 With a sample size of only 50 patients, this trial is not powered to detect differences in the incidence of common self-limited side effects and adverse reactions compared to standard therapy. For this reason, the trials limited power is augmented by a Trial Safety Committee TSC which is bound by rules that require suspension termination of trial accrual in the event of major complications See Section 8.3 of Data Monitoring - Human Ethics Application for Clinical Study or Part I: Section 5.3 on page 11 of the protocol. 