Ethics approval and consent to participate
ICH
Patients voluntarily agreed to participate by giving written informed consent. This study was conducted in full conformance with the ICH E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki. Ethics Committee: Melbourne Health Human Research Ethics Committee. • NMA Reference Number: HREC/15/MH/334. • eCTN number: CT-2015-CTN-02675-1 v1.