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. 2014 Nov 26;9:169. doi: 10.1186/s13023-014-0169-6

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© Schiffmann et al.; licensee BioMed Central Ltd. 2014

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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Timeline and flow of patients in the TKT023 core trial and TKT029 extension study. Seventeen patients who completed TKT023 enrolled in TKT029. Screening values from TKT023 week 25/26 were used as TKT029 baseline values. TKT029 was divided into two phases, before and after a change in the agalsidase alfa manufacturing process. Patients were transitioned to phase 2 treatment ~197 to 223 (mean, 210) weeks after phase 1 baseline agalsidase alfa treatment. Only patients who participated in both phases (the transition safety population) were analyzed for this report. EOW, every other week; agalα, agalsidase alfa; RB, roller bottle; AF, animal free.