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Article History

Received: 21 August 2021

Accepted: 10 October 2021

First Online: 24 October 2021

Declarations

:

: All procedures contributing to this work complied with the ethical standards of the relevant national and international committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. The protocol was peer-reviewed in the Department of Psychiatry at the University of Cape Town and submitted for ethical approval by the Faculty of Health Sciences, Human Research Ethics Committee (Ethics Ref 340/2015). Additional study sites obtained ethical approval or waivers from their respective HREC/IRB bodies.

: Not applicable.

: This work was supported by a Ph.D. studentship from the Tuberous Sclerosis Association in the United Kingdom (Grant: 2014-S01) (LL), a project grant from the King Baudoin Foundation Fund Dr & Mrs Charles Tournay-Dubisson to PdV and AJ (2019-J1120010-213544), and by the National Research Foundation and Struengmann Fund, University of Cape Town (to PdV). The funding bodies played no role in the design of the study in collection, analysis, and interpretation of data, or in writing the manuscript. PdV was a study steering committee member of three phase III trials sponsored by Novartis. PdV and AJ are on the scientific advisory group of the TOSCA international disease registry sponsored by Novartis. MS reports grant support from Novartis, Roche, Biogen, Astellas, Aeovian, Bridgebio, Aucta and Quadrant Biosciences unrelated to this project. He has served on Scientific Advisory Boards for Roche, Celgene, Regenxbio, Alkermes and Takeda.