Trial Outcomes & Findings for Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease (NCT NCT00823836)

NCT ID: NCT00823836

Last Updated: 2017-01-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 302 participants
• Primary outcome timeframe: Week 0 and FAP (up to Week 24)
• Results posted on: 2017-01-18

Participant Flow

A total of 157 participants who were enrolled in the Non-Inferiority Verification (NV) Phase entered into the Long-term Phase after completing the Prolonged Release/Extended Release (PR/XR) Switching Phase according to the study design. The remaining participants entered into the Down-titration Phase after completing the PR/XR Switching Phase.

Participant milestones

Measure	Ropinirole PR-Ropinirole PR Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
NV and PR/XR Switching Phases STARTED	156	146
NV and PR/XR Switching Phases COMPLETED	124	117
NV and PR/XR Switching Phases NOT COMPLETED	32	29
Long-term Phase STARTED	73	84
Long-term Phase COMPLETED	68	79
Long-term Phase NOT COMPLETED	5	5

Reasons for withdrawal

Measure	Ropinirole PR-Ropinirole PR Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
NV and PR/XR Switching Phases Adverse Event	22	21
NV and PR/XR Switching Phases Protocol Violation	1	1
NV and PR/XR Switching Phases Physician Decision	5	2
NV and PR/XR Switching Phases Withdrawal by Subject	4	5
Long-term Phase Adverse Event	3	2
Long-term Phase Physician Decision	1	2
Long-term Phase Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ropinirole PR-Ropinirole PR n=156 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=146 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Total n=302 Participants Total of all reporting groups
Age, Continuous	69.3 Years STANDARD_DEVIATION 7.95 • n=5 Participants	68.3 Years STANDARD_DEVIATION 8.22 • n=7 Participants	68.8 Years STANDARD_DEVIATION 8.08 • n=5 Participants
Gender Female	93 Participants n=5 Participants	81 Participants n=7 Participants	174 Participants n=5 Participants
Gender Male	63 Participants n=5 Participants	65 Participants n=7 Participants	128 Participants n=5 Participants
Race/Ethnicity, Customized	156 participants n=5 Participants	146 participants n=7 Participants	302 participants n=5 Participants

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=141 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=133 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase	-10.8 scores on a scale Standard Deviation 8.32	-11.0 scores on a scale Standard Deviation 7.56

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=151 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=139 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase 30 percent responder	66 percentage of participants	69 percentage of participants
Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase 20 percent responder	81 percentage of participants	78 percentage of participants

SECONDARY outcome

Timeframe: 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 FAP minus the total score at Week 0.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=151 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=142 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase	-0.2 scores on a scale Standard Deviation 1.25	-0.3 scores on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: 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 FAP minus the score at Week 0.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=151 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=142 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase	-2.6 scores on a scale Standard Deviation 3.69	-2.9 scores on a scale Standard Deviation 4.17

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=66 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=74 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 24 in the Non-Inferiority Verification Phase	-4.7 scores on a scale Standard Deviation 4.49	-3.8 scores on a scale Standard Deviation 5.15

SECONDARY outcome

Timeframe: 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 FAP minus the total score at Week 0.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=151 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=141 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase	-0.6 scores on a scale Standard Deviation 1.51	-0.2 scores on a scale Standard Deviation 1.68

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=156 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=146 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase Week 0; n=156, 146	0.9 scores on a scale Standard Deviation 1.30	1.1 scores on a scale Standard Deviation 1.35
Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase FAP; n=151, 142	0.7 scores on a scale Standard Deviation 1.34	0.8 scores on a scale Standard Deviation 1.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=156 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=146 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part II (at "On") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase Week 0; n=156, 146	7.7 scores on a scale Standard Deviation 5.51	7.6 scores on a scale Standard Deviation 5.87
Japanese UPDRS Part II (at "On") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase FAP; n=151, 142	5.2 scores on a scale Standard Deviation 5.21	4.6 scores on a scale Standard Deviation 5.23

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=86 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=88 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part II (at "Off") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase Week 0; n=86, 88	13.6 scores on a scale Standard Deviation 8.03	13.1 scores on a scale Standard Deviation 6.64
Japanese UPDRS Part II (at "Off") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase FAP; n=66, 76	9.6 scores on a scale Standard Deviation 7.24	8.7 scores on a scale Standard Deviation 6.39

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=156 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=146 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase Week 0; n=156, 146	24.0 scores on a scale Standard Deviation 9.47	24.3 scores on a scale Standard Deviation 9.81
Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase FAP; n=151, 139	13.7 scores on a scale Standard Deviation 9.91	12.7 scores on a scale Standard Deviation 9.39

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=156 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=146 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase Week 0; n=156, 146	2.7 scores on a scale Standard Deviation 2.59	2.8 scores on a scale Standard Deviation 2.54
Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase FAP; n=151, 141	2.1 scores on a scale Standard Deviation 2.25	2.6 scores on a scale Standard Deviation 2.49

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=151 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=142 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase	63 percentage of participants	61 percentage of participants

SECONDARY outcome

Timeframe: 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 change from Week 0 in Off time (percentage).

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=78 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=77 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Responders in Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase	44 percentage of participants	40 percentage of participants

SECONDARY outcome

Timeframe: 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 percent change from Week 0 in Off time (percentage).

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=78 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=77 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Responders in Percent Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase	76 percentage of participants	69 percentage of participants

SECONDARY outcome

Timeframe: 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 FAP minus Off time (hours) at Week 0.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=78 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=77 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase	-2.88 hours Standard Deviation 3.941	-2.59 hours Standard Deviation 4.691

SECONDARY outcome

Timeframe: 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 FAP minus Off time (proportion) at Week 0.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=78 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=77 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase	-18.39 percentage of time Standard Deviation 23.600	-16.81 percentage of time Standard Deviation 27.150

SECONDARY outcome

Timeframe: 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. 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=78 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=77 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Percent Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase	-42.36 percent change Standard Deviation 77.250	-40.48 percent change Standard Deviation 60.344

SECONDARY outcome

Timeframe: 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. 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=149 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=134 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase	1.65 hours Standard Deviation 3.215	1.35 hours Standard Deviation 3.539

SECONDARY outcome

Timeframe: 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. "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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=149 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=134 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Percentage of Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase	9.03 percentage of time Standard Deviation 18.634	7.79 percentage of time Standard Deviation 19.895

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=7 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=13 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase	0.57 hours Standard Deviation 3.886	0.87 hours Standard Deviation 2.311

SECONDARY outcome

Timeframe: 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" 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=2 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=13 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Percentage of Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase	2.61 percentage of time Standard Deviation 24.247	5.39 percentage of time Standard Deviation 14.399

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=156 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=146 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 3; n=151, 142	34 participants	27 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 0; n=156, 146	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 1; n=156, 146	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 1.5; n=156, 146	0 participants	1 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 2; n=156, 146	34 participants	34 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 2.5; n=156, 146	47 participants	43 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 3; n=156, 146	64 participants	57 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 4; n=156, 146	11 participants	10 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 5; n=156, 146	0 participants	1 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 0; n=151, 142	2 participants	4 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 1; n=151, 142	20 participants	18 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 1.5; n=151, 142	3 participants	14 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 2; n=151, 142	54 participants	44 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 2.5; n=151, 142	31 participants	29 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 4; n=151, 142	7 participants	6 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 5; n=151, 142	9 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=86 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=88 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 0; n=86, 88	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 1; n=86, 88	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 1.5; n=86, 88	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 2; n=86, 88	4 participants	7 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 2.5; n=86, 88	13 participants	14 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 3; n=86, 88	39 participants	37 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 4; n=86, 88	24 participants	26 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase Week 0; Stage 5; n=86, 88	6 participants	4 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 0; n=66, 76	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 1; n=66, 76	5 participants	2 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 1.5; n=66, 76	3 participants	1 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 2; n=66, 76	9 participants	23 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 2.5; n=66, 76	13 participants	11 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 3; n=66, 76	19 participants	22 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 4; n=66, 76	15 participants	14 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase FAP; Stage 5; n=66, 76	2 participants	3 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=156 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 0 days	100 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 6 days	99 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 9 days	99 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 14 days	98 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 17 days	97 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 19 days	96 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 20 days	96 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 21 days	93 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 25 days	92 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 28 days	91 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 34 days	90 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 42 days	90 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 43 days	89 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 55 days	88 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 62 days	88 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 74 days	87 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 119 days	86 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 139 days	85 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 142 days	85 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 153 days	84 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 154 days	83 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 160 days	83 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 168 days	82 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group 175 days	82 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=146 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 0 days	100 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 7 days	99 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 12 days	99 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 14 days	97 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 18 days	97 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 21 days	96 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 28 days	94 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 30 days	93 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 32 days	92 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 42 days	90 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 51 days	90 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 55 days	88 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 60 days	88 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 86 days	87 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 88 days	86 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 119 days	86 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 142 days	85 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 168 days	84 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group 175 days	84 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=127 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=120 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase	-0.0 scores on a scale Standard Deviation 0.40	0.1 scores on a scale Standard Deviation 0.45

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=126 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=119 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 24 in the Japanese UPDRS Part II (at "On") Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase	-0.0 scores on a scale Standard Deviation 1.37	0.3 scores on a scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: 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. "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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=57 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=60 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 24 in the Japanese UPDRS Part II (at "Off") Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase	-0.2 scores on a scale Standard Deviation 1.89	-0.4 scores on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=125 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=117 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase	-0.2 scores on a scale Standard Deviation 2.81	-0.7 scores on a scale Standard Deviation 3.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=127 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=119 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase	-0.1 scores on a scale Standard Deviation 0.64	-0.2 scores on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=127 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=122 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; n=127, 122	0.5 scores on a scale Standard Deviation 0.96	0.6 scores on a scale Standard Deviation 1.22
Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; n=127, 120	0.4 scores on a scale Standard Deviation 1.04	0.7 scores on a scale Standard Deviation 1.34

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=127 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=122 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part II (at "On") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; n=127, 122	4.4 scores on a scale Standard Deviation 4.59	4.1 scores on a scale Standard Deviation 4.60
Japanese UPDRS Part II (at "On") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; n=126, 119	4.4 scores on a scale Standard Deviation 4.59	4.3 scores on a scale Standard Deviation 4.88

SECONDARY outcome

Timeframe: 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. Only participants who had "off" state were included in the analysis.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=58 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=63 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part II (at "Off") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; n=58, 63	8.8 scores on a scale Standard Deviation 6.80	7.8 scores on a scale Standard Deviation 5.57
Japanese UPDRS Part II (at "Off") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; n=57, 61	8.5 scores on a scale Standard Deviation 7.31	7.5 scores on a scale Standard Deviation 5.78

SECONDARY outcome

Timeframe: 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. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=127 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=121 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; n=127, 121	11.9 scores on a scale Standard Deviation 8.63	12.3 scores on a scale Standard Deviation 8.91
Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; n=125, 118	11.7 scores on a scale Standard Deviation 8.23	11.3 scores on a scale Standard Deviation 8.86

SECONDARY outcome

Timeframe: 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. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=127 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=121 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; n=127, 121	1.9 scores on a scale Standard Deviation 2.14	2.5 scores on a scale Standard Deviation 2.47
Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; n=127, 119	1.9 scores on a scale Standard Deviation 2.17	2.3 scores on a scale Standard Deviation 2.32

SECONDARY outcome

Timeframe: 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.

"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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=51 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=52 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 24 in Awake Time Spent "Off" at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase	-0.07 hours Standard Deviation 2.912	-0.13 hours Standard Deviation 2.005

SECONDARY outcome

Timeframe: 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.

"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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=51 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=52 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 24 in Percentage of Awake Time Spent "Off" at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase	-0.97 percentage of time Standard Deviation 16.470	-0.14 percentage of time Standard Deviation 12.913

SECONDARY outcome

Timeframe: 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.

"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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=9 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=12 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 24 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase	0.00 hours Standard Deviation 3.180	-1.25 hours Standard Deviation 1.831

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=127 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=122 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 0; n=127, 122	2 participants	4 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 1; n=127, 122	20 participants	16 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 1.5; n=127, 122	3 participants	12 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 2; n=127, 122	49 participants	41 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 2.5; n=127,122	25 participants	24 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 3; n=127, 122	22 participants	23 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 4; n=127, 122	6 participants	2 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 5; n=127, 122	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 0; n=125, 119	3 participants	3 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 1; n=125, 119	17 participants	19 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 1.5; n=125, 119	5 participants	10 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 2; n=125, 119	51 participants	44 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 2.5; n=125, 119	23 participants	20 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 3; n=125, 119	20 participants	20 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 4; n=125, 119	6 participants	2 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 5; n=125, 119	0 participants	1 participants

SECONDARY outcome

Timeframe: 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. Only participants who had "off" state were included in the analysis.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=58 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=63 Participants Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 2; n=56, 61	12 participants	16 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 0; n=58, 63	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 1; n=58, 63	5 participants	2 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 1.5; n=58, 63	3 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 2; n=58, 63	9 participants	21 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 2.5; n=58, 63	13 participants	11 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 3; n=58, 63	14 participants	18 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 4; n=58, 63	13 participants	9 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase Week 24; Stage 5; n=58, 63	1 participants	2 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 0; n=56, 61	0 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 1; n=56, 61	4 participants	3 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 1.5; n=56, 61	3 participants	0 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 2.5; n=56, 61	13 participants	15 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 3; n=56, 61	11 participants	18 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 4; n=56, 61	11 participants	7 participants
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase FAP; Stage 5; n=56, 61	2 participants	2 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=127 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group 0 days	100 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group 28 days	99 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group 35 days	98 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group 89 days	98 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=122 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group 0 days	100 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group 4 days	99 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group 7 days	98 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group 18 days	98 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group 28 days	97 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group 33 days	96 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group 89 days	96 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=68 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 30 percent responders	84 percentage of participants	—
Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 20 percent responders	76 percentage of participants	—

SECONDARY outcome

Timeframe: 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 Week 54 minus the total score at Week 0.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=68 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	-0.4 scores on a scale Standard Deviation 0.95	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=67 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	-2.6 scores on a scale Standard Deviation 4.23	—

SECONDARY outcome

Timeframe: 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. "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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=32 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	-4.6 scores on a scale Standard Deviation 3.83	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=68 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	-12.7 scores on a scale Standard Deviation 8.23	—

SECONDARY outcome

Timeframe: 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 Week 54 minus the total score at Week 0.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=68 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	-0.8 scores on a scale Standard Deviation 1.52	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=73 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0, n=73	1.1 scores on a scale Standard Deviation 1.34	—
Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54, n=68	0.6 scores on a scale Standard Deviation 0.93	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=73 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part II (at "On") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0, n=73	6.9 scores on a scale Standard Deviation 4.57	—
Japanese UPDRS Part II (at "On") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54, n=67	4.3 scores on a scale Standard Deviation 4.38	—

SECONDARY outcome

Timeframe: 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. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=44 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part II (at "Off") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0, n=44	13.2 scores on a scale Standard Deviation 7.40	—
Japanese UPDRS Part II (at "Off") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54, n=32	9.0 scores on a scale Standard Deviation 6.74	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=73 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0, n=73	24.6 scores on a scale Standard Deviation 8.54	—
Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54, n=68	11.9 scores on a scale Standard Deviation 8.08	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=73 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0, n=73	2.9 scores on a scale Standard Deviation 2.69	—
Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54, n=68	2.1 scores on a scale Standard Deviation 2.28	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=68 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Responders on the CGI-I at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	65 percentage of participants	—

SECONDARY outcome

Timeframe: 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 change from Week 0 in Off time (percentage).

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=39 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Responders in Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	46 percentage of participants	—

SECONDARY outcome

Timeframe: 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 on percent change from Week 0 in Off time (percentage).

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=39 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Responders in Percent Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase	79 percentage of participants	—

SECONDARY outcome

Timeframe: 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.

"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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=39 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	-2.87 hours Standard Deviation 3.642	—

SECONDARY outcome

Timeframe: 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.

"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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=39 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Percentage of Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	-18.55 percentage of time Standard Deviation 23.038	—

SECONDARY outcome

Timeframe: 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.

"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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=3 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Mean Change From Week 0 in Awake Time Spent "On" With Troublesome Dyskinesias at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group	-0.33 hours Standard Deviation 0.629	—

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=73 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 0; n=73	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 1; n=73	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 1.5; n=73	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 2; n=73	18 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 2.5; n=73	19 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 3; n=73	35 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 4; n=73	1 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 5; n=73	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 0; n=67	1 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 1; n=67	8 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 1.5; n=67	3 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 2; n=67	29 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 2.5; n=67	15 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 3; n=67	11 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 4; n=67	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 5; n=67	0 participants	—

SECONDARY outcome

Timeframe: 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. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=44 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 0; n=44	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 1; n=44	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 1.5; n=44	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 2; n=44	2 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 2.5; n=44	8 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 3; n=44	21 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 4; n=44	11 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 0; Stage 5; n=44	2 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 0; n=32	0 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 1; n=32	3 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 1.5; n=32	1 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 2; n=32	5 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 2.5; n=32	9 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 3; n=32	6 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 4; n=32	7 participants	—
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group Week 54; Stage 5; n=32	1 participants	—

SECONDARY outcome

Timeframe: 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 54) was the event, and participants who had completed the study were censored.

Outcome measures

Measure	Ropinirole PR-Ropinirole PR n=73 Participants Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 0 days	100 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 258 days	99 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 261 days	97 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 322 days	96 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 329 days	95 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 346 days	93 percentage of participants	—
Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group 385 days	93 percentage of participants	—

Adverse Events

Ropinirole PR-Ropinirole PR

Serious events: 16 serious events

Other events: 95 other events

Deaths: 0 deaths

Ropinirole IR-Ropinirole PR

Serious events: 16 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ropinirole PR-Ropinirole PR n=156 participants at risk Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=146 participants at risk Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Nervous system disorders Cerebral infarction	1.3% 2/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Nervous system disorders Dizziness	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Nervous system disorders Neuroleptic malignant syndrome	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Nervous system disorders Parkinson's disease	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Nervous system disorders Post herpetic neuralgia	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Infections and infestations Pneumonia	1.3% 2/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Infections and infestations Appendicitis	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Infections and infestations Cellulitis	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Infections and infestations Pyelonephritis	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Gastrointestinal disorders Colitis ischaemic	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Gastrointestinal disorders Diarrhoea	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Gastrointestinal disorders Enterocolitis	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Gastrointestinal disorders Haemorrhoids	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Injury, poisoning and procedural complications Compression fracture	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	1.4% 2/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Injury, poisoning and procedural complications Hip fracture	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Injury, poisoning and procedural complications Radius fracture	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Cardiac disorders Acute myocardial infarction	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Cardiac disorders Angina pectoris	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Cardiac disorders Atrial fibrillation	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Metabolism and nutrition disorders Decreased appetite	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Metabolism and nutrition disorders Dehydration	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Metabolism and nutrition disorders Hypoglycaemia	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Investigations Blood creatine phosphokinase increased	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Investigations Blood pressure orthostatic decreased	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Psychiatric disorders Agitation	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Psychiatric disorders Delusion	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Vascular disorders Arteriosclerosis obliterans	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Vascular disorders Orthostatic hypotension	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Eye disorders Macular degeneration	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
General disorders Fatigue	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Musculoskeletal and connective tissue disorders Myalgia	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Renal and urinary disorders Renal failure chronic	0.64% 1/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.00% 0/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	0.68% 1/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group

Other adverse events

Measure	Ropinirole PR-Ropinirole PR n=156 participants at risk Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.	Ropinirole IR-Ropinirole PR n=146 participants at risk Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
Nervous system disorders Somnolence	11.5% 18/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	11.6% 17/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Nervous system disorders Dyskinesia	5.8% 9/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	11.6% 17/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Nervous system disorders Dizziness	1.9% 3/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	8.2% 12/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Gastrointestinal disorders Nausea	12.8% 20/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	11.6% 17/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Gastrointestinal disorders Constipation	9.0% 14/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	7.5% 11/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Gastrointestinal disorders Vomiting	5.8% 9/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	3.4% 5/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Infections and infestations Nasopharyngitis	19.2% 30/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	19.9% 29/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Psychiatric disorders Hallucination	9.0% 14/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	6.2% 9/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Psychiatric disorders Insomnia	2.6% 4/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	5.5% 8/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Injury, poisoning and procedural complications Contusion	5.8% 9/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	4.8% 7/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Injury, poisoning and procedural complications Fall	5.8% 9/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	4.1% 6/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Vascular disorders Orthostatic hypotension	6.4% 10/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	7.5% 11/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Metabolism and nutrition disorders Decreased appetite	7.1% 11/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	4.8% 7/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group
Musculoskeletal and connective tissue disorders Back pain	5.8% 9/156 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group	5.5% 8/146 • Serious adverse events were collected from the start of investigational product until follow-up contact (up to 61 weeks). Other (non-serious) adverse events were collected from Baseline through Week 54. Baseline for other (non-serious) adverse events: Week 2 for ropinirole PR-ropinirole PR group, Week 0 for ropinirole IR-ropinirole PR group

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER