Date

2019-02-11

Protocol

No protocol changes

Item Changed

IPD sharing plan description

Previous Version

(Blank) Note: this data field was not available at the time of trial registration

Next Version

Individual participant data that underlie the results will be shared after the de-identification (tables,figures,appendices). This will be immediately following publication (no end date). Data sharing will be with investigators whose proposed use of the data has been approved by an independent review committee/ethical review committee identified for this purpose, to achieve the aims of the approved proposal. Proposals should be directed to dhananjachami@gmail.com and ajithalagie@yahoo.com.