210 FUTURE RESEARCH of 8 days to complete the initial preliminary report. All other SAEs will be reported within a period of maximum 15 days after the investigator has first knowledge of the serious adverse events. Follow-up of adverse events All AEs will be followed until they have abated or until a stable situation has been reached. Depending on the event, follow up may require additional tests or medical procedures as indicated or referral to the general physician or a medical specialist. Follow-up is until 32 weeks because adverse events and complaints are expected mainly during the first month. SAEs need to be reported till the end of the study, as defined in the protocol. Statistical analysis Primary and secondary outcome analysis: Descriptive statistics will be used to assess outcomes Ethical considerations This study will be conducted according to the principles of the Declaration of Helsinki (64th WMA assembly 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other guidelines, regulations and Acts. This study will be conducted in accordance with the ‘gedragscode verzet van minderjarigen die deelnemen aan medisch-wetenschappelijk onderzoek’ published by the Dutch Society for Pediatricians in June 2001. Recruitment and consent After informed consent for the E-2DL by parents or caregivers, the clinician/first practitioner will ask the patient whether he or she wishes to receive information regarding the study and will, if this is the case, refer the patient to the study’s executive researcher. The researcher will in turn provide the patient with written (and verbal) information. In general waiting time for surgery in our center is 3 – 6
RkJQdWJsaXNoZXIy MjY0ODMw