Sidhaye, Venkataramana K. http://orcid.org/0000-0002-4506-8549
Holbrook, Janet T.
Burke, Alyce
Sudini, Kuladeep R.
Sethi, Sanjay
Criner, Gerard J.
Fahey, Jed W.
Berenson, Charles S.
Jacobs, Michael R.
Thimmulappa, Rajesh
Wise, Robert A.
Biswal, Shyam
Funding for this research was provided by:
National Heart, Lung, and Blood Institute (5U01HL105569, HL124099)
Article History
Received: 24 April 2019
Accepted: 13 August 2019
First Online: 20 August 2019
Ethics approval and consent to participate
: The clinical trial was approved by the Institutional Review Board (IRB) at each center; participants signed consent statements approved by the local IRB. The institutional review committees were: IRB-FC at Johns Hopkins Bloomberg School of Public Health for the data coordinating center and central laboratories, and IRB-2 at Johns Hopkins Medicine, Medical Interventions Committee A1 at Temple University, and the Buffalo VA Medical Center IRB for the 3 clinical centers, respectively; The trial was conducted under an Investigational New Drug Exemption (#109233) and was registered at ExternalRef removed (NCT01335971). This report adheres to Consolidated Standards of Reporting Clinical Trials (CONSORT) guidelines for clinical trials (S1 CONSORT Checklist). The study is registered on ExternalRef removed and data from the trial have been deposited in the BioLINCC repository (ExternalRef removed). Informed concent was obtained for every patient enrolled and the details are described in the trial manuscript.
: Not applicable.
: The authors declare that they have no competing interests.