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Table 2 Participant withdrawal criteria

From: A randomised controlled trial evaluating arrhythmia burden, risk of sudden cardiac death and stroke in patients with Fabry disease: the role of implantable loop recorders (RaILRoAD) compared with current standard practice

Withdrawal criteria

Participant’s withdrawal of consent

An adverse event (AE) or serious adverse event (SAE) requiring withdrawal from study (determined by CERC)

Death

Substantial protocol deviation

Investigator or sponsor decision

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Trials

ISSN: 1745-6215