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Sustained disability improvement is associated with T1 lesion volume shrinkage in natalizumab-treated patients with multiple sclerosis

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  • Contributors LP: study design, data analysis and interpretation, manuscript drafting; FDA: MRI data collection and analyses, manuscript revising; RDA: MRI data collection and analyses; FF: clinical data collection, manuscript revising; CP: study design, data interpretation, manuscript revising.

  • Funding This research was supported by Biogen Idec.

  • Competing interests LP has received consulting fees from Merck Serono, Bayer Schering and Biogen Idec, and speaker honoraria from Biogen Idec, Teva and Novartis. CP has received consulting and lecture fees from Sanofi-Aventis, Biogen Idec, Bayer Schering, Merck Serono, and Novartis; he also received research funding from Sanofi-Aventis, Merck Serono, Bayer Schering and Novartis. FDA, RDA and FF have nothing to disclose.

  • Patient consent Obtained.

  • Ethics approval This study was conducted in accordance with the International Conference on Harmonization Guidelines of Good Clinical Practice and the Declaration of Helsinki. In no way did this study interfere in the Care received by patients. The Ethical Committee of Sapienza University (President Prof. Aldo Isidori, Viale del Policlinico, 155, 00161 Roma, tel. +39-6-4453395, fax +39-6-4455345) provided exemption of approval for post-authorisation observational studies. Each patient involved in this study signed an informed consent before collecting, storing and analysing individual data.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement An anonymised dataset is available as a supplementary file for readers.