Contributors
SD
IS was the principal investigator and JKB was responsible for study conceptualisation. JKB, IS, AS, LLE, RN, AWS, WB, SL, IE, JAG, J-PK, SD, EC, SJ, MT, and NG contributed to the study design and protocol development. SD and LKT were responsible for funding acquisition. LKT, SD, HS, AM, and EC were responsible for the project administration. IS, JKB, AS, KC, LLE, YWS, DS, AWS, WB, CBP, SL, EC, KF, AB, DF, SD, JAG, and LKT contributed to the implementation of the study or data collection. DS, AWS, RN, and CC-D were responsible for laboratory analyses. KR was responsible for statistical analysis. HS and AM led discussion related to the pharmacokinetic data analysis, absence of pharmacokinetic samples and effect on the manuscript, regulatory study activities, and reporting. II, MT, and NG were responsible for the pharmacokinetic data acquisition. HS and AM were responsible for the pharmacokinetic data management activities. JKB, IS, LLE, RN, AWS, LKT, J-PK, DF, SJ, EC, KR, NG, HS, AM, MT, and SD contributed to data interpretation. EC and LKT wrote the first draft of the manuscript and suggested the visual presentation of the data. LKT, JKB, and EC had full access to all the analysed data received to date and verified all data. All authors had access to the available analysed data, contributed to manuscript revision, take responsibility for the content of the manuscript, and had final responsibility for the decision to submit for publication.