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The therapeutic drug monitoring program performed in the international AIEOP-BFM ALL 2009 trial has been in part supported by an unrestricted grant from the company Servier (and previously from medac GmBH, Sigma-Tau, Baxalta, and Shire who have marketed the drug during the present study period). No sources of funding were used to assist with the preparation of this manuscript.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"M. Schrappe and the ALL-BFM Study Center received funding from medac, Shire, Sigma-Tau, Servier, and Jazz Pharmaceuticals for research, and for functions on advisory boards. C. Rizzari received institutional grants for PEG-asparaginase pharmacological studies aimed at the therapeutic drug monitoring of asparaginase within the AIEOP-BFM ALL 2009 study, fees for participation to advisory boards, and invited lectures for medac, Sigma-Tau, Baxalta, Shire, and Servier who were and currently are the owners of the product that is the object of this pharmacological study. C. Lanvers-Kaminsky held invited talks for Sigma-Tau, Erytech, and Jazz Pharmaceuticals, received honoraria for consultancy from Erytech, and received a travel grant from Servier. A. M\u00f6ricke received honoraria from Baxter. J. Boos served personally as a consultant and participated in advisory as well as in safety boards for medac GmbH. He received support for travel from Eusa Pharma, Jazz Pharmaceuticals, Baxalta, Shire, and Servier. For medac GmbH, Eusa Pharma, Jazz Pharmaceuticals, Baxalta, Servier, Shire, and Sigma-Tau, he held invited lectures. In addition, institutional grants in the context of ASNase drug monitoring from more or less all ASNase providers contributed to the therapeutic drug monitoring program, including medac GmbH, Eusa Pharma, Jazz Pharmaceuticals, Baxalta, Servier, Shire, and Sigma-Tau (all representing the varying marketing authorization holders of <i>E. coli<\/i> ASNase, PEG-ASNase, and Erwinase). No other authors declare a conflict of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"JB, GW and CL-K designed the research; AM, MZi, JS, PS and MS collected the data; GW and JG performed the statistical analyses; GW, CL-K, CS, GH, SGW, and JB performed and discussed the pharmacokinetic analysis; JB, GW, CL-K, JG, AM, MZi, JS, PS, MS, CR, and MZu discussed and interpreted the results during scientific meetings of the Asparaginase Working Party. GW, CL-K, CS, and JB wrote the manuscript; all authors reviewed the manuscript.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors' contributions"}},{"value":"The study (EudraCT Number 2007-004270-43) was approved by each national and local review board and was conducted in accordance with the Declaration of Helsinki and national laws.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Informed consent was obtained from the parents or guardians of each patient included in the study as required by ethical standards and national guidelines.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets generated and\/or analyzed during the current study are not publicly available due to data protection rules and the fact that the complexity of the data does not allow for full anonymization.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"The NONMEM code of the final pharmacokinetic model together with an example NONMEM dataset are provided in the supplement.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}}]}}