Protocol amendments
RECRUITMENT
The IgNiTE study was halted in October 2017 after the withdrawal of funding due to slower than anticipated recruitment. This was despite the proposal of alternative strategies to deliver on the study objectives, including revision of the recruitment timeline to ensure that the objectives of this important clinical study could be met. Where possible, follow-up activities were completed for all participants who were already enrolled into the trial, as per the protocol. The protocol was amended to remove endpoints which could not be derived from the data collected and to update the statistical analysis section.