All patients provided informed consent to report individual patient data.
The informed consent to report the individual patient data was obtained from all participants included in the study.
Written informed consent to report these cases was obtained from the families of the patients.
The Human Research Ethics Committee at Curtin University approved this study RDHS-08-14 RDHS-08-14 RDHS-08-14s provided informed consent, including consent to report de-identified pandicipall-level data.
If deemed necessary, the patient was asked to provide samples of the NHPs and drugs taken at the time of the AE(s) for laboratory analysis in phase II and for consent to report the AE(s) to Health Canada, if this had not already been done.
Eight patients were invited to participate and one of them did not consent to participate reporting having no time for this.
Obtaining consent not to report the particular finding has been acceptable solution.
Patients were not utilized in this study, therefore the authors have no consent information to report.
The majority of patients (187/200; 93.5%) consented to SFs reporting for one or more available categories (Table 2 ).
Overall, patients were significantly more likely to consent to SFs reporting than not (P < 0.0001).
