Sultana, Janet http://orcid.org/0000-0001-9622-169X
Fontana, Andrea
Giorgianni, Francesco
Tillati, Silvia
Cricelli, Claudio
Pasqua, Alessandro
Patorno, Elisabetta
Ballard, Clive
Sturkenboom, Miriam
Trifirò, Gianluca
Funding for this research was provided by:
Ministero della Salute (GR-2009-607316)
Article History
First Online: 25 September 2019
Compliance with Ethical Standards
:
: Janet Sultana, Andrea Fontana, Francesco Giorgianni, Silvia Tillati, Claudio Cricelli, Alessandro Pasqua, Elisabetta Patorno, Clive Ballard and Miriam Sturkenboom have no financial relationships with any organisations that might have had an interest in the submitted work over the previous 3 years, or no other relationships or activities that could appear to have influenced the submitted work. Over the last 3 years, Gianluca Trifirò has attended advisory boards on topics not related to this paper, organized by Sandoz, Hospira, Sanofi, Biogen, Ipsen and Shire, and is a consultant for Otsuka. He is principal investigator at the University of Messina of observational studies funded by several pharmaceutical companies (Amgen, AstraZeneca, Daiichi Sankyo, IBSA), as well as scientific coordinator of the Masters program ‘Pharmacovigilance, Pharmacoepidemiology and Pharmacoeconomics: Real-World Data Evaluations’ at the University of Messina, for which he receives unconditional funding from several pharmaceutical companies, including Takeda, Teva, Almirall, Shire, Novartis, Roche, Otsuka and Zambon.
: This work was supported by a grant from the Italian Health Ministry held by Gianluca Trifiro’: [GR-2009-607316—Assessment of the Safety of Antipsychotic Drugs in Elderly with Dementia: An International, Population-Based Study Using Healthcare Databases. The funder played no role in study design, data collection, analysis and interpretation of data, in the writing of the report and in the decision to submit the article for publication.
: The use of THIN database was approved by the Cegidim Scientific Review Committee (SRC 13-085). Use of the Health Search—IQVIA Health LPD database was notified to the Ethics Committee of the University Hospital G. Martino of Messina. In Italy, full ethics approval is not required for retrospective observational studies with anonymised data. The authors declare that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008.
: The data that support the findings of this study are available from third parties, i.e. the Erasmus Medical Centre for THIN and the Italian Society of General Practitioners/IQVIA for Health Search—IQVIA Health LPD. However, restrictions apply to the availability of these data, which were used under license for the current study and are therefore not publicly available. However, data are available from the authors upon reasonable request and with permission of the Erasmus Medical Centre and the Italian Society of General Practitioners/IQVIA.