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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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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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Data related to toll-like receptor 4 (TLR4), matrix metalloproteinase 9 (MMP-9), interferon-gamma (IFN-γ), interleukin 4 (IL-4), fasting blood sugar (FBS), lipid profile (cholesterol, HDL, LDL), and body composition of participants.
Details: The individual data includes laboratory results and physical measurements (using standard devices). All data will be shared after de-identifying the participants (removal of names and identifying information). Data related to primary outcomes (inflammatory markers and lipid profile) will be available for sharing. Only personal identifiable data or confidential information will be excluded from sharing.
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When the data will become available and for how long
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Access to the data will start six months after the publication of the study results. The access period will continue for three years after the starting date.
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To whom data/document is available
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The data will be available only to researchers affiliated with academic and research institutions who submit an official request. Individuals working in industry or private companies will not have access to the data.
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Under which criteria data/document could be used
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The data may only be used for scientific and research analyses. Commercial use or publication without prior written permission is prohibited. Applicants must submit an official request including a description of the research purpose and the intended analyses. A confidentiality agreement must be signed by the applicants. Access will be granted only after approval by the research committee.
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From where data/document is obtainable
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Applicants must contact Dr. Fatemeh Shabkhiz exclusively to request access to the data. All requests must be formally submitted via email to:
fatemeh.shabkhiz@ut.ac.ir
For postal correspondence, requests should be sent to:
Faculty of Physical Education and Sport Sciences, University of Tehran, North Kargar Street, above Jalal Al-Ahmad intersection, between 15th and 16th Streets, opposite the University of Tehran dormitory, Tehran, Postal Code: 1417466191.
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What processes are involved for a request to access data/document
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After submitting a formal request to Dr. Fatemeh Shabkhiz, the request will be reviewed within 10 working days. If approved by the research committee, the applicant must sign a data confidentiality agreement. After signing the agreement, the data will be provided to the applicant within a maximum of 15 working days. If the request is rejected, the reason for rejection will be formally communicated to the applicant.
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Comments
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