Study design and oversight
The main goal of the TAMARIN study (EudraCT 2015-005497-38) was to obtain preliminary information on the safety and therapeutic activity of tamoxifen in MPN. TAMARIN is an investigator-driven A’herns design Phase II multicenter study approved by NHS Health Research Authority (IRAS 201126). The study was conducted in accordance with the Declaration of Helsinki and UK regulations (The Medicines for Human Use (Clinical Trials) Regulations 2004). The clinical trial authorization was provided by the Medicines and Healthcare products Regulatory Agency. The protocol was approved by the ethics committees of all involved institutions and is available with the full text of this article. The Clinical Study Protocol and the Statistical Analysis Plan, including the sample size calculations, interim safety analysis, analysis methods, Bayesian analysis, hematological response, and other exploratory outcomes are available in the Supp. Note. The authors designed the study, collected and analyzed the data, and wrote or edited the manuscript for submission.