Authors’ contributions {31b}
VLS and NKG are the principal investigators; VLS and NKG conceived the study and led the proposal and protocol development. VLS, NKG, DJA, DJH, MG, ES, and JH contributed to the study design and to the development of the proposal. All authors read and approved the final manuscript. Authorship for future publications will be decided by the principal investigators and will be in accordance with the International Committee of Medical Journal Editors guidelines.