Received: 13 August 2020
Accepted: 25 May 2021
First Online: 9 June 2021
: The study protocol and amendment were reviewed by an Independent Ethics Committee (IEC) for each trial site. Further details regarding each IEC involved in this study can be found in Additional file InternalRef removed.Participants or their legally acceptable representatives provided their written consent to participate in the study after having been informed about the nature and purpose of the study and participation/termination conditions. A separate informed consent form was also signed by the participant’s designated carer (an unpaid carer, family member, significant other, or friend) with knowledge of the participant, who was willing to complete the relevant questionnaire.
: Not applicable.
: KP, CV, ML and AW are employees of Janssen and Johnson & Johnson stockholders. CM is an employee of Janssen.JA reports personal fees from Janssen-Cilag during the conduct of the study; grants and personal fees from Janssen-Cilag and Boehringer Ingelheim, personal fees from Eisai and Otsuka - Lundbeck, and grants from Lundbeck outside the submitted work.KL reports grants and personal fees from Janssen-Cilag during the conduct of the study; grants and personal fees from Otsuka and Janssen-Cilag, and personal fees from Recordati and Lundbeck outside the submitted work.SP reports personal fees from Janssen during the conduct of the study; personal fees from Janssen, Sunovion and Recordati outside the submitted work.PS reports personal fees from Janssen-Cilag during the conduct of the study; personal fees from Janssen, Lundbeck, Otsuka, Casen-Recordati, Angelini, Adamed, Exeltis, Osakidetza and Ferrer, and grants from Instituto de Salud Carlos III, outside the submitted work.GS reports personal fees from Janssen-Cilag during the conduct of the study; personal fees from Janssen-Cilag, Lilly, Lundbeck, Astra Zeneca, VSM, and Eurogenics outside the submitted work.AV reports personal fees from Angelini, personal fees from Innovapharma, Pfizer and Recordati, grants from Boehringer Ingelheim and Takeda, grants and personal fees from Janssen-Cilag, Lundbeck and Otsuka outside the submitted work.