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Authors
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Funding
Funding for this research was provided by:
Pyros Pharamceuticals, Incorporated
Upsher-Smith
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Article History
Received: 10 October 2024
Accepted: 9 December 2024
First Online: 3 February 2025
Declarations
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: The authors, Raenel Gibson, Jay Van Horn, and Ron Klima were employed by Pyros Pharmaceuticals, Incorporated at the time of the study. Insight by Nemera received reimbursement for the conduct of this study. Alcami Corporation received reimbursement for conducting HPLC method validation and HPLC vigabatrin analyses of samples and control samples. Tedor Pharma, Incorporated received reimbursement for the following activities: control sample preparation, sample weight collection, aliquot preparation, and sample blinding. Precision AQ™ received reimbursement for statistical analysis.
: This nonclinical study was approved by a national Institutional Review Board, Castle IRB (Chesterfield, MO). The investigation was conducted in accordance with the 1964 Declaration of Helsinki and its later amendments, and was consistent with Good Clinical Practice and applicable regulatory requirements. Informed consent was obtained from participants prior to performing any study-related procedures.
