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ViewClip: CropBox PrintArea: CropBox PageClip: CropBox PageLayout: SinglePage PageMode: UseNone Language: en-US Outlines: Item: Title: Study protocol for a randomised, double-­blinded, placebo-­controlled phase III trial examining the add-­on efficacy, cost–utility and neurobiological effects of low-­dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study) Children: Item: Title: Abstract Item: Title: Introduction Children: Item: Title: Fibromyalgia: definition, prevalence and pharmaceutical indications Item: Title: Pathogenesis of FMS Item: Title: Low-dose naltrexone (LDN): a promising treatment for FMS Item: Title: Methods and analysis Children: Item: Title: Trial design Item: Title: Sample size Item: Title: Eligibility criteria Children: Item: Title: General selection criteria Item: Title: Additional selection criteria for the biomarkers and neuroimaging substudy (50% of patients in each study arm) Item: Title: Recruitment strategy, procedure and randomisation Item: Title: Data management, central monitoring and audit Item: Title: Treatments Children: Item: Title: Low-dose naltrexone Item: Title: Placebo Item: Title: Study measures Item: Title: Measures for sociodemographic characteristics, clinical features and screening Item: Title: Primary outcome measure Item: Title: Secondary outcome measures Item: Title: Other measures Item: Title: Ecological momentary assessment Item: Title: Inflammatory biomarkers Item: Title: Neuroimaging Item: Title: Statistical analysis Item: Title: Patient and public involvement Item: Title: Ethics and dissemination Item: Title: Discussion Children: Item: Title: Trial status Item: Title: Confidentially Item: Title: References Info: Creator: Adobe InDesign 15.1 (Windows) Producer: Adobe PDF Library 15.0 CreationDate: Thu Jan 06 08:08:44 CET 2022 ModDate: Thu Jan 06 08:08:45 CET 2022 ID: 0x6ba0fbe2f1d491418db41c5f77be6230, 0xc1cf4ac04d039d47bca782de084a7d6f Filters: FilterPipeline: FlateDecode Images: Image: NisoImageMetadata: 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