Text and Data Mining valid from 2019-03-27
Received: 5 November 2018
Accepted: 18 March 2019
First Online: 27 March 2019
Compliance with ethical standards
: The authors declare that there are no competing interests regarding the publication of this paper.
: Ethical approval for the study was obtained via a consortium under the Nuclear Technologies in Medicine and Biosciences Initiative (NTeMBI) of South Africa and ethical approval by Pharma Ethics Pty, Ltd (Reference number 11064365). Pharma Ethics confirmed the following: “The study has been accepted as complying to the Ethics Standards for Clinical Research with a new drug in participants based on FDA, ICH GCP and the Declaration of Helsinki guidelines. The Ethics Committee (IRB) granting this APPROVAL is in compliance with the Guidelines for Good Practice in the Conduct of Clinical Trials in Human Participants in South Africa (2006), ICH Harmonised Tripartite Guidelines E6: Note: for the Guidance in Good Clinical Practice (CPMP/ICH/135/95) and FDA Code of Federal Regulation Part 50, 56 and 312.” Informed consent was obtained from all the participants in this study by means of a voluntarily completed consent form, included in the SI.
: All authors have given their approval of the version of the manuscript as submitted, their consent for publication and agreed to the accountability requirements.