All patient-related information will be coded to secure patient protection. For trial analyses, validity-checked data will be transferred in the same way to the study statistician in HMC. The identifiable patient information will be password protected. The code identification list linking the subject’s identity should be maintained confidentially and stored separately in a sealed envelope and kept in a locked cabinet along with the study files with limited access. The team should ensure that screening, enrolment, and randomization details are recorded on a screening/enrolment and randomization log.
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