Temporary halt for reasons of subject safety
In accordance with section 10, subsection 4, of the Dutch law on medical scientific research “Wet medisch-wetenschappelijk onderzoek met mensen” (WMO), the sponsor will suspend the study if there is sufficient ground that continuation of the study will jeopardize the subject health or safety. The sponsor will notify the accredited METC without undue delay of a temporary halt including the reason for such an action. The study will be suspended pending a further positive decision by the accredited METC. The investigator will take care that all subjects are kept informed.