Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).

The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a > 30% decrease in iPTH compared with the initial values at baseline.

The percentage of participants with Calcium x Phosphorus Product (CxP) values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.

The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study.

The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.

Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.

The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.

The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.

Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).

Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.

An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.

The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug .