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The Independent Institutional Review Board approved all four PK studies included in the datasets used for the PopPK model. The EC approval code (EC approval dates in dd\/mm\/yyyy format) of the four PK studies are as follows: 08-11-261 (14\/12\/2008), 10-04-027 (12\/09\/2010), 10-11-066 (18\/01\/2011), and 11-08-041 (10\/11\/2011).","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All participants provided written informed consent prior to trial-related procedures.","order":3,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Restrictions apply to the availability of these data. Data were obtained from Cipla Ltd. and will require permission from Cipla Ltd. before the raw data are shared.","order":4,"name":"Ethics","label":"Availability of Data and Material","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Final model code is provided as Supplementary1_WtClmodel.for.","order":5,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Conceptualization: J.R. and S.S. Methodology, formal analysis: J.R. and M.D., writing-original draft preparation: J.R., review and editing-S.S. and M.D., supervision: M.D. and S.S., study conduct: N.M., bioanalysis: R.N. and J.P. All authors have read and agreed to the published version of the manuscript.","order":6,"name":"Ethics","label":"Author Contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All study participants provided informed consent for the publication of anonymized data and findings. No identifying information is included in the manuscript.","order":7,"name":"Ethics","label":"Consent to Publish","group":{"name":"EthicsHeading","label":"Declarations"}}]}}