Received: 6 September 2020
Accepted: 16 September 2021
First Online: 26 September 2021
: For the current study, the historical documented data was further anonymized in coded fashion in order to protect patient confidentiality in accordance with local ethical or IRB guidelines, according to national and international standards for the conduct of clinical studies including 21 CFR Parts 50 and 56 and International Conference on Harmonization (ICH) E6-Good Clinical Practice Consolidated Guideline. Ethical clearance was not obtained as the study was carried out as a retrospective review of the available raw instrument and historical patient data, without any collection of extra specimen or monetary charges to patients and did not involve any communication of results of the study to the clinician, so as to affect the diagnostic and therapeutic management of the patients.
: Not applicable.
: JN and SR are employees of HORIBA Ltd. PD is an external consultant of HORIBA Ltd.