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KST wrote the ethics submission and supervised recruitment of patients.
EK co-authored the protocol and contributed to the ethics submission.
MK and LJ obtained funding for development of the study protocol and ethics submission.
SLW is responsible for compiling this manuscript, ethics submission, and is involved with recruitment and retention.
TC drafted the manuscript, co-authored the protocol and contributed to the ethics submission.
PC conceived of the study, co-authored the protocol and contributed to the ethics submission.
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Ethics: Submissions should acknowledge all collaborators and sources consulted.
Ethics submissions never go seamlessly.
The study startup phase is where this happens, and it includes such activities as site and investigator selection, regulatory and ethics submissions and ends with the site initiation visits and release of the investigational product (i.e., the drug under investigation).
The Trial Coordinating Centre Team assists Units joining the study with ethics submissions and organisational matters.
Clinical trial support group members support protocol development, assist with ethics submissions, provide project and data management support, deliver training and assist in the quality management of trials.
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