A written informed consent form will be given to every participant before the clinical trial. This clinical trial will follow the requirements of Declaration of Helsinki, International Ethical ...

CIOMS VIII 1 defines a safety signal as “Information that arises from one or multiple sources (including observations and experiments), which suggests a new potentially causal association, or a new ...

The EUnetHTA HTA Core Model for Rapid Relative Effectiveness, V.4.2 published in 2015, states that both relative benefits and harmful effects of a technology are essential in quantifying the net ...