Document is current

Article History

Received: 14 June 2017

Accepted: 28 January 2018

First Online: 6 February 2018

Ethics approval and consent to participate

: In all of the trials that generated the data included in this database, study protocols were approved by the participating medical centers and all participating patients gave informed consent. De-identified data from these trials were donated to the PRO-ACT database for research purposes only and under the explicit conditions that Prize4Life and all users of the data would maintain the anonymity of subjects and not attempt to discover the identity of any subject. In the rare cases where donated data was not already completely anonymized, donated data was further anonymized following the HIPAA de-identification conventions for personal health information: any potential patient initials and/or dates of birth were removed, new randomized subject numbers were created, and wherever possible, trial-specific information was removed in the merging of datasets, including trial center identity and location, trial dates, or other identifying information. This project was deemed not to constitute human subjects research and the need for ethical approval for this work was waived by the University of Kansas Medical Center’s Human Research Protection Program.

: Not applicable

: Jeffrey M. Statland is a consultant for aTyr, Acceleron, Fulcrum, Regeneron, and Strongbridge. The remaining authors declare that they have no competing interests.

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