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Throughout the conduct of clinical trials, side effects are closely monitored, and changes in the study design are introduced through protocol amendments as necessary.
Protocol amendments were approved by the IRB before implementation or submitted to the IRB for information, as required.
In regulatory practice, some adjustments to study protocols are mostly made known to regulatory agencies in the form of so-called protocol amendments.
This paper describes the study design, interventions and protocol amendments introduced to adapt to evolving scientific knowledge, international guidelines and availability of ARV treatment.
All protocol amendments will be disseminated to participating centres.
During the study, there were two major protocol amendments.
The protocol amendments to date are listed in table 1.
No protocol amendments were made during the study conduct.
Protocol amendments are often necessary in clinical trials.
Protocol amendments are listed in Additional file 1.
Methods— Protocol amendments The PI will submit protocol amendments to the UBC Clinical Ethics Board for approval.
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