Zanier, Elisa R.
Pischiutta, Francesca
Rulli, Eliana
Vargiolu, Alessia
Elli, Francesca
Gritti, Paolo
Gaipa, Giuseppe
Belotti, Daniela
Basso, Gianpaolo
Zoerle, Tommaso
Stocchetti, Nino
Citerio, Giuseppe http://orcid.org/0000-0002-5374-3161
,
Funding for this research was provided by:
FRRB (“Unmet medical needs”, proposal number 3440227)
Italian Ministry of Health (Bando di Ricerca Finalizzata 2021, proposal number RF-2021-12372642)
Article History
Received: 26 May 2023
Accepted: 7 July 2023
First Online: 25 August 2023
Change Date: 29 October 2023
Change Type: Update
Change Details: The Funding declaration of this article has been corrected following original publication.
Declarations
:
: The MATRIx study obtained the Clinical Trial Authorization from the Italian Regulatory Agency (AIFA, Agenzia Italiana del Farmaco) on December 7, 2022 (Protocol number: 0141687—07/12/2022). The protocol and trial conduct will comply with the Medicines for Human Use (Clinical Trials) Regulations 2004 and any relevant amendments. The MATRIx trial was approved by the Ethics Committee of “Comitato Etico Brianza” on January 30, 2023 (n. 4083). Consent will be obtained according to Declaration of Helsinki guidelines and local regulations from each individual subject participating in this study and/or his/her legally designated representative/proxy. If the subject is not able to provide personal consent at the time the consent is obtained, then he/she must provide this consent as soon as possible once his/her clinical condition has improved to the extent that providing personal consent is possible, unless local regulations state otherwise.
: Not applicable.
: GC reports grants and personal fees as a Speakers’ Bureau Member and Advisory Board Member from Integra and Neuroptics, all outside the submitted work. ERZ is member of the InTBIR Executive Committee. All the other authors declare no competing interests.