Quality
The Investigational New Drug (IND) application for this study was approved by the FDA. The study was approved by the Johns Hopkins University Institutional Review Board. All patients (or their legal representatives) gave written informed consent before enrollment. The study was conducted in accordance with the Declaration of Helsinki and the International Council for Harmonization Good Clinical Practice guidelines and monitored externally by the SKCCC Clinical Research Office and Safety Monitoring Committee.The SKCCC was the IND sponsor of this study and was responsible for study design, data collection, analysis, and result interpretation. All the authors attest to the fidelity of trial conduct to its protocol, vouch for the accuracy and completeness of the data, and decided to submit the article for publication. The manufacturer of Helixor-M provided study drugs and information for the IND but played no role in the study design, execution, or result interpretation.