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Article History

Received: 9 August 2019

Accepted: 16 December 2019

First Online: 1 January 2020

Compliance to ethical standards

:

: F. Lapi provided consultancies in protocol preparation for epidemiological studies and data analyses for Pierre Fabre. V. Pegoraro, N. Cataldo and F. Heiman, all received grants from Pierre Fabre, Astellas, Astra Zeneca, Bayer, DOC Generici, Helsinn, Hisamitsu, Kyowa, Lundbeck, Merck Serono, Novartis, Otsuka, Pfizer, Recordati. C. Cricelli provided clinical consultancies for Pierre Fabre. M. Levi, D. L. Vetrano, A. Zucchelli, and E. Marconi have no conflict of interest to disclose.

: According to a by-law on the implementation of observational drug-related research, issued by the Italian National Drug Agency (belonging to the Italian Ministry of Health), the present study does not require approval by an ethics committee (Italian Drug Agency not of 3 August 2007).

: This observational study has been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. No animals have been involved.

: No informed consent was required in accordance with an Italian by-law on observational drug-related research.