Author Contributions: Ms Sanchini had full
access to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Sanchini, Nanni.
Acquisition of data: Sanchini, Gunelli, Fabbri,
Sermasi, Bercovich, Ravaioli, Amadori, Calistri.
Analysis and interpretation of data: Sanchini,
Drafting of the manuscript: Sanchini, Gunelli,
Bercovich, Ravaioli, Calistri.
Critical revision of the manuscript for important
intellectual content: Sanchini, Nanni, Bravaccini, Fabbri, Sermasi,
Statistical analysis: Sanchini, Nanni.
Obtained funding: Sanchini, Amadori, Calistri.
Administrative, technical, or material support:
Sanchini, Gunelli, Bravaccini, Fabbri, Sermasi, Bercovich, Ravaioli, Amadori,
Study supervision: Sanchini, Calistri.
Financial Disclosures: None reported.
Funding/Support: This work was supported by
Istituto Oncologico Romagnolo, Forlì and the National Research Council
(Consiglio Nazionale delle Ricerche [National Research Council]–Ministero
dell’Istruzione, dell’Universita e della Ricerca [Ministry of
Education, University and Research] “Oncologia”; grants 02.00082.ST97
Role of the Sponsor: Istituto Oncologico Romagnolo
and the National Research Council supplied the funding but did not participate
in the design and conduct of the study; in the collection, management, analysis,
and interpretation of the results; or in the preparation, review, or approval
of the manuscript.
Independent Statistical Analysis: Independent
statistical analysis was performed by Oriana Nanni, MSc, at the Unit of Biostatistics
and Clinical Trials of Istituto Oncologico Romagnolo, Forlì, Italy.
Acknowledgment: We thank Rosella Silvestrini,
PhD, Istituto Oncologico Romagnolo, for her invaluable scientific contribution
and Gráinne Tierney, BSc, Division of Oncology and Diagnostics, Morgagni-Pierantoni
Hospital, Forlì, for editing the manuscript. We also thank Giuliana
Amadori, RN, of the Department of Geriatrics, Morgagni-Pierantoni Hospital,
for assistance in sample collection. None of those acknowledged received compensation
from the study sponsors.