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If they were interested, eligibility was assessed and a full explanation of study involvement was provided.
This included a full explanation of study involvement, and a preliminary eligibility assessment by asking about the intended operation and assessing understanding of the information provided.
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All patients provided their written informed consent to participate in this study after a full explanation of the study had been given.
All controls and patients, and their parents, if participants were <20 years old, gave informed, written consent to participate in the study after receiving a full explanation of the study protocols and objectives.
On contacting the study team, participants were given a full explanation of the study via telephone and the opportunity to ask questions or take further time to consider participation if desired.
All participants gave informed consent after receiving a full explanation of the study design, objectives and explicit information regarding what the study entailed.
All participants gave informed consent after receiving a full explanation of the study design and objectives and explicit information regarding what the study entailed.
Institutional Review Board approval was obtained for each of the 48 study sites, and all participants gave written informed consent after receiving a full explanation of the study.
Every subject gave written informed consent after full explanation of the study aim and protocol.
Written consent to participate in the study was obtained from each patient (or the patient's guardian) after a full explanation of the study was provided.
Each participant was provided with a full explanation of the study and how to complete the questionnaire.
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