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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Cohort 1 to 3 = up to 120 Weeks and Cohort 4 = up to 88 Weeks
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Maximum Plasma Concentration (Cmax)
Time frame: Week 2 and 12
The Cmax is the maximum plasma concentration.
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Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: Week 2 and 12
The Tmax is time to reach the maximum plasma concentration.
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Minimum Plasma Concentration (Cmin)
Time frame: Week 2, 12 and 24
The Cmin is the minimum plasma concentration.
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Area Under the Plasma Concentration-time Curve From the Time of Dose Administration up to X Hours (AUCtime-h)
Time frame: Week 2, 12 and 24
AUCtime-h is the area under the plasma concentration-time curve from the time of dose administration up to X hours.
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Elimination Half-life (t1/2)
Time frame: For Cohorts 1 to 3: Day 1, Weeks 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120; For Cohort 4: Day 1, Weeks 2,12, 24, 32, 48, 88
Elimination half-life (t [1/2]) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z). Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
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Area Under the Plasma Concentration-time Curve From the Time of Dose Administration up to 168 Hours [AUC168h]
Time frame: Week 12 and 24
AUC168h is the area under the plasma concentration-time curve from the time of dose administration up to 168 Hours.
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Volume of Distribution (Vd)
Time frame: For Cohorts 1 to 3: Day 1, Weeks 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120; For Cohort 4: Day 1, Weeks 2,12, 24, 32, 48, 88
Volume of distribution is calculated as Dose divided by Lambda(z) multiplied by AUC(infinity). The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time.
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Apparent Clearance (CL)
Time frame: For Cohorts 1 to 3: Day 1, Weeks 2, 4,6,8,12,16,20,24,28,32,40,48,60,72,84,96,108,120; For Cohort 4: Day 1, Weeks 2,12, 24, 32, 48, 88
Apparent clearance is calculated as Dose/AUC (infinity). The AUC (infinity) is the area under the plasma concentration-time curve from time zero to infinite time.