SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* Item Description No Administrative information Dedicated mobile application for drug Title 1 Descriptive title identifying the adverse reactions reporting by patients study design, population, with relapsing remitting multiple interventions, and, if applicable, sclerosis: study protocol for a trial acronym multicenter cluster-randomized controlled trial (Vigip-SEP study) TRIAL REGISTRTATION: Trial 2a Trial identifier and registry name. ClinicalTrials.gov, identifier: If not yet registered, name of NCT03029897. Registered 20 on intended registry January 2017. 2b All items from the World Health Yes Organization Trial Registration Data Set Approved version of VigiP-SEP is V3 Protocol 3 Date and version identifier version 29.11.2016, the recruitment began on June 2017, and the end date is anticipated in May 2018. The funding is provided by the Funding 4 Sources and types of financial, Regional Health Agency of material, and other support Normandy (ARS Normandie) and by the RBN-SEP Association, an association about multiple sclerosis. Funders have no implication in the collection, management, analysis, and interpretation of the data.
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents* Description Administrative information Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym Dedicated mobile application for drug adverse reactions reporting by patients with relapsing remitting multiple sclerosis: study protocol for a multicenter cluster-randomized controlled trial (Vigip-SEP study) Trial 2a Trial identifier and registry name. If not yet registered, name of intended registry TRIAL REGISTRTATION: ClinicalTrials.gov, identifier: NCT03029897. Registered on 20 January 2017. 2b All items from the World Health Organization Trial Registration Data Set Yes Protocol version 3 Date and version identifier Approved version of VigiP-SEP is V3 29.11.2016, the recruitment began on June 2017, and the end date is anticipated in May 2018. Funding 4 Sources and types of financial, material, and other support The funding is provided by the Regional Health Agency of Normandy (ARS Normandie) and by the RBN-SEP Association, an association about multiple sclerosis. Funders have no implication in the collection, management, analysis, and interpretation of the data. Item No
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