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Development and validation of the TSC-PROM1616FundingThe project was funded by the Dutch TSC Foundation but was not involved in the study.Competing interestsAvE is part of the scientific advisory board, funded by Jazz Pharmaceuticals, and is an investigator in studies of Jazz Pharmaceuticals. PJdV, MdW, and AJ have provided consultancy to Jazz Pharmaceuticals. LtH works at a department with license for distributing the CBCL in Dutch language areas. The other authors declare that they have no competing interests.Authors’ contributionsAM had a major role in the recruitment and acquisition of data, analysis and interpretation of data, and drafting of the manuscript. ML performed the statistical analyses, provided methodological support, and was a major contributor in drafting the manuscript. LH was involved in the validation of the outcome measure, provided methodological support, and contributed to drafting the manuscript. WdRG had a major role in recruitment, acquisition of data, and drafting the manuscript. PJ was part of the expert group, made substantial contributions to the conception and design of the study, and contributed to drafting the manuscript. AR was part of the expert group, made substantial contributions to the conception and design of the study, and contributed to drafting the manuscript. LtH was part of the expert group, made substantial contributions to the conception and design of the study, and contributed to drafting the manuscript. LdG was part of the expert group, had a major role in recruitment, and contributed to drafting the manuscript. MdW was part of the expert group, made substantial contributions to the conception and design of the study, and contributed to drafting the manuscript. AJ made substantial contributions to the conception and design of the study and contributed to drafting the manuscript. TG had a major role in recruitment and acquisition of data and contributed to drafting the manuscript. JC had a major role in recruitment and acquisition of data and contributed to drafting the manuscript. PdV was part of the expert group, made substantial contributions to the conception and design of the study, and contributed to drafting the manuscript. AvE initiated and designed the study, was part of the expert group, had a major role in the acquisition of data, interpreted the data, and drafted the manuscript. All authors read and approved the final manuscript.Annelieke Muller sHL.indd 161 14-11-2023 09:07