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F.T.\u2019s lab has received research grants (funding to the institution) from AstraZeneca, MSD, Gilead and Agomab. F.T. has received honoraria for consulting or lectures from AbbVie, Falk, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Eisai, Echosens, Gilead, GSK, Intercept, Ipsen, Janssen-Cilag, Madrigal, MSD, Novartis, Novo Nordisk, Orphalan, Pfizer, Roche, Sanofi, and Shionogi. I.M. advises for Univar, Orphalan and Vivet Therapeutics. I.M. received travel grants from Univar, is principal investigator on sponsored studies with Univar and received speaker\u2019s fees from Univar and Orphalan. M.P. has received consultant and\/or speaker fees from W.L. Gore, AstraZeneca, Roche, AbbVie, Gilead, Falk, Boston Scientific, MicroTech, Cook, Orphalan, Ipsen, and Ewimed. M.J. received an honorarium from Ideogen. S.W. advises for Roche, Kerecis, Kexing Biopharma, Revalesio, Eurocept, and Ideogen and has received honoraria from Alexion, Ipsen, Moderna, and Univar. K.H.W. advises for Alexion, Bayer, Chiesi, Eisai, Orphalan, Pfizer, Ultragenyx, Univar, Vivet Therapeutics, Ideogen, Desitin, MonoparTx, and Prime Medicine. None of the authors were employed by Emcure Pharmaceuticals Ltd. or any of its subsidiaries during the conduct of the study. None of the authors served as the principal investigator or as study-site personnel for the original BE\/PK study, and none of the authors were involved in the operational conduct, bioanalytical analysis or statistical analysis of the original study. The authors\u2019 contribution to the present manuscript was limited to scientific interpretation of the available study data, contextualization of the findings, manuscript preparation, and critical revision.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study protocol was reviewed and approved by the SSD Ethics Committee, Sai Snehdeep Hospital, Navi Mumbai, India (DCG(I) registration no. ECR\/1051\/Inst\/MH\/2018). Approval was documented in a decision letter dated 17 July 2018 for Protocol no. BE\/18\/204, Version 01, dated 11 June 2018. Additional study documents, including a note to file and additional consent documentation, were approved on 6 August 2018. The study was conducted with prior ethics approval and in accordance with the study protocol, the Declaration of Helsinki and ICH E6(R2) Good Clinical Practice.","order":2,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Written informed consent was obtained from all participants before any study-specific procedures were performed. The Subject Information Sheet and Informed Consent Form, Version 01 dated 11 June 2018, was reviewed and approved by the SSD Ethics Committee, Sai Snehdeep Hospital, Navi Mumbai, India.","order":3,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable. The manuscript does not contain identifiable individual participant data, images, or videos.","order":4,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Study BE\/18\/204 was not registered in a public clinical trial registry, as confirmed in writing by the sponsor. The study served as the pivotal comparative pharmacokinetic study against the European reference product in the hybrid marketing authorization application under Article 10(3) of Directive 2001\/83\/EC, assessed under decentralized procedure NO\/H\/0322\/001\/DC.","order":5,"name":"Ethics","label":"Trial Registration","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"No custom code was generated for this study. Pharmacokinetic analyses were performed using Phoenix WinNonlin version 8.0, and statistical analyses were performed using SAS version 9.4.","order":6,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Data supporting the findings of this study are available from the corresponding author upon reasonable request and subject to applicable sponsor and regulatory restrictions.","order":7,"name":"Ethics","label":"Data Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"C.J.H. and K.H.W. conceived the manuscript concept and led the scientific interpretation of the pharmacokinetic data. C.J.H. prepared the first draft of the manuscript. K.H.W. provided senior scientific and clinical oversight and substantially contributed to interpretation of the findings in the context of Wilson disease and trientine therapy. S.W. contributed to the regulatory and pharmacoeconomic context, interpretation of the study findings, and manuscript revision. F.T., I.M., M.P., and M.J. contributed clinical, methodological and scientific input, critically reviewed the manuscript for important intellectual content, and supported interpretation of the results. All authors reviewed and approved the final version","order":8,"name":"Ethics","label":"Author Contributions","group":{"name":"EthicsHeading","label":"Declarations"}}]}}