Authors’ contributions {31b}
AD
MS is responsible for trial management; he contributed to the design and development of the protocol as well as drafting of the manuscript. HPL is the study site leader and co-initiated the project; he contributed to the design and development of the protocol. SL contributed to the design and development of the protocol. KK is the principal investigator and contributed to the design and development of the protocol. AD is the lead trial statistician and contributed to the design and the development of the protocol. AES contributed to the design and development of the protocol. TK is the sponsor and co-initiated the project; he contributed to the design and development of the protocol. All authors read and approved the final manuscript.