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Article History

Received: 11 May 2021

Accepted: 8 November 2021

First Online: 21 November 2021

Declarations

:

: Central ethical approval has been confirmed from the EKNZ, and local ethical approval has been obtained from ethical review board of the University of Thessaly. The intervention study was registered in the WHO trial register (trial number: ISRCTN16291983). All participants will be informed about the general goals of the study. Informed written consent is required before study entry. On the consent form, participants will be asked if they agree to use of their data should they choose to withdraw from the trial. Participants will also be asked for permission for the research team to share relevant data with people from the universities taking part in the research or from regulatory authorities, where relevant. They will also be informed that the trial involves collecting blood specimen (10 drops) from every individual at each measurement occasion. The study will be carried out in accordance with the ethical principles laid down in the Declaration of Helsinki (1964). Important protocol modifications will be communicated to participants and trial registers.

: After completion of the data assessment, all personal data of the participants will be encoded (each participant will receive a project ID-number), so that it will no longer be possible to identify the participants. No publication of case reports is planned where the manuscript could contain individual person’s data.

: The authors declare that they have no competing interests.