Saba, Luca
De Rubeis, Gianluca
Pisu, Francesco
Article History
Received: 6 November 2024
Accepted: 11 July 2025
First Online: 18 July 2025
Declarations
:
: We obtained access to the data through authorized channels from the National Heart, Lung, and Blood Institute (NHLBI), specifically from the ROMICAT-II trial (BioLINCC RMDA V02 1d20120806). The original trial received ethics approval from the relevant institutional review boards, and all participants provided written informed consent. Our secondary analysis was approved under the data use agreement established with NHLBI.
: Not applicable. This study is a secondary analysis of anonymized data from a publicly available dataset (ROMICAT-II) and does not include any individual-level data or images requiring consent for publication.
: LS: none. GDR: none. FP: none.Transparency declarationThe author affirms that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.