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Article History

Received: 15 September 2025

Accepted: 19 February 2026

First Online: 22 May 2026

Change Date: 25 June 2026

Change Type: Update

Change Details: Affiliation of author Nazma Morde updated.

Declarations

:

: The authors declare no conflict of interest.

: The study was conducted in accordance with the Declaration of Helsinki. 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).

: All participants provided written informed consent prior to trial-related procedures.

: 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.

: Final model code is provided as Supplementary1_WtClmodel.for.

: 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.

: All study participants provided informed consent for the publication of anonymized data and findings. No identifying information is included in the manuscript.