| Outcome Measures: |
Primary: Number of Subjects With Treatment Emergent Adverse Events (TEAEs) and Number of Subjects Who Discontinued Study Drug Due to a TEAE, The number and percentage of subjects who reported treatment-emergent adverse events (TEAEs) summarized by system organ class and preferred term (see Reported Adverse Events) as well as by severity, causality, seriousness, and action taken with regard to study drug. All analyses were descriptive., Through treatment period completion (Day 15)|Change From Baseline to the End of Treatment (Day 15) in Serum Bicarbonate Within Each Individual TRC101 Dose Group, Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline, Baseline and Day 15 | Secondary: Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between Each TRC101 Dose Group Versus Placebo, Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for each TRC101 dose group versus that for Placebo, Baseline and Day 15|Change From Baseline in Serum Bicarbonate at Day 15 Within the Combined TRC101 Treatment Group, Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline, Baseline and Day 15|Comparison of Change From Baseline in Serum Bicarbonate at Day 15 Between the Combined TRC101 Treatment Group Versus Placebo, Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the Combined TRC101 Treatment Group versus that for Placebo, Baseline and Day 15|Comparison of the Proportion of Subjects Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Between Each TRC101 Dose Group Versus Placebo, Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between each TRC101 BID Dose Group versus Placebo, Baseline and Day 15|Change From Baseline in Serum Bicarbonate at Day 15 Within the TRC101 6g QD Dose Group, Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline, Baseline and Day 15|Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus Placebo, Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g dose group versus that for Placebo, Baseline and Day 15|Change From Baseline in Serum Bicarbonate at Day 15 Comparison Between the TRC101 6g QD Dose Group Versus the TRC101 3g BID Dose Group, Serum bicarbonate at Day 15 minus serum bicarbonate at Baseline for the TRC101 6g QD dose group versus that for the TRC101 3g BID dose group, Baseline and Day 15|Comparison of the Proportion of Subjects in the TRC101 6g QD Dose Group Whose Serum Bicarbonate Values Increased From Baseline to Day 15 by Greater Than or Equal to 2, 3, or 4 mEq/L Versus Placebo, Comparison of the proportion of subjects whose serum bicarbonate values increased from Baseline to Day 15 by greater than or equal to 2, 3, or 4 mEq/L between the 6g TRC101 QD Dose Group versus Placebo, Baseline and Day 15
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| Locations: |
Investigative Site 1, Sofia, Bulgaria|Investigative Site 3, Tbilisi, Georgia|Investigative Site 4, Tbilisi, Georgia|Investigative Site 5, Tbilisi, Georgia|Investigative Site 6, Tbilisi, Georgia
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