weight (kg) change from baseline to 24 weeks (DMR vs sham procedure) in the European (A) and Brazilian (B) modified intention-to-treat (mITT) and per-protocol (PP) populations. Median relative liver MRI proton density fat fraction (MRI-PDFF) per cent change from baseline to 12 weeks in patients with baseline MRI-PDFF >5% (*) in the European (C) and Brazilian (D) mITT and PP populations. Median fasting plasma glucose (FPG; millimoles per litre) change from baseline to 24 weeks (DMR vs sham procedure) in the European (E) and Brazilian (F) mITT and PP populations. Median HOMA-IR change from baseline to 12 weeks (DMR vs sham procedure) in the European (G) and Brazilian (H) mITT and PP populations. Data for continuous variables are on non-imputed unadjusted descriptive statistics based on patients with non-missing values. Treatment comparison one-sided p value based on analysis of covariance model on ranks (modified ridit scores) where post rescue values are first set to missing. Last rank carried forward on ranks was used for missing data for FPG levels, weight and HOMA-IR endpoints. HOMA-IR was determined as (FPG * fasting insulin)/135, where FPG levels were measured in millimoles per litre and fasting insulin is measured in picomoles per litre.