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. 2018 Aug 29;19:467. doi: 10.1186/s13063-018-2851-9

Table 2.

Amendments to date

List of amendments Summary of change
SA01
14/09/2016
• Personnel randomising to the trial has changed from pharmacy to research members as the randomisation software allows randomisation while protecting the blind
• Minor change to inclusion criteria – removed ‘modified RECIST’ from measurable disease section
SA02
25/01/2017
• Change to eligibility criteria – removed ‘measurable disease on CT (tumour thickness > 5 mm)’
• Dr. Steve Walker added as sub-investigator
• Radiological data collection is further explained in section 5.13
• Plan of analysis (Section 6.1) details how the radiological information will be used to calculate the sample size for the full study
SA03
26/04/2017
• Addition of Patient appointment schedule v1.0 22/03/17
SA04
08/09/2017
• Request to interview patients who decline participation in the trial
• Clarify number of patients for semi-structured interview (up to data saturation rather than the previously stated 10)
NSA01
20/09/2017
• Extend recruitment period by 1 month, to November 2017