Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease

The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis.

Time frame: Week 0 and FAP (up to Week 24)

Population: Per Protocol Set (PPS): participants with exclusion from the Full Analysis Set (FAS) of those violating the study protocol and assessed to be excluded from the assessment of drug efficacy. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug.

Time frame: Weeks 0 and 54

Population: Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.

The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.

The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.

The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.

The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 0.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at Week 54 minus Off time (hours) at Week 0.

Time frame: Weeks 0 and 54

Population: Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

On state is defined as the state at which PD symptoms are well controlled by the drug. Mean Change from Week 0 in On time (actual hours) was calculated as On time (hours) at FAP minus On time (hours) at Week 0. Participants who had only one observation for On time were not included in the analysis.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at Week 54 minus On time with troublesome dyskinesias (hours) at Week 0.

Time frame: Weeks 0 and 54

Population: Long-FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time \[hours\]/Sum of two days awake time \[hours\]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 0.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time \[hours\]/Sum of two days awake time \[hours\]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at Week 54 minus Off time (proportion) at Week 0.

Time frame: Weeks 0 and 54

Population: Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

On state is defined as the state at which PD symptoms are well controlled by the drug. On time is measured as a proportion using the following formula: (Sum of two days On time \[hours\]/Sum of two days awake time \[hours\]) x 100. Change from Week 0 in On time is measured using the following formula: On time (proportion) at FAP minus On time (proportion) at Week 0. Participants who had only one observation for On time were not included in the analysis.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as On time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

On time with troublesome dyskinesias is measured as a proportion using the following formula: (Sum of two days On time with troublesome dyskinesias \[hours\]/Sum of two days awake time \[hours\]) x 100. Change from Week 0 in On time with troublesome dyskinesias is measured using the following formula: On time with troublesome dyskinesias (proportion) at FAP minus On time with troublesome dyskinesias (proportion) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as On time with troublesome dyskinesias at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Particpants with only one observation for the part II (at Off) total score were not included in the analysis.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Only participants who had Off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.

Time frame: Weeks 0 and 54

Population: Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the score at Week 0.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part II (at On) total score were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part I total score were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one observation for the part IV total score were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 24 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.

On state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 24 on On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 24. Participants who had 0 hour as On time with troublesome dyskinesias at Week 24 were excluded from the analysis.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were also not included in the analysis.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time \[hours\]/Sum of two days awake time \[hours\]) x 100. Change from Week 24 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. Participants who had 0 hour as Off time at Week 24 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. Off state is where PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.

The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. On state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.

The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS: participants who were included in the FAS and progressed to the PR/XR Switching Phase. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Off time is measured as a proportion using the following formula: (Sum of two days off time \[hours\]/Sum of two days awake time \[hours\]) x 100. Percent change from Week 0 in Off time (proportion) is measured using the following formula: (Change from Week 0 in Off time \[proportion\]/Off time \[proportion\] at Week 0) x 100.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. Only participants who had off state were included in the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.

The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had off state were included in the analysis.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.

The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. Off state is defined as the state at which PD symptoms are not adequately controlled by the drug.

Time frame: Weeks 0 and 54

Population: Long-FAS. Only participants who had off state were included in the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.

The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug.

Time frame: Week 0 and FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis for the FAP.

The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug.

Time frame: Week 24 and FAP (from Week 26 up to Week 32)

Population: Switching-FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include Week 24 values. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis for the FAP.

The Modified Hoehn & Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. On state is defined as the state at which PD symptoms are well controlled by the drug.

Time frame: Weeks 0 and 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis for Week 54.

The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 54) was the event, and participants who had completed the study were censored.

Time frame: 0-385 days (up to Week 54)

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected.

The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.

Time frame: 0-175 days (up to Week 24)

Population: FAS. Data were evaluated only at the time point at which they had been collected.

The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.

Time frame: 0-175 days (up to Week 24)

Population: FAS. Data were evaluated only at the time point at which they had been collected.

The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.

Time frame: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)

Population: Switching-FAS. Data were evaluated only at the time point at which they had been collected.

The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.

Time frame: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)

Population: Switching-FAS. Data were evaluated only at the time point at which they had been collected.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on change from Week 0 in Off time (percentage).

Time frame: FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in change from Week 0 in Off time (percentage).

Time frame: Week 54

Population: Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in percent change from Week 0 in Off time (percentage).

Time frame: FAP (up to Week 24)

Population: FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

Off state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on percent change from Week 0 in Off time (percentage).

Time frame: Week 54

Population: Long-FAS. Participants who had 0 hour as Off time at Week 0 were excluded from the analysis. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

The CGI-I assesses the participant's improvement or worsening of PD from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.

Time frame: Week 54

Population: Long-FAS. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.

The CGI-I assesses the participant's improvement or worsening of PD from Baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.

Time frame: FAP (up to Week 24)

Population: FAS. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 were not included in the analysis.

Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one measurement for the part III total score were not included in the analysis.

Time frame: FAP (up to Week 24)

Population: FAS: participants who were progressed to the Non-Inferiority Verification Phase but excluding those who did not have the target indication, those who had not received at least one dose of investigational product, and those whose measured data in efficacy were not available after treatment initiation.

Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 (Baseline) in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score.

Time frame: Week 54

Population: Long-FAS: participants who were included in the FAS and entered into the Long-term Phase. Data were evaluated only at the time point at which they had been collected; participants whose observation could not be obtained because of their premature withdrawal or other reasons were not included in the analysis.