Muratori, Ida Maria http://orcid.org/0009-0006-0598-6261
Contorno, Francesco http://orcid.org/0009-0006-9578-7804
Amato, Corrado http://orcid.org/0009-0002-9491-5027
Funding for this research was provided by:
Neopharmed Gentili SpA
Article History
Received: 16 June 2023
Accepted: 23 August 2023
First Online: 19 September 2023
Declarations
:
: Ida Maria Muratori, Francesco Contorno, and Corrado Amato declare that they have no competing interests, nor have they received grants related to the study.
: The study was conducted in accordance with the ethical standards of the Declaration of Helsinki of 1964 and its later amendments, the International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline on the Structure and Content of Clinical Trial Reports on Good Clinical Practice (GCP), ISO14155:2020, the European Union Medical Device Regulation MDR 2107/475, and following all other local Italian laws. Registration of the study with the European Union Clinical Trials Register (EudraCT) was not required. Before the study was conducted, the clinical investigation plan and any subsequent amendments were submitted to and approved by the relevant Ethics Committees: Comitato Etico Palermo 1, Azienda Ospedaliero Universitaria Policlinico “Paolo Giaccone”, Palermo, Italy, and the Comitato Etico Catania 1, Azienda Ospedaliero Universitaria Policlinico “G. Rodolico-San Marco”, Catania, Italy. Written informed consent was collected from all patients at enrollment. A progressive unique numerical code was assigned to each patient, and data relating to that patient was kept anonymized throughout the study. Project management, protocol and report medical writing, and monitoring study activities were carried out by the Contract Research Organization (CRO), UNIFARM Research Centre, Catania, Italy. Latis Srl, Genova, Italy, was responsible for the statistical analysis and for preparing the statistical analysis report.