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Ethical approval is not needed for this type of study in the Netherlands.
Ethics approval was not required for this type of study in Italy or Argentina.
Ethical approval is not required for this type of study in Switzerland.
The Ethical committee did agree that specific ethical approval is not required for this type of study in The Netherlands.
According to Dutch law, written informed consent was not necessary for this type of study in 1998.
The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1471-2393/10/59/prepub Thistudydy is funded by Zon-MW, the Dutch Organisation for Health Research and Development, grant (170992303) Trial registration: The protocol is registered in the clinical trial register number NTR1859 Ethical approval is not required for this type of study in The Netherlands.
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Formal consent is not required for this type of study.
For this type of study informed consent is not required.
For this type of study, no formal consent was required.
Informed consent was not required for this type of study.
For this type of study, formal consent was not required.
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