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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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Yes - There is 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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No - There is not 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 participant-level data underlying the reported results will be shared, including group allocation and executive-function scores at baseline, post-intervention, and 30-day follow-up. Names, contact details, and other identifying information will be removed.
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When the data will become available and for how long
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Data will be available upon reasonable request from six months after publication of the main study results for a period of five years.
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To whom data/document is available
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Qualified researchers from academic, scientific, or industry institutions will be eligible to request access. Access will require an approved research proposal and a signed data-use agreement protecting participant confidentiality.
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Under which criteria data/document could be used
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Data will be used only for approved secondary analyses, verification of findings, or meta-analyses. Requests will specify the research aim, required variables, and analysis plan. Users will maintain secure storage, make no attempt to identify participants, and neither redistribute the data nor use them beyond the approved purpose.
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From where data/document is obtainable
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Requests will be submitted by email to Fatemeh Mirzaei at solalll.19966@gmail.com. Applicants will provide their name, institutional affiliation, research proposal, required data, and analysis plan
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What processes are involved for a request to access data/document
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Applicants will email Fatemeh Mirzaei at solalll.19966@gmail.com, providing their institutional affiliation, research aim, required data, and analysis plan. Requests will be reviewed within four weeks. Following approval and signing of a data-use agreement, de-identified data will be transferred securely within two weeks. For complete requests, the entire process will take up to six weeks.
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Comments
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