Trial design and ethical aspects
This study was a prospective, randomised, parallel, double-blind, and placebo-controlled clinical trial (EudraCT number: 2017–002,168-42). It was approved by the Committee for the Ethics of Research with Medicines of Euskadi (CEIm-E) on 31 October 2018 (internal code number: 201862) and the Spanish Agency of Medicines and Medical Devices (AEMPS) on 18 December 2018. This study was conducted in accordance with ethical principles, including the World Medical Association Declaration of Helsinki (World Medical Association, 2013) and the Consolidated Standards of Reporting Trials (CONSORT) statement [