Design
MAY
This was a single-center, double-blind, three parallel group, block randomized, placebo-controlled trial, followed by an open phase conducted at Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden, between October 2021 and February 2022. The study was conducted according to the Declaration of Helsinki and ethically approved by the Swedish Ethical Review Authority in May 2021 (file no. 2021-02383 with amendment no. 2021-06174-02) and registered at ClinicalTrials.gov (NCT04897698) on 21/05/2021. The study followed CONSORT guidelines for trials.