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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 including baseline demographic variables and the shortened Disabilities of the Arm, Shoulder and Hand questionnaire scores at baseline and after completion of the 2 month training period; along with the data dictionary and the study protocol
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When the data will become available and for how long
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Access will start 6 months after publication of the main results and will remain available for 5 years
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To whom data/document is available
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Researchers from universities and scientific centers who has specific scientific aims
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Under which criteria data/document could be used
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Use is permitted only for scientific purposes such as meta analysis, systematic reviews, and secondary analyses related to the study objectives; only de identified data will be shared; requestors must sign a data use agreement, agree not to attempt re identification, not to share data with third parties, and to cite the trial registration in any resulting publications
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From where data/document is obtainable
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Requests should be sent to the principal investigator: Ali Moradi, email Ali.moradi206@gmail.com
, mobile 0098 9359385871
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What processes are involved for a request to access data/document
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Requestors submit a written application including the proposed project title, objectives, analysis plan, and institutional details; the research team reviews the request; if approved, a data use agreement is signed and the de identified dataset, data dictionary, and protocol are provided electronically
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Comments
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The informed consent form will not be publicly shared due to confidentiality and research ethics considerations