definiens: De - identification ' " mean removal of information that identifies individuals in a manner that conforms with applicable laws, 1,3 means the date when this Addendum IS effective as stated in the preamble : 1.4 means, for the purpose of thiS Addendum, any patient selected who ( I ) meets the criteria for participating In Phase 28 Study or the Phase 3 Portion, as the case may be, ( ii ) who has signed the corresponding approved patient informed consent form . and ( Iii ) who has signed the [COMPANY] CareLink network enrolment consent form in accordance with the terms of use between the Investigational site In Europe using CareLink network services for the commercial use of [COMPANY] Devices and the [COMPANY] Affiliate that provides CareLlnk in the country in which the investigational site IS located, 1.5 means any applicable federal . provincial, local or other governmental body with Jurisdiction over the applicable subject matter