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Article History

Received: 2 December 2020

Accepted: 7 June 2023

First Online: 3 July 2023

Declarations

:

: Research ethics approval: The study is registered with the French National Agency for Medicines and Health Products Safety (No. 2020-A00158-31). Informed written consent to participate will be obtained from all participants.Protocol amendments: For the primary outcome, we changed the method of BP measurement from home BP monitoring to office BP measurement because home BP monitoring depends on participant involvement and ability. During the pilot study, too many participants failed to bring relevant home BP monitoring, a factor possibly rendering problematic the evaluation of our primary outcome. Office BP measurement is more relevant because it is conducted by health professionals at each follow-up appointment according to a specific and reproducible protocol.We initially wished to assess the adherence to lifestyle interventions, but later removed this aspect of the study because of the difficulties in collecting self-questionnaires during the pilot study and difficulties in obtaining relevant data considering the short period of the study.Protocol amendments began at the end of the pilot study conducted in 2022 and were completed in early 2023 subsequent to coordination with the institutional biomedical research unit.

: Not applicable

: Juliette Vay-Demouy (first author) reports, outside the submitted work, financial support from Boston Scientific SAS, Vitalaire, and AstraZeneca. Jacques Blacher reports, outside the submitted work, personal fees from Abbott, Bayer, Mylan Bottu, Ferring, Steripharma, Kantar, and Teriak and personal fees and non-financial support from Pfizer, Quantum Genomics, Sanofi, and Servier.Access to data: Access to the data will be granted on reasonable demand, for example, for meta-analyses.Ancillary and post-trial care: No ancillary is scheduled. Patients will return to their usual follow-up at the end of the study.Dissemination policy: Juliette Vay-Demouy will be the author of the article. Professionals who will participate in several steps of the protocol will review the manuscript and sign as co-authors.We plan to publish the results in peer-reviewed journals and communicate at conferences.