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Dr. Sirrs reports grants from and advisory board participation for Sanofi Genzyme, grants and travel support from Takeda, and grants and travel support from Amicus, outside of the submitted work. Dr. Bichet reports grants and travel support from and speaker bureau participation for Amicus Therapeutics and Sanofi Genzyme, outside of the submitted work. Dr. Morel reports personal fees from Takeda, outside of the submitted work. Dr. Tocoian and Dr. Lan were employees of Takeda at the time of the study. Dr. West reports grants, personal fees, and travel support from Amicus Therapeutics, Idorsia, Protalix, Sanofi Genzyme, and Takeda, outside of the submitted work.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was conducted according to the International Conference on Harmonization of Good Clinical Practice guidelines and the principles of the Declaration of Helsinki (ClinicalTrials.gov identifier NCT01298141). The study was approved by the relevant institutional review board.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All patients (or their legal guardians\/parents) provided written informed content before enrolling in the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets, including redacted study protocol, redacted statistical analysis plan, and individual participants\u2019 data (after de-identification), behind the results reported in this article, will be available 3 months after the submission of a request through  by researchers who provide a methodologically sound proposal in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"Not applicable.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"AK, SMS, DGB, CFM, AT, LL, and MLW each provided substantial contributions to the interpretation of data for the work, drafted and revised the manuscript critically for important intellectual content, and approved the final version to be published. LL provided the statistical analysis of the data.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}