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Potential participants were informed by graduate clinic faculty and support staff of the overall requirements and procedures of the clinical study, the nature of the planned treatment, alternative procedures and the potential risks, possible complications and benefits of the proposed treatment.
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Fig. 1 Timeline of the clinical study.
DM, DC, DK and DŠ performed the clinical study procedures.
KMM, MRR, MLH and OATP performed the clinical study procedures.
In fact, in an in vitro study, published after the clinical procedures of the present study were concluded, it was shown that best adsorption of EMD on bone substitute particles is achieved when particles are dry and EMD is allowed to adsorb for at least 5 min.
The principal investigator also explains the overall goals and procedures of the study to all clinical staff at their regularly scheduled team meetings.
Fig. 1 Outline of clinical evaluations and study procedures of the RADAR study.
Prior to the study, all medical specialists in the clinic and attending therapists have been given a briefing on the study protocol, the ethical basis of this clinical study, the randomisation procedure, and the specific therapy for each treatment group, in line with the study protocol.
Understanding the impact of these factors on probiotic efficacy will aid in elucidating the molecular mechanisms of probiotic function, improve the design of probiotic-containing consumer products, and guide the establishment of standardized procedures for clinical studies intended to evaluate probiotic effects.
Registrars (and their practices and clinical supervisors) are educated extensively about the rationale for and procedures of the study.
Thus, during the last 35 years, several millions of cancer patients have received CDDP-based antineoplastic regimens, either as part of consolidated therapeutic procedures or in the context of clinical studies.
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