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Reyna, and Nayla Mumneh are employees of Novartis and own stock\/other equities. Shannon Ritter, Anish Patel, and Omar Dabbous were employees of Novartis at the time of this study and own stock\/other equities. Anish Patel is currently an employee of Nanoscope Therapeutics Inc. Omar Dabbous is currently an employee of Komar Pharmaceuticals and Curestack.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The START [], STR1VE-US [], and STR1VE-EU [] study protocols were approved by the institutional review boards at each participating institution (Table ), and study procedures were conducted according to the principles outlined in the Declaration of Helsinki.\u00a0The RESTORE registry is being conducted in accordance with established research principles, local treatment practices and regulations, and guidelines of the International Council on Harmonisation. All parents or guardians provided written informed consent before any study procedures were performed.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}