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. 2017 Oct 7;37(5):459–465. doi: 10.1097/INF.0000000000001808

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Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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FIGURE 1. — Design of study A4001031. S1, Stage 1: Intensive PK/dose finding (4–12 weeks): Minimum of 12 (Cohort 1) and 10 children (in each of Cohorts 2–4) to complete Stage 1 before entering Stage 2. S2, Stage 2: Safety/Efficacy: Following the minimum numbers being reached for Stage 1, all new patients then directly entered Stage 2.