Cossyleon, Ricardo
Robinson, Kathy
Delfino, Kristin
Robbins, K. Thomas
Rao, Krishna
Article History
Received: 26 April 2023
Accepted: 20 December 2023
First Online: 9 January 2024
Declarations
:
: This project was approved by SIU Medicine IRB (IRB protocol 18–312) to perform a retrospective analysis of the survival/relapse data and patient outcome data available from a previous study (IRB protocol 05–142) approved by the Springfield Committee for Research Involving Human Subjects (SCHRIS), submitted to the FDA under IND number 74,135, and registered at clinicaltrials.gov with number NCT00304278. We conducted all procedures following the regulations established by SCRIHS and the Code of Federal Regulations, 20CFR Part 46.
: All patients were consented for the collection of questionnaires and patient-reported outcomes under protocol 05–142 in accordance with 20 CFR Part 50. Updated survival and relapse data were collected under protocol 18–312 with a waiver of informed consent.
: The authors declare no competing interests.