Who will take informed consent? {26a}
Receipt of a signed and dated informed consent form is required for inclusion in the trial. A trial investigator or delegate will obtain informed, freely given written consent from each patient via a consent form, after confirming that the patient understands the content of the form. The investigator or delegate will then sign and date the consent form. If a trial collaborator has given a supplementary explanation to the patient, the trial collaborator will also sign and date the consent form.