Received: 3 August 2021
Accepted: 18 November 2021
First Online: 4 January 2022
: The study was approved by the New England IRB (protocol number 120190313) and prospectively registered in ExternalRef removed, NCT04092946, 17/09/2019. This study was conducted in accordance with the approved guidelines. All patients were informed about the purpose and procedures of the study and provided informed consent.
: Not applicable.
: Fernando Correia, Fabíola Costa, Maria Molinos, Dora Janela and Virgílio Bento are employees at SWORD Health, the study sponsor. Gerard Francisco and Jorge Lains received a scientific advisor honorarium from SWORD Health.