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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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De-identified individual participant data. The dataset will include demographic characteristics, baseline data, primary and secondary outcome measures, and variables required to reproduce the study findings. All personal identifiers will be removed prior to data sharing. Data will be available after publication of the primary study results upon reasonable request, submission of a scientific rationale, and approval by the corresponding author.
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When the data will become available and for how long
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After publishing the paper
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To whom data/document is available
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Researchers, faculty members, graduate students, research institutions, academic centers, and other applicants with legitimate scientific and research purposes may request access to the study data and documents. Requests will be reviewed based on the intended use of the data and will be granted upon approval by the corresponding author and in accordance with ethical and confidentiality requirements.
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Under which criteria data/document could be used
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The study data and documents may be used solely for scientific, research, and educational purposes. Applicants must provide a written description of the intended use of the data, research question, analytical approach, and planned use of the documents. The data may not be used to identify participants, for commercial purposes, transferred to third parties without permission, or used in any manner inconsistent with research ethics principles. All data will be provided in a de-identified format, and recipients will be required to maintain confidentiality and appropriately acknowledge the original study in all reports and publications arising from the shared data.
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From where data/document is obtainable
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contacting the corresponding author
mirlohianm@gmail.com
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What processes are involved for a request to access data/document
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Applicants should submit their requests by email to the corresponding author. The request should include the applicant’s details, institutional affiliation, the purpose of the data or document use, the research question, and the analysis plan. Requests will be reviewed for scientific merit, ethical considerations, and confidentiality requirements. A decision will be communicated within 4 weeks. If approved, the requested data or documents will be provided in an appropriate format after removal of all identifying information and shared via email or another secure transfer method.
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Comments
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