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It is not necessarily sterile, and it is not injection-grade

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If temperatures fluctuated above 86 degrees for any portion of that time, degradation may be more significant than the time alone would suggest

2.6 Patients 2.6.1 Patient selection and study design Patients were enrolled in a prospective, investigator-initiated, non-randomized, multicenter, open-label study designed to evaluate in part A the safety and efficacy of DARA monotherapy in individuals with relapsed/refractory MM (RRMM) ( PB and BM samples from patients treated with DARA monotherapy in part A of the clinical study were collected at baseline, prior to initiation of DARA monotherapy, and at the time of DARA treatment failure (defined as disease progression [PD] during the first cycle of treatment, less than minimal response after the second treatment cycle, or less than partial response [PR] after the third treatment cycle), or in case of PD after an initial response (PR or better) for evaluation of adenosine (ADO) and inosine (INO) levels