Funding for this research was provided by:
Novartis Farma SpA
Text and Data Mining valid from 2019-11-06
Received: 17 June 2019
Accepted: 22 October 2019
First Online: 6 November 2019
Ethics approval and consent to participate
: The PROXIMA study was conducted in accordance with the ethical principles laid down in the Declaration of Helsinki and the AIFA Guideline for classification and management of observational studies on drugs. All patients provided written informed consent before participating in the study. The study documents including protocol and informed consent forms were approved by the ethics committees and institutional review boards of all participating centers.
: Not applicable.
: CD is a part-time employee of Novartis Farma Italy and received grants from Allergan and Aventis. ZE is an employee of Novartis Farma Italy. FF is an employee of Medineos Observational Research (Modena, Italy). GWC received research grants as well as lecture or advisory board fees from A. Menarini, AstraZeneca, Boehringer Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, Glaxo Smith Kline, Mundipharma, Novartis, Sanofi-Aventis, Teva.