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. 2023 Jun 12;16:17562848231174277. doi: 10.1177/17562848231174277

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© The Author(s), 2023

This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).

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Figure 3. — TEAEs by treatment groups and courses through 6 months. (a) Percentage of participants with TEAEs by maximum severity. Participants with multiple events were counted according to the event with the maximum severity. The severity grade of events with a missing severity grade were categorized as the maximum severity. (b) Percentage of participants with gastrointestinal disorder system organ class TEAEs by maximum severity.

^aSafety follow-up was reset to allow for 6 months of follow-up after receiving OL treatment.

^bIncludes any TEAE experienced by a participant in the three groups (RBL Only, Placebo + OL RBL, and RBL + OL RBL) that were exposed to RBL, which includes events after blinded placebo in the Placebo + OL RBL group.

Percentage is calculated using the number of participants in the column heading as the denominator.

CDI, Clostridioides difficile infection; OL, open-label; RBL, fecal microbiota, live-jslm; TEAE, treatment-emergent adverse event.