Funding agencies: The sponsor, Newron Pharmaceuticals S.p.A., was responsible for the study design, investigator selection, general oversight of the trial, and identification of the contract research organization responsible for day-to-day study management, monitoring, data management, and statistical analysis. Professor Pablo Martinez-Martin provided training for the UPDRS. The interpretation of the data and preparation of the manuscript were performed by the authors with the assistance of an independent medical writing agency, funded by Merck Serono. The decision to submit to Movement Disorders was made by the authors.
Version of Record online: 12 SEP 2011
Copyright © 2011 Movement Disorder Society
Volume 27, Issue 1, pages 106–112, January 2012
How to Cite
Stocchi, F., Borgohain, R., Onofrj, M., Schapira, A. H.V., Bhatt, M., Lucini, V., Giuliani, R., Anand, R. and for the Study 015 Investigators (2012), A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients. Mov. Disord., 27: 106–112. doi: 10.1002/mds.23954
Relevant conflicts of interest/financial disclosures: F.S. and all the other participants of the clinical study received payment according to the number of patients included in the trial. F.S. has received honoraria for educational symposia and consultancy for Newron and Merck Serono. A.H.V.S. has received honoraria from Merck Serono for medical education symposia and for providing advice in the development of safinamide. R.A. has received honoraria for acting as a consultant for Newron Pharmaceuticals in the development of safinamide, in the conception and organization of this clinical trial, in the statistical design and critical review of the analysis, and in the conception, review, and critique of the manuscript for this article. M.O. has received honoraria for acting as a consultant for Newron Pharmaceuticals and from Merck Serono for an educational symposium. V.L. and R.G. are employees of Newron. R.B. and M.B. have nothing else to disclose.
Full financial disclosures and author roles may be found in the online version of this article.
- Issue online: 13 JAN 2012
- Version of Record online: 12 SEP 2011
- Manuscript Accepted: 14 AUG 2011
- Manuscript Revised: 29 JUL 2011
- Manuscript Received: 25 MAR 2011
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