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. 2021 Aug 19;9(5):e00842. doi: 10.1002/prp2.842

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© 2021 The Authors. Pharmacology Research & Perspectives published by British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics and John Wiley & Sons Ltd.

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Study design and dose escalation scheme. Eight participants were randomized to each cohort; six to active treatment and two to placebo. Eight participants in Part A, Cohort 4, crossed over to Part C. ^aThe primary observation period was reduced to 17 days for Cohorts 3–5 of Part B, since available clinical data showed this timeframe provided sufficient safety and tolerability monitoring; ^bSingle‐dose cohort escalation (Part A): safety data from a single dose plus 1 week in‐house; ^cMultiple‐dose cohort escalation (Part B): safety data from 2 weeks of treatment until the end of the in‐house period. BID, twice daily; QD, once daily