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Question Text Author Response Custom
Submission Question ID
Please complete the following questions inaccordance with the International Committee of Medical Journal Editors' recommendations on data sharing in clinical trials (guidelines and examples are available here
Will individual participant data be available (including data dictionaries)?
Yes 54
What data in particular will be shared?
(Examples include all individual participant data after deidentification, only participant data that underlies the results, or not available.)
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
55
What other documents will be available? Study Protocol, Statistical Analysis Plan (SAP) 56 When will data be available (start and end dates)? Beginning 9 months and ending 36 months following
article publication or as required by a condition of awards and agreements supporting the research.
57
With whom? (Examples include anyone who wishes to access the data, researchers who provide a proposal, or not applicable.)
The investigator who proposed to use the data and upon reasonable request.
58
For what types of analyses? Upon reasonable request. 59
By what mechanism will data be made available? Requests should be directed to
[email protected]. To gain access, data requestors will need to sign a data access agreement.
60