Novak, Matthew D.
Holtyn, August F.
Toegel, Forrest
Rodewald, Andrew M.
Leoutsakos, Jeannie-Marie
Fingerhood, Michael
Silverman, Kenneth
Funding for this research was provided by:
National Institute of Allergy and Infectious Diseases (R01AI117065)
National Institute on Drug Abuse (T32DA07209)
Article History
Accepted: 8 December 2023
First Online: 20 December 2023
Declarations
:
: The Johns Hopkins Medicine Institutional Review Board approved the study and all procedures were in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was monitored by a Scientific Advisory Committee. Staff members reported all events that might be considered adverse events, including deaths, and the investigators determined if any events met the definitions of adverse events as defined by the Johns Hopkins Medicine Institutional Review Board. The investigators, the Scientific Advisory Committee and the Johns Hopkins Medicine Institutional Review Board reviewed all adverse events annually. We registered the trial on Clinicialtrials.gov before recruitment began (NCT02363387). All participants provided written informed consent at enrollment.
: Not applicable.
: The authors declare no conflicts of interests.