The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.

ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.

The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the positive percent agreement (PPA, analogous to sensitivity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.

PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.

The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.

ITD population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.

The majority blinded visual interpretation of each participant's image (3 blinded readers) was compared to his/her final clinical diagnosis, and the image interpretation was classified as true positive, false positive, true negative, or false negative. The counts of each classification type were used to determine the negative percent agreement (NPA, analogous to specificity) of the blinded visual image interpretations. The majority assessment was based on ≥ 2 of the 3 readers in agreement on the assessment.

PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.

Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.

The intent-to-diagnose (ITD) population that included all participants who underwent SPECT imaging after receiving DaTscan™ and enrolled in the study. Here, number of participants analyzed = participants with available data for this outcome measure.

Overall percent agreement (OPA) regardless of image interpretation (analogous to accuracy; ratio of number of true results / number of all participants) for each racial group, was tested to determine if it was greater than 80% in both racial groups. The majority assessment was based on ≥2 of the 3 readers in agreement on the assessment.

PP population consisted of all participants who met inclusion/exclusion criteria, had DaTscan™ image sets that were considered evaluable by ≥2 of the 3 blinded readers, and had no major protocol violations from any of the matched pair participants. Here, number of participants analyzed = participants with available data for this outcome measure.