Funding for this research was provided by:
Beaumont Health System
Text and Data Mining valid from 2018-08-24
Received: 12 February 2018
Accepted: 2 August 2018
First Online: 24 August 2018
Ethics approval and consent to participate
: Research ethics approval This protocol and the patient information sheet (Additional file InternalRef removed ) were reviewed and approved by the sponsor and the Institutional Review Board (IRB), Beaumont Hospital, Royal Oak, Michigan, United States, with respect to scientific content and compliance with applicable research and human subjects regulations.Any modifications to the protocol which may impact the conduct of the study and may potentially benefit the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample size, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendment will be approved by the IRB prior to implementation. The study protocol was reported based on current SPIRIT reporting guidelines for randomized controlled trails (Additional file InternalRef removed ).All ancillary testing is performed via the standard of care and no biological samples will be obtained or stored for future use. Confidentiality All study-related information will be stored securely at the study site in locked file cabinets and using secure database. Access to data All study personnel, including the principal investigator and the key personnel will be given access to the blinded data sets. Data will be stored on the Pharm-MD Sharepoint website created for the study, and all data sets will be securely protected.No specific provisions were made for ancillary or post-trial care, or for compensation to those who suffer harm from trial participation as there is little to no risk of harm.Upon completion of data collection, attempts will be made to reduce the interval between release of study results. We expect to take between 3 and 5 months to compile the final results in order to publish them. Regardless of the results, the study results will be released to the participating physicians, patients, and those in the medical community.Currently, the study has no data collected.
: Not applicable
: The authors declare that they have no competing interests.
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