An Open0label, Single0dose Study to Evaluate the Safety, Tolerability
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Day 1 Etelcalcetide - IV Admin Follow up EOS Bolus Dose* Day 3 - 10 Day 30 0.035 mg/kg * IV bolus dose to be administered after haemodialysis during rinse back CONFIDENTIAL Product: Etelcalcetide Protocol Number: 20140336 Date: 18 February 2016 Page 7 of 64 Study Glossary Abbreviation or Term Definition/Explanation Term: Electronic Source Data source data captured initially into a permanent electronic record (eSource) used for the reconstruction and evaluation of a trial. end of study for individual defined as the last day that protocol-specified procedures are subject conducted for an individual subject end of treatment defined as the last assessment for the protocol specified treatment phase of the study for an individual subject end of study (primary defined as when the last subject is assessed or receives an completion) intervention for the purposes of final collection of data for the primary endpoint(s). end of study (end of trial) defined as when the last subject is assessed or receives an intervention for evaluation in the study; if the study includes multiple parts (eg, safety follow-up or survival assessment), the end of study would include these additional parts Source Data information from an original record or certified copy of the original record containing patient information for use in clinical research. The information may include, but is not limited to, clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies). (ICH Guideline