Author Contributions: Drs Nicolucci and Balducci contributed equally to this work. All authors had access to all the data in the study and take full responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Nicolucci, Balducci, Zanuso, and Pugliese. Acquisition of data: Nicolucci, Balducci, Cardelli, Zanuso, and Pugliese. Analysis and interpretation of data: Nicolucci, Balducci, Cardelli, Zanuso, and Pugliese. Drafting of the manuscript: Pugliese. Critical revision of the manuscript for important intellectual content: Nicolucci, Balducci, Cardelli, and Zanuso. Statistical analysis: Nicolucci. Obtained funding: Balducci. Administrative, technical, and material support: Balducci and Zanuso. Study supervision: Balducci and Pugliese.
Financial Disclosure: None reported.
Funding/Support: This work was supported by Lifescan SrL, Novo Nordisk Ltd, Bristol Myers Squibb Italy, Technogym SpA, and Cosmed SrL.
Role of the Sponsors: The sponsors had no role in design and conduct of the study; collection, management, and interpretation of the data; or preparation, review, and approval of the manuscript.
Trial Registration: isrctn.org Identifier: ISRCTN04252749
Additional Contributions: Stefano Cavallo, MD, Sara Fallucca, PhD, Alessandra Bazuro, MD, Paola Simonelli, MD, and Carla Iacobini, PhD, from the Department of Clinical and Molecular Medicine, “La Sapienza” University, Rome, Italy, participated in the acquisition of data and critical revision of the manuscript.