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Article History

Received: 15 December 2017

Accepted: 8 October 2018

First Online: 29 November 2018

Ethics approval and consent to participate

: Ethical approval for this trial was obtained from the Ethics Committee of “Istituto Auxologico Italiano” (V.0.4 30-05-2017). The study personnel and the Ethics Committee will ensure that the study is conducted within appropriate professional ethical guidelines and that Good Clinical Practice guidelines are observed. All participants provide written informed consent before participating in the trial or extension study.

: Not applicable.

: The authors declare that they have no competing interests.

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