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Article History

Received: 12 April 2019

Accepted: 21 November 2019

First Online: 15 January 2020

Ethics approval and consent to participate

: This study will be conducted in accordance with the good clinical practice guidelines promulgated by the International Conference on Harmonization, the principles of the Declaration of Helsinki, and the Medical Research Involving Human Subjects Act. The NICE-PD study protocol and communication materials have been approved by the local ethics committee (Commissie Mensgebonden Onderzoek Arnhem-Nijmegen; NL65468.091.18). The study is registered with the registry (identifier NCT03830190) []. The trial results will be reported according to the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines [].When a patient meets the inclusion criteria, informed consent will be obtained by the research team after the team explains the procedures and requirements of the study, how subjects’ confidentiality will be maintained, and any potential hazards/risks. Each patient will sign an informed consent form in person at the baseline visit before baseline assessment takes place. The researcher will sign the informed consent immediately after the patient has signed it. The researcher provides a copy of the signed informed consent form to each participant and keeps a copy in the participant’s study file.When important changes are made to the study protocol (e.g., changes in eligibility criteria, outcomes, or statistical analyses), the principal investigator will notify relevant parties about these changes, and a copy of the revised protocol will be sent to these parties (e.g., the ethics committee, participating centers, and the clinical trial registry). Furthermore, the updated protocol will be included in the trial registry.

: Not applicable.

: BRB and MM were supported by a research grant from the Parkinson’s Foundation and the Gatsby Foundation. DLMR, HHL, and NMdV were supported by a research grant from ZonMw (The Netherlands Organisation for Health Research and Development) and Zambon. HV, TvA, CCSD and RHH declare that they have no competing interests.