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Articles Randomized trials in The Lancet: formatting guidelines To assist authors with submission and to streamline the peer review and editing process, we have compiled the following guidance for
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Start by clearly defining the purpose and objectives of the randomized trial. Clearly state the research question or hypothesis that you intend to investigate.
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Conduct a comprehensive literature review to identify and understand the existing research on the topic. This will help you determine the current knowledge gaps and avoid duplicating previous studies.
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Design the study protocol, including the selection criteria for participants, randomization procedures, intervention or treatment protocols, outcome measures, and statistical analysis plan. Ensure that your study design adheres to ethical considerations and is in line with relevant guidelines and regulations.
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Obtain any necessary ethical approvals or permissions from relevant authorities or ethics committees before initiating the trial.
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Recruit participants based on the predetermined selection criteria and obtain informed consent from each participant. It is important to ensure that the study population is representative and diverse enough to generate meaningful results.
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Implement the intervention or treatment according to the study protocol and monitor its administration or delivery. Collect data on relevant outcomes systematically and consistently.
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Analyze the collected data using appropriate statistical methods. This may involve comparing different treatment groups or assessing the impact of the intervention on various outcomes. Ensure that the statistical analysis plan is predefined to avoid any bias and maintain the integrity of the results.
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Prepare a comprehensive and concise manuscript summarizing your randomized trial, adhering to the guidelines of the targeted journal or publication. Follow the required structure, including sections such as introduction, methods, results, discussion, and conclusion.
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Submit your manuscript for peer review, addressing any feedback or revisions suggested by the reviewers. Once accepted, your article will contribute to the body of knowledge in the field of randomized trials and help inform future research and evidence-based practice.

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Articles randomised trials are studies in which participants are randomly assigned to different groups.
Researchers conducting randomised trials are required to file articles.
Articles randomised trials can be filled out by providing detailed information about the study design, participants, interventions, outcomes, results, and conclusions.
The purpose of articles randomised trials is to provide evidence-based information on the effectiveness of interventions and treatments.
Information that must be reported on articles randomised trials includes study design, participant characteristics, interventions, outcomes, results, and conclusions.
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