This is a prospective, multicenter, randomized controlled trial. The study consists of 3 phases as follows:
* Randomization phase: subjects undergo screening, baseline, interim and 90-day follow-up visits
* PKG+ Group (standard of care clinical evaluation plus use of PKG data)
* PKG- Group (standard of care clinical evaluation without use of PKG data - the MDS is blinded to PKG data)
* Randomization ratio will be 1:1 with assignments generated in advance of the start of the trial by the unblinded statistician who will provide a list containing group assignments that will be available in an Electronic Database (EDC) for site use.
* The clinical investigator, study site staff, and subject will not be blinded to the randomization assignment during the randomization phase of the study
* Open-label phase: at the end of the 90-day randomization phase visit for PKG- Group subjects, the MDS will report on the PKG and review it with the subject, the subject will complete follow-ups with the MDS using the PKG information during the clinical assessment following the same process as the PKG+ Group during the randomization phase
* Extended open-label follow-up phase: annual follow-ups for all subjects at 1, 2, and 3 years during which the MDS will use the PKG information during clinical assessments for all subjects.
