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. 2019 Feb 1;3(3):365–381. doi: 10.1002/hep4.1305

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© 2019 The Authors. Hepatology Communications published by Wiley Periodicals, Inc., on behalf of the American Association for the Study of Liver Diseases.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

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Study design. Dose selection for cohort B was guided by the tolerability of maralixibat in the first 18 patients who completed 4 weeks of treatment in cohort A; the decision was based on the number of patients who lowered their dose or suspended or stopped active treatment owing to gastrointestinal intolerance related to the maralixibat (≥5 patients, cohort B would have received 5 mg maralixibat; <5 patients, cohort B would have received 20 mg maralixibat). Clinic visits were scheduled at baseline (week 0) and weeks 2, 4, 8, and 13. Telephone contact was scheduled at weeks 1, 3, and 17 (follow‐up call).