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Title:           Comparison of the effectiveness of first-line preventive treatment of migraine in primary care: study protocol for a pragmatic clinical trial (PREMI study)
Subject:         Trials, https://doi.org/10.1186/s13063-025-08961-0
Keywords:        Migraine;Monthly Migraine Days (MMD);Randomized Clinical Trial;Preventive Treatment;Primary Care;Adherence;Patient Reported Outcomes Measures (PROM)
Author:           Maria Giner-Soriano 
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      Title: Comparison of the effectiveness of first-line preventive treatment of migraine in primary care: study protocol for a pragmatic clinical trial (PREMI study)
      Children: 
       Item: 
        Title: Abstract 
        Children: 
         Item: 
          Title: Background 
         Item: 
          Title: Methods 
         Item: 
          Title: Discussion 
         Item: 
          Title: Trial registration 
       Item: 
        Title: Introduction
        Children: 
         Item: 
          Title: Background and rationale
         Item: 
          Title: Objectives
         Item: 
          Title: Trial design
       Item: 
        Title: Methods: participants, intervention, and outcomes
        Children: 
         Item: 
          Title: Study setting
         Item: 
          Title: Eligibility criteria
         Item: 
          Title: Who will take informed consent?
         Item: 
          Title: Additional consent provisions for collection and use of participant data and biological specimens
       Item: 
        Title: Interventions
        Children: 
         Item: 
          Title: Explanation for the choice of comparators
         Item: 
          Title: Intervention description
         Item: 
          Title: Criteria for discontinuing or modifying allocated interventions
         Item: 
          Title: Strategies to improve adherence to interventions
         Item: 
          Title: Relevant concomitant care permitted or prohibited during the trial
         Item: 
          Title: Provisions for post-trial care
         Item: 
          Title: Outcomes
         Item: 
          Title: Participant timeline
         Item: 
          Title: Sample size
         Item: 
          Title: Recruitment
       Item: 
        Title: Assignment interventions: allocation
        Children: 
         Item: 
          Title: Sequence generation
         Item: 
          Title: Concealment mechanism
         Item: 
          Title: Implementation
       Item: 
        Title: Assignment interventions: Blinding
       Item: 
        Title: Data collection and management
        Children: 
         Item: 
          Title: Plans for assessment and collection of outcomes
         Item: 
          Title: Plans to promote participant retention and complete follow-up
         Item: 
          Title: Data management
         Item: 
          Title: Confidentiality
         Item: 
          Title: Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trialfuture use
       Item: 
        Title: Statistical methods
        Children: 
         Item: 
          Title: Statistical methods for primary and secondary outcomes and methods for additional analyses
         Item: 
          Title: Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data
         Item: 
          Title: Plans to give access to the full protocol, participant level data and statistical code
       Item: 
        Title: Oversight and monitoring
        Children: 
         Item: 
          Title: Composition of the coordinating centre and trial steering committee
         Item: 
          Title: Composition of the data monitoring committee, its role and reporting structure
         Item: 
          Title: Adverse event reporting and harms
         Item: 
          Title: Frequency and plans for auditing trial conduct
         Item: 
          Title: Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees)
         Item: 
          Title: Dissemination plans
       Item: 
        Title: Discussion
       Item: 
        Title: Trial status
       Item: 
        Title: Appendix
       Item: 
        Title: Acknowledgements
       Item: 
        Title: References
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