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Article History

Received: 5 November 2024

Accepted: 23 July 2025

First Online: 29 September 2025

Declarations

:

: The Milan 1 study was conducted at the Istituto Nazionale per lo Studio e la Cura dei Tumori in Milan, Italy, commencing in 1973. The ethical conduct of the study was guided by the principles of the Declaration of Helsinki. While a formal Institutional Review Board as currently structured may not have been in place at the study’s inception, the protocol would have undergone rigorous internal review at the institution. All participants would have provided informed consent to participate in the trial after a thorough explanation of the randomized treatment arms. The Milan 3 study was conducted at the Istituto Nazionale per lo Studio e la Cura dei Tumori in Milan, Italy, between 1987 and 1989. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. The study protocol was subject to review and approval by the institutional ethics committee of the Istituto Nazionale per lo Studio e la Cura dei Tumori. Informed consent was obtained from all participants before their inclusion in the trial.

: Not applicable. This study is a secondary analysis of historical data from the Milan I and Milan III clinical trials. All data used for this analysis were fully de-identified prior to being accessed by the authors. The manuscript does not contain any images, case details, or other information that could lead to the identification of an individual participant.

: Data is not publicly available. The R code for the analysis is available under request to the corresponding author.

: The authors declare no competing interests.

: No funding was received for the present work.