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The patients were able to contact the involved neurologist at any time if there was any adverse event, side effect or allergic reaction.
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Safety will be evaluated by reporting adverse events; side effects and QoL using validated questionnaires.
Neither study reported adverse events, side effects or mortality attributable to testosterone administration.
The traveller may experience adverse events (side effects) leading to withdrawal, or may experience adverse events without withdrawal or may not experience adverse events from the malaria chemoprophylaxis.
All study participants will be issued a patient diary in which they can record any adverse events, side effects, injection site reactions and angina burden.
For example, the desired utility of a QOL questionnaire in a drug trial may be to identify the prevalence of adverse events (side effects) and detect differences between treatment arms.
Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy.
There is no expected adverse event or side effect for participants.
Moreover, information on any adverse event, including side effects of study treatments, will be collected during the treatment period (visits 2 – 11).
The investigation will cease when (1) discontinuation of the study is recommended by the data safety monitoring board due to an adverse event or side effect that makes continuation of the investigation difficult or (2) the principal investigator decides not to continue implementation.
The use of a fast-resorbable antibiotic-loaded hydrogel implant coating provides a reduced rate of post-surgical site infections after internal osteosynthesis for closed fractures, without any detectable adverse event or side-effects.
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