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The event was considered unrelated to bosutinib treatment or to a clinical trial procedure by the investigator.
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However, routine clinical trial procedures can be difficult to apply in emergency public health crises hence require a consideration of alternative approaches on how therapies in these situations are tested and brought to the market.
Although we did not specifically ask as part of the clinical trial procedures if the participants were sex workers, most exchanged sex for money.
It was clear that some interventions assume that people are familiar with clinical trial procedures [ 9].
This would bring us closer to clinical trial procedures, leading to much more credible results.
The intervention reported in this paper used everyday examples in explaining clinical trial procedures and their implications.
Operationally, the implementation of a nested case control study in real time with the CAPRISA 004 trial was successful and resulted in minimal disruption of clinical trial procedures.
Potential trial participants can be assisted to understand key clinical trial procedures, their justification and personal implications by using innovative tailored local narratives.
Community Advisory Groups should also be educated on clinical trial procedures so that they can review the contents of the consent forms and materials [ 17].
The intervention which was tested through this study may guide future researchers in implementing more effective measures to maximise participants' understanding of essential clinical trial procedures.
Different from typical clinical trial procedures, there was no scheduled vertebral radiograph to capture potential asymptomatic new or worsened morphometric vertebral fractures.
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CEO of Professional Science Editing for Scientists @ prosciediting.com