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Evaluation by the same psychometric examiner before and after treatment, as required by the protocol, was not possible for 26 of the 113 patients (23.0%).
The MTD, as defined by the protocol, was not reached in the 20MI arm because no DLTs were observed.
Furthermore, RR to first- and second-line chemotherapy planned by the protocol was 82% (31 out of 38).
The NHS tariff cost of the regimen specified by the protocol was 7.9-times greater than the costs estimated from measured resource use, with corresponding implications for the ICER.
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The protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital.
The protocol was approved by the Rocky Mountain Laboratories Animal Care and Use Committee (protocol no. 2009-36).
The protocol was approved by the Seattle Children's Research Institutional Animal Care and Use Committee.
The protocol was approved by the Institutional Animal Care and Use Committee of the Biological Resource Centre, A*STAR (protocol #100520).
The protocol was approved by the Committee on the Ethics of Animal Experiments of the Nanjing Military General Hospital.
The protocol was approved by the National Institute of Allergy and Infectious Diseases (NIAID IRBB at the NIH.
The protocol was approved by RES Committee East of England Cambridge Central (WTSI protocol number 15/046).
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