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Authors
Pisak, Mehmet Nevzat https://orcid.org/0000-0001-5444-6452
Bereket, Edibe https://orcid.org/0009-0006-6386-0376
Erenmemisoglu, Aydin https://orcid.org/0000-0002-9277-1333
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Article History
Received: 22 October 2024
Accepted: 21 July 2025
First Online: 6 August 2025
Declarations
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: The study protocol was approved by the Institutional Review Board/Independent Ethics Committee/(lRB/IEC) at APIC/PRU clinical site. All participants provided written informed consent prior to any study procedures. The trial was conducted in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. While the study adhered to ethical principles, it was not prospectively registered in a publicly accessible database before recruitment of the first subject. The EMA bioequivalence guidance and CONSORT recommendations were followed in the design and reporting of the trial.
: Not applicable (no individual patient data are reported that would require personal consent for publication).
: Mehmet Nevzat Pisak is the Chairman of Imuneks Farma Pharmaceuticals Industry and Trade Inc. Edibe Bereket, Pharm is Regulatory Affairs Director and Clinical Research Director at Imuneks Farma. Aydin Erenmemisoglu declares that he has no conflict of interest, and he has no financial or employment ties with the company or the other two authors.
