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After obtaining informed their consent to participate, patients who had orthopnea [8] or who met the published criteria of Leigh et al. [16] were offered NIV in the hospital during admission, using a bilevel positive-pressure ventilator (BiPAP; Respironics, Vitalaire, Italy).
Due to the difficulty of ensuring that those who agree to take part in trials are both fully informed of, and understand, the risks and benefits of doing so, we are also conducting an audit of consent procedures to assess the motivation of clinical trial participants and to see how informed their consent really is.
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All participants were invited to participate of the study and signed a term informing their consent.
Patients were not informed nor their consent sought.
All patients included in the study, or their relatives, gave informed consent to their participation.
All subjects gave their informed written consent.
All participants gave their informed written consent prior to participation.
Participants gave their informed written consent to the experimental procedure.
All participants gave their informed written consent.
All patients gave their informed, written consent.
Patients gave their informed, written consent prior to study enrolment.
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