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. 2023 Feb 24;14:1127585. doi: 10.3389/fneur.2023.1127585

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Copyright © 2023 Hernández-Jiménez, Abad-Santos, Cotgreave, Gallego, Jilma, Flores, Jovin, Vivancos, Molina, Montaner, Casariego, Dalsgaard, Hernández-Pérez, Liebeskind, Cobo and Ribo.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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Scheme of APRIL trial. APRIL is divided into two Phases. Phase Ib is a single ascending dose where 8 patients (6 ApTOLL: 2 Placebo) will be enrolled in 4 sequential ascending dose arms (0.025, 0.05, 0.1, and 0.2 mg/kg). After analyzing safety results from Phase Ib, the DSMB will select two doses to be administered in Phase IIa. In Phase IIa three parallel arms (Dose A, Dose B, and Placebo) will be studied. At the moment of this publication, Phase Ib is completed and the doses 0.05 and 0.2mg/kg have been selected to continue during Phase IIa.