Cockerell, I. http://orcid.org/0000-0002-6810-3941
Guenin, M.
Heimdal, K.
Bjørnvold, M.
Selmer, K. K.
Rouvière, O.
Article History
Received: 22 May 2017
Accepted: 29 January 2018
First Online: 13 February 2018
Ethics approval and consent to participate
: In France, the study was approved by a Medical Ethics Committee (Comité de Protection des Personnes Sud-Est IV, decision L14–95) and declared to the Commission Nationale de l’Informatique et des Libertés (declaration 09–25).In Norway, the study was approved by the Regional Committees for Medical and Health Research Ethics, South-East Region (reference number 2013/176) and by the data protection officer in Oslo University Hospital (reference number 2013/3809).Written informed consent to participate was received from patients over 16 years of age, and from patients’ parents or guardians of patients below 16 year of age and for those lacking the competence to give consent.
: In France, the questionnaire was anonymous and the study design was classified as ‘non-interventional’ by the Ethics Committee. As a result, the need for an informed consent was waived. Written informed consent for publication was received from patients over 16 years of age, and from patients’ parents or guardians of patients below 16 years of age and for those lacking the competence to give consent in Norway.
: The author(s) MG, IC, KKS, declare that they have no competing interests. OR has been investigator in the EXIST-2 trial funded by Novartis. MB have received speaker honoraria from Novartis and is the national coordinator (Norway) of the EXIST-3 trial and an international disease registry collecting data on manifestation and outcomes in patients with tuberous sclerosis complex – TOSCA, funded by Novartis.KH is participating in the advisory board of The Norwegian Association of Tuberous Sclerosis.
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