A board certified neurosurgeon confirmed the results of registration before commencement of the tumor image extraction process.
The registration announcement marked the commencement of the vaccination program for Australian adults.
Although registration of the trial occurred after commencement of the study (Australian New Zealand Clinical Trial Registry, ACTRN12610000713099), no changes were made to the study design or protocol in the time prior to and time after registration.
Patient history, baseline signs and symptoms, full blood count and chemistry (alkaline phosphatase, AST, ALT, total and direct bilirubin, electrolytes and creatinine) were performed within the 8 days prior to registration and thereafter prior to the commencement of each cycle.
This study has received ethical approval from the University of South Australia Human Research Ethics Committee prior to study commencement and is registered with the Australian New Zealand Clinical Trials Registry (Trial Registration: ACTRN12613000473763).
Prior to the commencement of data collection, the researcher met with the manager of the local Registration and Inspection Unit (an independent organisation responsible for regulating nursing homes) who provided a list of all the nursing homes in the study site (n = 20).
Participants who (i) discontinue the online registration process; (ii) report obtaining an influenza vaccination in 2010 before the commencement of the study; or (iii) report being influenced by other participants to undertake influenza vaccination will be excluded from analysis.
The study was conducted, recorded and reported in accordance with the Helsinki Declaration of 1975, as revised in 2000 and 2008 and prior to the commencement, the ethics committee of the Clinical San Carlos Hospital, Madrid, Spain, approved the protocol and informed consent forms under the registration number 13/404-P.
Rain on Commencement Day?
Commencement is scheduled for Wednesday.
