Table 5

Protocol amendments

Protocol updateProtocol versionProtocol dateReason for amendment
NAV11 January 2013NA
Substantial amendmentV11 January 2013Addition of new sites.
Substantial amendmentV2*
V3
1 December 2013
1 June 2014
See note below.
Replacement of the drug ibudilast with fluoxetine.
Substantial amendmentV425 May 2015Change to eligibility criteria to exclude patients on high-dose simvastatin. Clarification in patient information sheet about side effects of fluoxetine.
Substantial amendmentV51 November 2016Protocol updated to reflect changes to fluoxetine summary of product characteristics.
Non-substantial amendmentV65 October 2017To update new trials unit address and telephone numbers.
Substantial amendmentV65 October 2017To update change of PI.
Non-substantial amendmentV74 June 2018To correct typing error of ClinGov number.
  • *Protocol V.2 was submitted for the Clinical Trial Authorisation.

  • NA, not applicable.