A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

Measure	Time frame	Description
Rate of Progression of Joint Space Narrowing	Baseline up to Month 24	Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	Baseline up to Month 24	Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.
Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	Baseline up to Month 24	Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.

Measure	Time frame	Description
Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	Month 24	The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 \[minimum\] to 20 \[maximum\], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 \[minimum\] to 68 \[maximum\], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 \[minimum\] to 5 \[maximum\], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.
EuroQoL-5D Visual Analog Scale Score	Baseline, Month 12, 24	The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.
Number of Participants With Increase in Total Analgesic Medication Use	Month 12, 24	Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.
Number of Participants With Decrease in Total Analgesic Medication Use	Month 12, 24	Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.
Patient Global Impression of Change Score	Month 24	Patient global impression of change was a participant-rated instrument that measured change in participant's overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.
Number of Participants With Joint Space Narrowing Progression	Month 24	JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).
Number of Participants Applicable for Virtual Joint Replacement	Month 24	A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 \[minimum\] to 20 \[maximum\], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 \[minimum\] to 68 \[maximum\], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 \[minimum\] to 4 \[maximum\], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.
Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.
Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition.
Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	Physician assessed the overall impact of arthritis on the participant's daily life. Participant's condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.
Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.
Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.
Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Baseline, Month 3, 6, 12, 18, 24	The KOOS-PS was used to rate participant's opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.
Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.
Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.
Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.
Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.
Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.
Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.
Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.
Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.
Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.
Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Baseline, Month 12, 24	The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.
Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline, Month 12, 24	EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.
Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline, Month 12, 24	EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.
Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline, Month 12, 24	EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.
Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline, Month 12, 24	EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.
Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline, Month 12, 24	EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.

Measure	Time frame	Description
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96	BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.
Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96	—
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to 7-10 days after last dose of study drug (Week 111)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.
Number of Participants With Laboratory Test Abnormalities	Baseline up to Week 111	Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(\<)0.8\lower limit of normal(LLN), platelet: \<0.5\LLN or greater than (\>)1.75\upper limit of normal (ULN), white blood cell (WBC): \<0.6\LLN or \>1.5\ULN, lymphocyte, neutrophil:\<0.8\LLN or \>1.2\ULN, basophil, eosinophil, monocyte:\>1.2\ULN; total bilirubin \>1.5\ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\ULN, total protein, albumin: \<0.8\LLN or \>1.2\ULN; blood urea nitrogen, creatinine:\>1.3\ULN, uric acid \>1.2\ULN; sodium \<0.95\LLN or \>1.05\ULN, potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\LLN or \>1.1\ULN, phosphate \<0.8\LLN or \>1.2\ULN; glucose \<0.6\LLN or \>1.5\ULN, lipase \>1.5\ULN; urine (specific gravity \<1.003 or \>1.030, pH \<4.5 or \>8, glucose, ketones, protein, blood/Hgb greater than or equal to \[\>=\]1); pancreatic amylase \>1.5\ULN.
Number of Participants With Electrocardiogram (ECG) Abnormalities	Baseline, Month 3, 6, 12, 18, 24	Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than \[\>\]140 milliseconds \[msec\]), junctional/paced rhythm, intraventricular conduction delay (\>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (\>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.
Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96	Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.

Arm	Count
SD-6010 50 Milligram (mg) Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.	485
SD-6010 200 mg Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.	486
Placebo Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.	486
Total	1,457

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	41	54	40
Overall Study	Death	2	1	3
Overall Study	Did not Meet Entrance Criteria	1	0	1
Overall Study	Domestic Reasons	7	1	3
Overall Study	Follow-up Visit Not Completed	2	0	1
Overall Study	Jury Duty	1	0	0
Overall Study	Lost to Follow-up	10	8	8
Overall Study	Low Compliance	1	0	1
Overall Study	Physician Decision	2	0	0
Overall Study	Protocol Violation	2	6	4
Overall Study	Relocated Out of Area	5	8	9
Overall Study	Research Site Closure	6	1	8
Overall Study	Sponsor Decision	1	5	1
Overall Study	Surgical Intervention	0	1	2
Overall Study	Withdrawal by Subject	58	47	48
Overall Study	Work Schedule	5	3	1

Characteristic	SD-6010 50 Milligram (mg)	SD-6010 200 mg	Placebo	Total
Age, Continuous	61.0 years STANDARD_DEVIATION 8.7	60.8 years STANDARD_DEVIATION 8.6	61.3 years STANDARD_DEVIATION 9.1	61.0 years STANDARD_DEVIATION 8.8
Gender Female	383 Participants	367 Participants	364 Participants	1114 Participants
Gender Male	102 Participants	119 Participants	122 Participants	343 Participants

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	365 / 482	371 / 485	360 / 485
serious Total, serious adverse events	43 / 482	61 / 485	49 / 485

Primary

Rate of Progression of Joint Space Narrowing

Rate of progression of joint space narrowing (JSN) was defined as narrowing in joint space width (JSW) over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in millimeter per year (mm/year) over a 2 year period was used to assess the rate of progression of JSN. Negative values indicating a worsening of osteoarthritis.

Time frame: Baseline up to Month 24

Population: FAS included all participants randomized to the study. Here, 'number of participants analyzed' (N) signifies participants evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Rate of Progression of Joint Space Narrowing	-0.101 mm/year	Standard Deviation 0.346
SD-0610 200 mg	Rate of Progression of Joint Space Narrowing	-0.125 mm/year	Standard Deviation 0.298
Placebo	Rate of Progression of Joint Space Narrowing	-0.109 mm/year	Standard Deviation 0.261

Comparison: Slopes, 95 percent confidence interval (CI), P-values: Random coefficients mixed-effects model for repeated measures (MMRM) with random intercept and slope for each participant,fixed effects for treatment group,time (years),treatment group\*time interaction,(collapsed)Kellgren and Lawrence Grades (KLG), KLG\*time interaction,geographic region,gender,age,body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha =0.0499.p-value: 0.5087795% CI: [-0.023, 0.046]Mixed Models Analysis

Comparison: Slopes, 95 percent CI, P-values: MMRM with random intercept and slope for each participant, fixed effects for treatment group, time (years), treatment group\*time interaction, (collapsed) KLG, KLG\*time interaction, geographic region, gender, age, body mass index with unstructured covariance matrix for random effects. Statistical hypothesis used Hochberg procedure with 2-sided alpha=0.0499.p-value: 0.75407495% CI: [-0.029, 0.04]Mixed Models Analysis

Primary

Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3

Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.

Time frame: Baseline up to Month 24

Population: FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG =3 and evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	-0.133 mm/year	Standard Deviation 0.352
SD-0610 200 mg	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	-0.162 mm/year	Standard Deviation 0.319
Placebo	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3	-0.136 mm/year	Standard Deviation 0.286

Comparison: Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.p-value: 0.88195% CI: [-0.046, 0.054]Mixed Models Analysis

Comparison: Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.p-value: 0.7895% CI: [-0.056, 0.042]Mixed Models Analysis

Primary

Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2

Rate of progression of JSN was defined as narrowing in joint space width over the course of the study. It was measured radiographically in the medial tibiofemoral of knee of participants with OA. The slope reported in mm/year over a 2 year period was used to assess the rate of progression of JSN. KLG system was a method of classifying the severity of knee OA using five grades (0 \[no severity\] to 4 \[maximum severity\], higher grade indicating worse knee function). Negative values of slope indicating a worsening of osteoarthritis.

Time frame: Baseline up to Month 24

Population: FAS included all participants randomized to the study. Here, 'N' signifies participants with KLG \<=2 and evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	-0.061 mm/year	Standard Deviation 0.335
SD-0610 200 mg	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	-0.069 mm/year	Standard Deviation 0.254
Placebo	Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2	-0.075 mm/year	Standard Deviation 0.221

Comparison: Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.p-value: 0.31295% CI: [-0.022, 0.067]Mixed Models Analysis

Comparison: Slopes, 95 percent CI and P-values were obtained from a random coefficients MMRM with random intercept and slope for each participant, and fixed effects for treatment group, time (years), a treatment group\*time (years) interaction, geographic region, gender, age, and body mass index with an unstructured covariance matrix for the random effects.p-value: 0.32795% CI: [-0.022, 0.067]Mixed Models Analysis

Secondary

Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24

The KOOS-PS was used to rate participant's opinions about the difficulties they experienced with activity due to problems with their knee. It was a 7-item scale, each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Total score was calculated by adding the responses to 7 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health condition.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Baseline (n =432, 423, 428)	42.75 units on a scale	Standard Deviation 14.69
SD-0610 50 Milligram (mg)	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =376, 363, 370)	-3.50 units on a scale	Standard Deviation 12.68
SD-0610 50 Milligram (mg)	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =336, 335, 348)	-5.42 units on a scale	Standard Deviation 13.7
SD-0610 50 Milligram (mg)	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =288, 315, 320)	-7.01 units on a scale	Standard Deviation 14.6
SD-0610 50 Milligram (mg)	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =284, 284, 280)	-8.10 units on a scale	Standard Deviation 16
SD-0610 50 Milligram (mg)	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =272, 272, 278)	-8.49 units on a scale	Standard Deviation 16.06
SD-0610 200 mg	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =272, 272, 278)	-9.01 units on a scale	Standard Deviation 14.74
SD-0610 200 mg	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Baseline (n =432, 423, 428)	41.82 units on a scale	Standard Deviation 13.85
SD-0610 200 mg	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =288, 315, 320)	-7.67 units on a scale	Standard Deviation 13.26
SD-0610 200 mg	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =284, 284, 280)	-7.44 units on a scale	Standard Deviation 14.09
SD-0610 200 mg	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =376, 363, 370)	-4.31 units on a scale	Standard Deviation 11.38
SD-0610 200 mg	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =336, 335, 348)	-5.41 units on a scale	Standard Deviation 13.93
Placebo	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =376, 363, 370)	-5.23 units on a scale	Standard Deviation 11.47
Placebo	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =336, 335, 348)	-6.03 units on a scale	Standard Deviation 14.02
Placebo	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =272, 272, 278)	-9.60 units on a scale	Standard Deviation 15.48
Placebo	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =288, 315, 320)	-7.32 units on a scale	Standard Deviation 13.52
Placebo	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Baseline (n =432, 423, 428)	42.60 units on a scale	Standard Deviation 14.76
Placebo	Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =284, 284, 280)	-7.47 units on a scale	Standard Deviation 15

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLGU\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.03995% CI: [0.08, 3.26]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.39595% CI: [-0.91, 2.3]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.1695% CI: [-0.54, 3.25]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.63895% CI: [-1.44, 2.35]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.53795% CI: [-1.32, 2.54]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*(visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.98895% CI: [-1.9, 1.93]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.96295% CI: [-2.12, 2.22]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.85695% CI: [-1.97, 2.37]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.23795% CI: [-0.9, 3.63]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.47595% CI: [-1.44, 3.09]Mixed Models Analysis

Secondary

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24

The OA pain assessment tool-knee joint constant pain subscale was a 5 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 5 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse constant pain.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 481, 484)	35.25 units on a scale	Standard Deviation 24.83
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 452, 454)	-6.61 units on a scale	Standard Deviation 21.64
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =423, 426, 434)	-7.88 units on a scale	Standard Deviation 23.11
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n = 367, 384, 399)	-11.78 units on a scale	Standard Deviation 23.21
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n = 343, 360, 360)	-11.63 units on a scale	Standard Deviation 23.68
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n = 330, 340, 350)	-11.59 units on a scale	Standard Deviation 23.68
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n = 330, 340, 350)	-12.51 units on a scale	Standard Deviation 23.17
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 481, 484)	33.01 units on a scale	Standard Deviation 24.09
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n = 367, 384, 399)	-10.83 units on a scale	Standard Deviation 21.94
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n = 343, 360, 360)	-9.88 units on a scale	Standard Deviation 22.01
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 452, 454)	-6.41 units on a scale	Standard Deviation 19.44
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =423, 426, 434)	-7.47 units on a scale	Standard Deviation 21.05
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 452, 454)	-6.55 units on a scale	Standard Deviation 19.92
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =423, 426, 434)	-8.25 units on a scale	Standard Deviation 20.55
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n = 330, 340, 350)	-13.15 units on a scale	Standard Deviation 23.37
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n = 367, 384, 399)	-11.75 units on a scale	Standard Deviation 21.85
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 481, 484)	35.21 units on a scale	Standard Deviation 24.45
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n = 343, 360, 360)	-10.62 units on a scale	Standard Deviation 23.82

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.91195% CI: [-2.22, 2.49]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.595% CI: [-3.16, 1.54]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.59695% CI: [-1.81, 3.15]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.97995% CI: [-2.51, 2.44]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.65995% CI: [-3.2, 2.03]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.82395% CI: [-2.89, 2.3]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.38795% CI: [-4.04, 1.57]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.73795% CI: [-3.25, 2.3]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.44395% CI: [-1.73, 3.97]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.58595% CI: [-3.62, 2.04]Mixed Models Analysis

Secondary

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24

The OA pain assessment tool-knee joint intermittent pain subscale score a 6 item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. Overall subscale score was calculated by adding the 6 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse intermittent pain.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 480, 481)	42.76 units on a scale	Standard Deviation 22.85
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 450, 450)	-7.32 units on a scale	Standard Deviation 20.68
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 422, 430)	-10.18 units on a scale	Standard Deviation 22.28
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =365, 385, 397)	-14.15 units on a scale	Standard Deviation 22.93
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 359)	-13.56 units on a scale	Standard Deviation 23.72
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =330, 340, 349)	-14.20 units on a scale	Standard Deviation 23.11
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =330, 340, 349)	-13.17 units on a scale	Standard Deviation 22.74
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 480, 481)	39.44 units on a scale	Standard Deviation 21.46
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =365, 385, 397)	-10.93 units on a scale	Standard Deviation 21.86
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 359)	-9.45 units on a scale	Standard Deviation 23.07
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 450, 450)	-6.93 units on a scale	Standard Deviation 18.95
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 422, 430)	-7.96 units on a scale	Standard Deviation 20.34
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 450, 450)	-7.48 units on a scale	Standard Deviation 19.28
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 422, 430)	-8.31 units on a scale	Standard Deviation 21.44
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =330, 340, 349)	-14.27 units on a scale	Standard Deviation 22.66
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =365, 385, 397)	-12.54 units on a scale	Standard Deviation 21.64
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 480, 481)	41.73 units on a scale	Standard Deviation 22.1
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 359)	-11.69 units on a scale	Standard Deviation 23.02

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.61395% CI: [-1.68, 2.85]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.6795% CI: [-2.76, 1.78]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.29695% CI: [-3.82, 1.16]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.60495% CI: [-3.15, 1.83]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.16395% CI: [-4.46, 0.75]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.93995% CI: [-2.69, 2.48]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.23395% CI: [-4.61, 1.12]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.7295% CI: [-2.32, 3.36]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.99395% CI: [-2.82, 2.85]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.79495% CI: [-3.19, 2.44]Mixed Models Analysis

Secondary

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24

The OA pain and assessment tool-knee joint is also known as the intermittent and constant osteoarthritis pain (ICOAP) scale. The OA pain assessment tool-knee joint was an 11-item scale, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was calculated by adding the 11 items and rescaled to a 0 (minimum) to 100 (maximum) scale, where higher scores indicating worse health.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluated for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 480, 481)	39.35 units on a scale	Standard Deviation 23.06
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 450, 449)	-7.00 units on a scale	Standard Deviation 19.95
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 422, 430)	-9.09 units on a scale	Standard Deviation 21.43
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n = 365, 384, 397)	-13.00 units on a scale	Standard Deviation 21.93
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 359)	-12.71 units on a scale	Standard Deviation 22.64
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =330, 340, 349)	-13.02 units on a scale	Standard Deviation 22.3
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =330, 340, 349)	-12.87 units on a scale	Standard Deviation 21.53
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 480, 481)	36.55 units on a scale	Standard Deviation 21.78
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n = 365, 384, 397)	-10.84 units on a scale	Standard Deviation 20.58
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 359)	-9.59 units on a scale	Standard Deviation 21.26
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 450, 449)	-6.68 units on a scale	Standard Deviation 17.77
SD-0610 200 mg	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 422, 430)	-7.74 units on a scale	Standard Deviation 19.36
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =448, 450, 449)	-7.08 units on a scale	Standard Deviation 18.15
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 422, 430)	-8.27 units on a scale	Standard Deviation 19.68
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =330, 340, 349)	-13.79 units on a scale	Standard Deviation 21.81
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n = 365, 384, 397)	-12.26 units on a scale	Standard Deviation 20.24
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Baseline (n =479, 480, 481)	38.79 units on a scale	Standard Deviation 22.29
Placebo	Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 359)	-11.23 units on a scale	Standard Deviation 22.13

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.73895% CI: [-1.8, 2.55]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.63295% CI: [-2.7, 1.64]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.73695% CI: [-2.77, 1.96]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.81195% CI: [-2.66, 2.08]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.33595% CI: [-3.71, 1.26]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.96695% CI: [-2.52, 2.41]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.29995% CI: [-4.16, 1.28]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.92595% CI: [-2.56, 2.82]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.67695% CI: [-2.14, 3.3]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.73295% CI: [-3.18, 2.23]Mixed Models Analysis

Secondary

Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24

The OARSI knee function survey was an 11-item scale with each item scored 0 (minimum) to 4 (maximum), where 4 indicated worst health condition. The total score was the sum of the 11 items and ranged from 0 (minimum) to 44 (maximum), where higher scores indicating worse health condition.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Baseline (n =382, 376, 391)	22.19 units on a scale	Standard Deviation 8.96
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n = 309, 304, 315)	-2.20 units on a scale	Standard Deviation 7.7
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =270, 283, 294)	-3.24 units on a scale	Standard Deviation 8.42
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =240, 263, 266)	-4.57 units on a scale	Standard Deviation 8.65
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =225, 239, 243)	-5.14 units on a scale	Standard Deviation 9.37
SD-0610 50 Milligram (mg)	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 24(n = 227, 224, 237)	-5.31 units on a scale	Standard Deviation 9.4
SD-0610 200 mg	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 24(n = 227, 224, 237)	-5.13 units on a scale	Standard Deviation 8.36
SD-0610 200 mg	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Baseline (n =382, 376, 391)	21.49 units on a scale	Standard Deviation 8.59
SD-0610 200 mg	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =240, 263, 266)	-4.35 units on a scale	Standard Deviation 7.76
SD-0610 200 mg	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =225, 239, 243)	-4.61 units on a scale	Standard Deviation 8.56
SD-0610 200 mg	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n = 309, 304, 315)	-2.24 units on a scale	Standard Deviation 6.57
SD-0610 200 mg	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =270, 283, 294)	-3.29 units on a scale	Standard Deviation 7.8
Placebo	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n = 309, 304, 315)	-2.99 units on a scale	Standard Deviation 7.12
Placebo	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =270, 283, 294)	-3.53 units on a scale	Standard Deviation 8.26
Placebo	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 24(n = 227, 224, 237)	-5.62 units on a scale	Standard Deviation 9.28
Placebo	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =240, 263, 266)	-4.46 units on a scale	Standard Deviation 7.99
Placebo	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Baseline (n =382, 376, 391)	21.80 units on a scale	Standard Deviation 8.92
Placebo	Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =225, 239, 243)	-4.93 units on a scale	Standard Deviation 9.22

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.06995% CI: [-0.07, 2.02]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.33595% CI: [-0.53, 1.57]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.15395% CI: [-0.33, 2.11]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.67295% CI: [-0.95, 1.47]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.76595% CI: [-1.05, 1.43]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.67595% CI: [-0.96, 1.49]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.5695% CI: [-1, 1.84]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.43395% CI: [-0.84, 1.97]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.31895% CI: [-0.7, 2.16]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.30395% CI: [-0.68, 2.18]Mixed Models Analysis

Secondary

Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24

The pain VAS following a 50 foot walk was a single-item, self-administered instrument. Participants were asked to assess the pain due to OA in their study knee after a 50-foot walk. Participants responded on a VAS scale ranging from 0 (no pain) to 100 (severe pain). Higher scores indicating more pain.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Baseline (n =480, 483, 482)	38.03 units on a scale	Standard Deviation 26.39
SD-0610 50 Milligram (mg)	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =446, 453, 456)	-5.78 units on a scale	Standard Deviation 25.3
SD-0610 50 Milligram (mg)	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 428, 436)	-8.13 units on a scale	Standard Deviation 25.86
SD-0610 50 Milligram (mg)	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 382, 397)	-11.32 units on a scale	Standard Deviation 27.42
SD-0610 50 Milligram (mg)	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n = 345, 360, 357)	-11.17 units on a scale	Standard Deviation 27.51
SD-0610 50 Milligram (mg)	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 340, 351)	-12.31 units on a scale	Standard Deviation 27.61
SD-0610 200 mg	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 340, 351)	-12.86 units on a scale	Standard Deviation 26.73
SD-0610 200 mg	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Baseline (n =480, 483, 482)	35.13 units on a scale	Standard Deviation 26.1
SD-0610 200 mg	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 382, 397)	-10.07 units on a scale	Standard Deviation 25.22
SD-0610 200 mg	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n = 345, 360, 357)	-8.91 units on a scale	Standard Deviation 27.12
SD-0610 200 mg	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =446, 453, 456)	-5.71 units on a scale	Standard Deviation 23.2
SD-0610 200 mg	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 428, 436)	-7.17 units on a scale	Standard Deviation 25.42
Placebo	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =446, 453, 456)	-7.45 units on a scale	Standard Deviation 23.15
Placebo	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 428, 436)	-8.78 units on a scale	Standard Deviation 25.67
Placebo	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 340, 351)	-13.77 units on a scale	Standard Deviation 24.53
Placebo	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 382, 397)	-11.91 units on a scale	Standard Deviation 24.04
Placebo	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Baseline (n =480, 483, 482)	38.00 units on a scale	Standard Deviation 25.73
Placebo	Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n = 345, 360, 357)	-11.86 units on a scale	Standard Deviation 26.04

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.2295% CI: [-1, 4.36]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.99795% CI: [-2.67, 2.68]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.61395% CI: [-2.09, 3.55]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.96495% CI: [-2.75, 2.88]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.87295% CI: [-2.69, 3.17]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.94795% CI: [-2.81, 3.01]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.92795% CI: [-3.03, 3.33]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.54795% CI: [-2.18, 4.12]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.30495% CI: [-1.47, 4.71]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.67995% CI: [-3.73, 2.43]Mixed Models Analysis

Secondary

Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24

Pain VAS was a self-administered instrument, a 100 millimeter (mm) line marked by participant. Intensity of pain range (over past week): 0 (mm) =no pain to 100 (mm) =worst possible pain. Higher score indicating severe pain.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =333, 338, 348)	-14.59 mm	Standard Deviation 28.36
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 424, 435)	-10.13 mm	Standard Deviation 24.91
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 360, 360)	-13.99 mm	Standard Deviation 26.78
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Baseline (n =478, 479, 482)	40.19 mm	Standard Deviation 24.77
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 384, 396)	-11.75 mm	Standard Deviation 30.38
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =446, 448, 455)	-7.21 mm	Standard Deviation 25.49
SD-0610 200 mg	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 384, 396)	-10.98 mm	Standard Deviation 25.28
SD-0610 200 mg	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 360, 360)	-11.17 mm	Standard Deviation 25.6
SD-0610 200 mg	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =446, 448, 455)	-7.02 mm	Standard Deviation 23.45
SD-0610 200 mg	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =333, 338, 348)	-13.36 mm	Standard Deviation 25.69
SD-0610 200 mg	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Baseline (n =478, 479, 482)	37.59 mm	Standard Deviation 24.26
SD-0610 200 mg	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 424, 435)	-7.92 mm	Standard Deviation 24.9
Placebo	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =333, 338, 348)	-13.29 mm	Standard Deviation 23.97
Placebo	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Baseline (n =478, 479, 482)	39.37 mm	Standard Deviation 23.91
Placebo	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =446, 448, 455)	-9.12 mm	Standard Deviation 21.72
Placebo	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =422, 424, 435)	-10.17 mm	Standard Deviation 24.07
Placebo	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 384, 396)	-12.97 mm	Standard Deviation 24.26
Placebo	Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 360, 360)	-12.86 mm	Standard Deviation 26.47

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.08695% CI: [-0.33, 5.01]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.41595% CI: [-1.56, 3.78]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.56995% CI: [-1.97, 3.57]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.37495% CI: [-1.51, 4.02]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.28895% CI: [-1.38, 4.64]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.4495% CI: [-1.81, 4.17]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.89695% CI: [-3.3, 2.88]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.46495% CI: [-1.92, 4.2]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.90195% CI: [-3.27, 2.88]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.895% CI: [-3.45, 2.66]Mixed Models Analysis

Secondary

Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24

Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using the scale ranging from 1 (minimum) to 5 (maximum), where 1 =very good, 2 =good, 3 =fair, 4 =poor and 5 =very poor. Higher scores indicating worse condition.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 483)	2.684 units on a scale	Standard Deviation 0.904
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 452, 455)	-0.232 units on a scale	Standard Deviation 0.909
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 427, 435)	-0.337 units on a scale	Standard Deviation 0.876
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =368, 385, 397)	-0.405 units on a scale	Standard Deviation 0.908
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 358)	-0.442 units on a scale	Standard Deviation 0.979
SD-0610 50 Milligram (mg)	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =335, 340, 351)	-0.513 units on a scale	Standard Deviation 0.95
SD-0610 200 mg	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =335, 340, 351)	-0.488 units on a scale	Standard Deviation 0.939
SD-0610 200 mg	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 483)	2.610 units on a scale	Standard Deviation 0.883
SD-0610 200 mg	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =368, 385, 397)	-0.371 units on a scale	Standard Deviation 0.93
SD-0610 200 mg	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 358)	-0.418 units on a scale	Standard Deviation 0.934
SD-0610 200 mg	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 452, 455)	-0.230 units on a scale	Standard Deviation 0.816
SD-0610 200 mg	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 427, 435)	-0.319 units on a scale	Standard Deviation 0.857
Placebo	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 452, 455)	-0.202 units on a scale	Standard Deviation 0.787
Placebo	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 427, 435)	-0.260 units on a scale	Standard Deviation 0.879
Placebo	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =335, 340, 351)	-0.473 units on a scale	Standard Deviation 0.934
Placebo	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =368, 385, 397)	-0.370 units on a scale	Standard Deviation 0.848
Placebo	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 483)	2.634 units on a scale	Standard Deviation 0.883
Placebo	Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 358)	-0.388 units on a scale	Standard Deviation 0.903

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.98495% CI: [-0.093, 0.095]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.3395% CI: [-0.14, 0.047]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.30895% CI: [-0.146, 0.046]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.08995% CI: [-0.18, 0.013]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.50895% CI: [-0.137, 0.068]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.4995% CI: [-0.137, 0.066]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.73995% CI: [-0.132, 0.094]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.37695% CI: [-0.162, 0.061]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.88395% CI: [-0.121, 0.104]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.6995% CI: [-0.135, 0.089]Mixed Models Analysis

Secondary

Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24

Physician assessed the overall impact of arthritis on the participant's daily life. Participant's condition was rated by the physician using the scale ranging from 1 (minimum) to 5 (maximum), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicating worse condition.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline (n =480, 483, 480)	2.785 units on a scale	Standard Deviation 0.679
SD-0610 50 Milligram (mg)	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 448, 453)	-0.379 units on a scale	Standard Deviation 0.782
SD-0610 50 Milligram (mg)	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =420, 426, 431)	-0.443 units on a scale	Standard Deviation 0.823
SD-0610 50 Milligram (mg)	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =367, 386, 396)	-0.548 units on a scale	Standard Deviation 0.873
SD-0610 50 Milligram (mg)	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 355)	-0.602 units on a scale	Standard Deviation 0.906
SD-0610 50 Milligram (mg)	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n = 331, 340, 349)	-0.656 units on a scale	Standard Deviation 0.906
SD-0610 200 mg	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n = 331, 340, 349)	-0.662 units on a scale	Standard Deviation 0.879
SD-0610 200 mg	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline (n =480, 483, 480)	2.834 units on a scale	Standard Deviation 0.689
SD-0610 200 mg	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =367, 386, 396)	-0.627 units on a scale	Standard Deviation 0.859
SD-0610 200 mg	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 355)	-0.643 units on a scale	Standard Deviation 0.833
SD-0610 200 mg	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 448, 453)	-0.422 units on a scale	Standard Deviation 0.756
SD-0610 200 mg	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =420, 426, 431)	-0.561 units on a scale	Standard Deviation 0.841
Placebo	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 448, 453)	-0.415 units on a scale	Standard Deviation 0.764
Placebo	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =420, 426, 431)	-0.452 units on a scale	Standard Deviation 0.791
Placebo	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n = 331, 340, 349)	-0.711 units on a scale	Standard Deviation 0.867
Placebo	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =367, 386, 396)	-0.535 units on a scale	Standard Deviation 0.828
Placebo	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Baseline (n =480, 483, 480)	2.831 units on a scale	Standard Deviation 0.655
Placebo	Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =342, 359, 355)	-0.628 units on a scale	Standard Deviation 0.862

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.84995% CI: [-0.078, 0.095]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.83795% CI: [-0.096, 0.078]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.77695% CI: [-0.105, 0.078]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.03395% CI: [-0.191, -0.008]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.20195% CI: [-0.163, 0.034]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.03895% CI: [-0.201, -0.006]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.84895% CI: [-0.114, 0.094]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.71495% CI: [-0.122, 0.084]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.65295% CI: [-0.082, 0.131]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.795% CI: [-0.085, 0.127]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 19.23 (minimum) to 60.88 (maximum), with higher scores indicating lower bodily pain.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	4.07 units on a scale	Standard Deviation 9.64
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	38.81 units on a scale	Standard Deviation 8.63
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Change at Month 24 (n =332, 341, 352)	4.25 units on a scale	Standard Deviation 9.54
SD-0610 200 mg	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	3.72 units on a scale	Standard Deviation 8.32
SD-0610 200 mg	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	39.77 units on a scale	Standard Deviation 8.34
SD-0610 200 mg	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Change at Month 24 (n =332, 341, 352)	4.65 units on a scale	Standard Deviation 9.9
Placebo	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	38.90 units on a scale	Standard Deviation 8.22
Placebo	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Change at Month 24 (n =332, 341, 352)	4.46 units on a scale	Standard Deviation 9.44
Placebo	Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	4.06 units on a scale	Standard Deviation 8.97

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.58795% CI: [-0.84, 1.48]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.68795% CI: [-0.91, 1.38]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.67795% CI: [-1.56, 1.01]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.46995% CI: [-0.8, 1.74]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.75 (minimum) to 63.72 (maximum), with higher scores indicating better general health.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Change at Month 24 (n =331, 341, 352)	1.13 units on a scale	Standard Deviation 8.43
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	1.33 units on a scale	Standard Deviation 7.52
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	44.77 units on a scale	Standard Deviation 10.15
SD-0610 200 mg	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Change at Month 24 (n =331, 341, 352)	0.40 units on a scale	Standard Deviation 7.76
SD-0610 200 mg	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	1.10 units on a scale	Standard Deviation 7.64
SD-0610 200 mg	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	46.49 units on a scale	Standard Deviation 9.79
Placebo	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	1.20 units on a scale	Standard Deviation 6.93
Placebo	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	45.19 units on a scale	Standard Deviation 9.63
Placebo	Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24	Change at Month 24 (n =331, 341, 352)	1.25 units on a scale	Standard Deviation 7.77

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.63295% CI: [-0.71, 1.17]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.30895% CI: [-0.45, 1.42]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.61595% CI: [-1.33, 0.79]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.42595% CI: [-1.48, 0.62]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 11.11 (minimum) to 61.67 (maximum), with higher scores indicating better mental health.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	-0.13 units on a scale	Standard Deviation 10.64
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Baseline (n =481, 480, 483)	49.65 units on a scale	Standard Deviation 11.79
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Change at Month 24 (n =329, 340, 351)	-0.41 units on a scale	Standard Deviation 11.24
SD-0610 200 mg	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	-1.17 units on a scale	Standard Deviation 9.48
SD-0610 200 mg	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Baseline (n =481, 480, 483)	49.97 units on a scale	Standard Deviation 11.11
SD-0610 200 mg	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Change at Month 24 (n =329, 340, 351)	-0.70 units on a scale	Standard Deviation 10.08
Placebo	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Baseline (n =481, 480, 483)	49.65 units on a scale	Standard Deviation 11.62
Placebo	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Change at Month 24 (n =329, 340, 351)	-1.09 units on a scale	Standard Deviation 10.18
Placebo	Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	-1.27 units on a scale	Standard Deviation 9.65

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.02395% CI: [0.19, 2.65]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.39195% CI: [-0.68, 1.75]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.14295% CI: [-0.34, 2.37]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.20495% CI: [-0.47, 2.21]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 8.02 (minimum) to 63.43 (maximum), with higher scores indicating better mental health.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	0.95 units on a scale	Standard Deviation 10.08
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	47.01 units on a scale	Standard Deviation 10.8
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Change at Month 24 (n =332, 340, 351)	1.12 units on a scale	Standard Deviation 10.26
SD-0610 200 mg	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	0.19 units on a scale	Standard Deviation 9.1
SD-0610 200 mg	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	47.70 units on a scale	Standard Deviation 10.73
SD-0610 200 mg	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Change at Month 24 (n =332, 340, 351)	0.26 units on a scale	Standard Deviation 10.01
Placebo	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	47.26 units on a scale	Standard Deviation 11.15
Placebo	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Change at Month 24 (n =332, 340, 351)	-0.01 units on a scale	Standard Deviation 9.81
Placebo	Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	-0.31 units on a scale	Standard Deviation 9.5

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.05895% CI: [-0.04, 2.38]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.21395% CI: [-0.44, 1.96]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.14395% CI: [-0.33, 2.3]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.4595% CI: [-0.8, 1.81]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.88 (minimum) to 58.69 (maximum), with higher scores indicating better physical health.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	3.26 units on a scale	Standard Deviation 7.98
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Baseline (n =481, 480, 483)	37.38 units on a scale	Standard Deviation 8.84
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Change at Month 24 (n =329, 340, 351)	3.77 units on a scale	Standard Deviation 8.48
SD-0610 200 mg	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	3.31 units on a scale	Standard Deviation 7.69
SD-0610 200 mg	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Baseline (n =481, 480, 483)	38.69 units on a scale	Standard Deviation 8.35
SD-0610 200 mg	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Change at Month 24 (n =329, 340, 351)	3.66 units on a scale	Standard Deviation 8.32
Placebo	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Baseline (n =481, 480, 483)	37.84 units on a scale	Standard Deviation 8.46
Placebo	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Change at Month 24 (n =329, 340, 351)	4.18 units on a scale	Standard Deviation 8.48
Placebo	Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24	Change at Month 12 (n =367, 381, 395)	3.58 units on a scale	Standard Deviation 7.87

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.70195% CI: [-1.19, 0.8]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.76495% CI: [-0.84, 1.14]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.22895% CI: [-1.8, 0.43]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.51495% CI: [-1.47, 0.74]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 10.25 (minimum) to 55.68 (maximum), with higher scores indicating better role-emotional.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	0.05 units on a scale	Standard Deviation 12.06
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	43.73 units on a scale	Standard Deviation 12.79
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	-0.28 units on a scale	Standard Deviation 12.77
SD-0610 200 mg	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	-0.18 units on a scale	Standard Deviation 10.55
SD-0610 200 mg	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	43.27 units on a scale	Standard Deviation 12.09
SD-0610 200 mg	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	0.60 units on a scale	Standard Deviation 11.69
Placebo	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	43.37 units on a scale	Standard Deviation 12.35
Placebo	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	0.32 units on a scale	Standard Deviation 11.98
Placebo	Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	-0.25 units on a scale	Standard Deviation 11.47

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.13395% CI: [-0.32, 2.44]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.52495% CI: [-0.93, 1.82]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.74395% CI: [-1.27, 1.78]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.3195% CI: [-0.73, 2.3]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 18.45 (minimum) to 56.62 (maximum), with higher scores indicating better role-physical.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	2.06 units on a scale	Standard Deviation 9.55
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	39.99 units on a scale	Standard Deviation 9.85
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	2.44 units on a scale	Standard Deviation 9.53
SD-0610 200 mg	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	2.35 units on a scale	Standard Deviation 8.75
SD-0610 200 mg	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	40.37 units on a scale	Standard Deviation 9.73
SD-0610 200 mg	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	2.44 units on a scale	Standard Deviation 9.34
Placebo	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	40.14 units on a scale	Standard Deviation 10.03
Placebo	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	2.70 units on a scale	Standard Deviation 9.35
Placebo	Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	2.22 units on a scale	Standard Deviation 8.85

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.995% CI: [-1.07, 1.21]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.52895% CI: [-0.77, 1.5]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.64795% CI: [-1.51, 0.94]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.84195% CI: [-1.34, 1.09]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 16.18 (minimum) to 57.11 (maximum), with higher scores indicating better physical functioning.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	2.59 units on a scale	Standard Deviation 8.8
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	35.67 units on a scale	Standard Deviation 9.74
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Change at Month 24 (n =332, 341, 352)	3.53 units on a scale	Standard Deviation 9.5
SD-0610 200 mg	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	2.41 units on a scale	Standard Deviation 8.66
SD-0610 200 mg	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	36.84 units on a scale	Standard Deviation 9.42
SD-0610 200 mg	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Change at Month 24 (n =332, 341, 352)	3.23 units on a scale	Standard Deviation 9.66
Placebo	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	36.32 units on a scale	Standard Deviation 9.15
Placebo	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Change at Month 24 (n =332, 341, 352)	3.51 units on a scale	Standard Deviation 9.54
Placebo	Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	2.55 units on a scale	Standard Deviation 8.84

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.93895% CI: [-1.07, 1.16]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.90695% CI: [-1.04, 1.17]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.72695% CI: [-1.5, 1.04]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.68195% CI: [-1.52, 1]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 13.38 (minimum) to 56.40 (maximum), with higher scores indicating better social functioning.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	1.11 units on a scale	Standard Deviation 10.28
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	45.15 units on a scale	Standard Deviation 11.06
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	1.31 units on a scale	Standard Deviation 10.62
SD-0610 200 mg	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	-0.28 units on a scale	Standard Deviation 9.16
SD-0610 200 mg	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	46.23 units on a scale	Standard Deviation 10.19
SD-0610 200 mg	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	0.88 units on a scale	Standard Deviation 10.15
Placebo	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Baseline (n =481, 482, 485)	45.64 units on a scale	Standard Deviation 10.36
Placebo	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Change at Month 24 (n =333, 341, 352)	0.12 units on a scale	Standard Deviation 10.03
Placebo	Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 397)	-0.15 units on a scale	Standard Deviation 9.74

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.0395% CI: [0.13, 2.52]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.4895% CI: [-0.76, 1.61]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.13295% CI: [-0.3, 2.32]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.11795% CI: [-0.26, 2.34]Mixed Models Analysis

Secondary

Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24

The SF-36 was a participant administered scale assessing general quality of life. It consisted of self-administered 36-item questionnaire that measured 8 health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. These 8 domains were also summarized as physical and mental component scores. The score for each domain and component score was the mean of the individual question scores, which were scaled from 0 (minimum) to 100 (maximum), where higher scores indicated highest level of health/functioning. Linear transformations were performed to transform scores and rescaled to a score range of 22.02 (minimum) to 69.92 (maximum), with higher scores indicating better vitality.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	1.52 units on a scale	Standard Deviation 8.51
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	47.57 units on a scale	Standard Deviation 9.44
SD-0610 50 Milligram (mg)	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Change at Month 24 (n =332, 340, 351)	1.53 units on a scale	Standard Deviation 8.71
SD-0610 200 mg	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	0.48 units on a scale	Standard Deviation 8.04
SD-0610 200 mg	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	49.00 units on a scale	Standard Deviation 9.2
SD-0610 200 mg	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Change at Month 24 (n =332, 340, 351)	0.78 units on a scale	Standard Deviation 8.62
Placebo	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Baseline (n =481, 481, 484)	48.08 units on a scale	Standard Deviation 9.53
Placebo	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Change at Month 24 (n =332, 340, 351)	1.42 units on a scale	Standard Deviation 8.7
Placebo	Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24	Change at Month 12 (n =368, 381, 396)	1.04 units on a scale	Standard Deviation 8.22

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.21495% CI: [-0.39, 1.72]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.9895% CI: [-1.06, 1.03]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.57595% CI: [-0.83, 1.49]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.98695% CI: [-1.16, 1.14]Mixed Models Analysis

Secondary

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24

Stiffness was defined as a sensation of decreased ease in which the participant moved the knee with OA. The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 342, 349)	-0.94 units on a scale	Standard Deviation 1.95
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =425, 429, 434)	-0.67 units on a scale	Standard Deviation 1.7
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =346, 363, 358)	-0.88 units on a scale	Standard Deviation 1.86
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 484, 482)	3.48 units on a scale	Standard Deviation 1.8
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =371, 389, 397)	-0.89 units on a scale	Standard Deviation 1.89
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 455, 456)	-0.52 units on a scale	Standard Deviation 1.67
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =371, 389, 397)	-0.79 units on a scale	Standard Deviation 1.83
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =346, 363, 358)	-0.87 units on a scale	Standard Deviation 1.88
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 455, 456)	-0.51 units on a scale	Standard Deviation 1.58
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 342, 349)	-1.10 units on a scale	Standard Deviation 1.95
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 484, 482)	3.33 units on a scale	Standard Deviation 1.78
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =425, 429, 434)	-0.56 units on a scale	Standard Deviation 1.78
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =425, 429, 434)	-0.62 units on a scale	Standard Deviation 1.73
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 484, 482)	3.44 units on a scale	Standard Deviation 1.77
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 455, 456)	-0.51 units on a scale	Standard Deviation 1.58
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 342, 349)	-0.95 units on a scale	Standard Deviation 1.92
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =371, 389, 397)	-0.95 units on a scale	Standard Deviation 1.78
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =346, 363, 358)	-0.82 units on a scale	Standard Deviation 1.82

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.90495% CI: [-0.17, 0.2]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.58295% CI: [-0.24, 0.13]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.81895% CI: [-0.22, 0.18]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG x visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.98895% CI: [-0.2, 0.2]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.85795% CI: [-0.2, 0.24]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.65895% CI: [-0.17, 0.27]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.61295% CI: [-0.28, 0.17]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.39195% CI: [-0.32, 0.13]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 195% CI: [-0.24, 0.24]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.08695% CI: [-0.45, 0.03]Mixed Models Analysis

Secondary

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24

The WOMAC pain subscale was comprised of 5 questions regarding the amount of pain experienced due to OA in the study knee. The WOMAC pain subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse pain. An overall subscale score range of 0 (minimum) to 20 (maximum), with higher scores indicating more pain.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =482, 484, 483)	7.96 units on a scale	Standard Deviation 3.94
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =451, 453, 458)	-1.32 units on a scale	Standard Deviation 3.41
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =426, 429, 435)	-1.73 units on a scale	Standard Deviation 3.73
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =372, 389, 398)	-2.17 units on a scale	Standard Deviation 4.25
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =347, 363, 359)	-2.24 units on a scale	Standard Deviation 4.16
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =337, 342, 351)	-2.48 units on a scale	Standard Deviation 4.02
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =337, 342, 351)	-2.23 units on a scale	Standard Deviation 4.16
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =482, 484, 483)	7.44 units on a scale	Standard Deviation 3.87
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =372, 389, 398)	-2.10 units on a scale	Standard Deviation 3.66
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =347, 363, 359)	-2.00 units on a scale	Standard Deviation 3.93
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =451, 453, 458)	-1.23 units on a scale	Standard Deviation 3.19
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =426, 429, 435)	-1.42 units on a scale	Standard Deviation 3.58
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =451, 453, 458)	-1.25 units on a scale	Standard Deviation 3.15
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =426, 429, 435)	-1.59 units on a scale	Standard Deviation 3.45
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =337, 342, 351)	-2.19 units on a scale	Standard Deviation 3.79
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =372, 389, 398)	-2.08 units on a scale	Standard Deviation 3.47
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =482, 484, 483)	7.59 units on a scale	Standard Deviation 4.03
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =347, 363, 359)	-1.86 units on a scale	Standard Deviation 3.88

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.68395% CI: [-0.3, 0.46]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.85395% CI: [-0.42, 0.35]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\* visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.93895% CI: [-0.41, 0.44]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.64895% CI: [-0.32, 0.52]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.91695% CI: [-0.49, 0.44]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.52895% CI: [-0.6, 0.31]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.36595% CI: [-0.73, 0.27]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.32895% CI: [-0.74, 0.25]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.5495% CI: [-0.66, 0.35]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.42395% CI: [-0.71, 0.3]Mixed Models Analysis

Secondary

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24

The WOMAC physical function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC physical function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 482)	27.63 units on a scale	Standard Deviation 13.88
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 452, 456)	-3.50 units on a scale	Standard Deviation 10.77
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 426, 434)	-4.78 units on a scale	Standard Deviation 11.73
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 388, 398)	-6.09 units on a scale	Standard Deviation 13.21
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 358)	-6.74 units on a scale	Standard Deviation 12.95
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 339, 350)	-7.42 units on a scale	Standard Deviation 13.47
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 339, 350)	-7.65 units on a scale	Standard Deviation 12.37
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 482)	26.49 units on a scale	Standard Deviation 13.18
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 388, 398)	-6.37 units on a scale	Standard Deviation 11.34
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 358)	-5.49 units on a scale	Standard Deviation 12.05
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 452, 456)	-3.24 units on a scale	Standard Deviation 9.71
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 426, 434)	-3.86 units on a scale	Standard Deviation 10.81
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 452, 456)	-3.72 units on a scale	Standard Deviation 9.99
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 426, 434)	-4.82 units on a scale	Standard Deviation 11.43
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 339, 350)	-7.35 units on a scale	Standard Deviation 12.54
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 388, 398)	-6.79 units on a scale	Standard Deviation 11.55
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 482)	27.39 units on a scale	Standard Deviation 13.81
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 358)	-6.12 units on a scale	Standard Deviation 13.22

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.58695% CI: [-0.88, 1.55]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.78995% CI: [-1.05, 1.38]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.82195% CI: [-1.21, 1.52]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.29495% CI: [-0.63, 2.09]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.53295% CI: [-1.02, 1.97]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.93895% CI: [-1.55, 1.43]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.6895% CI: [-1.97, 1.29]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.7395% CI: [-1.33, 1.9]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.90195% CI: [-1.55, 1.76]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.33395% CI: [-2.45, 0.83]Mixed Models Analysis

Secondary

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24

The WOMAC was a self-administered, disease-specific instrument which probed clinically important, participant relevant symptoms in the areas of pain, stiffness, and physical function in participants with OA of the knee. The WOMAC composite index was the sum of 24 individual questions regarding subscales of pain, stiffness and physical function (for each item score range: 0 \[minimum\] to 4 \[maximum\], higher score indicating worse knee condition). Total score was sum of the 3 subscale scores, giving a possible overall score range of 0 (minimum) to 96 (maximum). Higher score indicating the worse level of pain, stiffness and physical function.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 481)	39.07 units on a scale	Standard Deviation 18.85
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 450, 455)	-5.35 units on a scale	Standard Deviation 14.73
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 426, 433)	-7.20 units on a scale	Standard Deviation 15.99
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 388, 397)	-9.17 units on a scale	Standard Deviation 18.19
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 357)	-9.91 units on a scale	Standard Deviation 17.98
SD-0610 50 Milligram (mg)	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 339, 349)	-10.85 units on a scale	Standard Deviation 18.49
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 339, 349)	-10.98 units on a scale	Standard Deviation 17.62
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 481)	37.29 units on a scale	Standard Deviation 17.98
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 388, 397)	-9.25 units on a scale	Standard Deviation 15.82
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 357)	-8.35 units on a scale	Standard Deviation 16.87
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 450, 455)	-5.08 units on a scale	Standard Deviation 13.14
SD-0610 200 mg	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 426, 433)	-5.84 units on a scale	Standard Deviation 15.15
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 3 (n =449, 450, 455)	-5.50 units on a scale	Standard Deviation 13.59
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 6 (n =424, 426, 433)	-7.07 units on a scale	Standard Deviation 15.62
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 24 (n =336, 339, 349)	-10.49 units on a scale	Standard Deviation 17.26
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 12 (n =370, 388, 397)	-9.84 units on a scale	Standard Deviation 15.75
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Baseline (n =481, 482, 481)	38.45 units on a scale	Standard Deviation 18.91
Placebo	Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24	Change at Month 18 (n =344, 361, 357)	-8.82 units on a scale	Standard Deviation 18

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.36595% CI: [-1.01, 2.76]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.63995% CI: [-1.26, 2.05]Mixed Models Analysis

Comparison: Month 3; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.95795% CI: [-1.61, 1.7]Mixed Models Analysis

Comparison: Month 6; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.89395% CI: [-1.76, 2.01]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.67895% CI: [-1.63, 2.51]Mixed Models Analysis

Comparison: Month 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.90295% CI: [-2.18, 1.93]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.57795% CI: [-2.89, 1.61]Mixed Models Analysis

Comparison: Month 18; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.9895% CI: [-2.26, 2.21]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.9595% CI: [-2.37, 2.23]Mixed Models Analysis

Comparison: Month 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit,a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value,geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.29295% CI: [-3.53, 1.06]Mixed Models Analysis

Secondary

EuroQoL-5D Visual Analog Scale Score

The EQ-5D VAS score was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	EuroQoL-5D Visual Analog Scale Score	Month 12 (n =369, 381, 399)	72.34 units on a scale	Standard Deviation 19.01
SD-0610 50 Milligram (mg)	EuroQoL-5D Visual Analog Scale Score	Baseline (n =480, 479, 484)	66.75 units on a scale	Standard Deviation 21.52
SD-0610 50 Milligram (mg)	EuroQoL-5D Visual Analog Scale Score	Month 24 (n =334, 341, 352)	73.18 units on a scale	Standard Deviation 19.64
SD-0610 200 mg	EuroQoL-5D Visual Analog Scale Score	Month 12 (n =369, 381, 399)	72.55 units on a scale	Standard Deviation 19.48
SD-0610 200 mg	EuroQoL-5D Visual Analog Scale Score	Baseline (n =480, 479, 484)	68.59 units on a scale	Standard Deviation 19.69
SD-0610 200 mg	EuroQoL-5D Visual Analog Scale Score	Month 24 (n =334, 341, 352)	73.95 units on a scale	Standard Deviation 18.85
Placebo	EuroQoL-5D Visual Analog Scale Score	Baseline (n =480, 479, 484)	67.86 units on a scale	Standard Deviation 19.36
Placebo	EuroQoL-5D Visual Analog Scale Score	Month 24 (n =334, 341, 352)	72.36 units on a scale	Standard Deviation 19.36
Placebo	EuroQoL-5D Visual Analog Scale Score	Month 12 (n =369, 381, 399)	70.58 units on a scale	Standard Deviation 19.91

Secondary

Number of Participants Applicable for Virtual Joint Replacement

A virtual joint replacement candidate was defined as a participant whose last two WOMAC pain subscale scores (overall score range of 0 \[minimum\] to 20 \[maximum\], higher scores indicating more pain) were at least 8, last two WOMAC physical function subscale scores (overall score range of 0 \[minimum\] to 68 \[maximum\], higher scores indicating worse physical function) were at least 28 and was a joint space narrowing progressor (a participant with a decrease in JSW that was greater in magnitude than the smallest detectable difference =0.199 mm).

Time frame: Month 24

Population: FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants Applicable for Virtual Joint Replacement	28 participants
SD-0610 200 mg	Number of Participants Applicable for Virtual Joint Replacement	34 participants
Placebo	Number of Participants Applicable for Virtual Joint Replacement	28 participants

Comparison: Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.88195% CI: [0.602, 1.806]Regression, Logistic

Comparison: Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.52595% CI: [0.701, 2.009]Regression, Logistic

Secondary

Number of Participants With Decrease in Total Analgesic Medication Use

Decrease in total analgesic medication use for OA in the study knee was a comparison back to baseline of a decreased and irregular use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.

Time frame: Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With Decrease in Total Analgesic Medication Use	Month 12 (n =372, 395, 408)	29 participants
SD-0610 50 Milligram (mg)	Number of Participants With Decrease in Total Analgesic Medication Use	Month 24 (n =344, 353, 354)	29 participants
SD-0610 200 mg	Number of Participants With Decrease in Total Analgesic Medication Use	Month 12 (n =372, 395, 408)	38 participants
SD-0610 200 mg	Number of Participants With Decrease in Total Analgesic Medication Use	Month 24 (n =344, 353, 354)	38 participants
Placebo	Number of Participants With Decrease in Total Analgesic Medication Use	Month 12 (n =372, 395, 408)	43 participants
Placebo	Number of Participants With Decrease in Total Analgesic Medication Use	Month 24 (n =344, 353, 354)	47 participants

Comparison: Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.16895% CI: [0.428, 1.16]Regression, Logistic

Comparison: Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.63495% CI: [0.56, 1.423]Regression, Logistic

Comparison: Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.03295% CI: [0.356, 0.955]Regression, Logistic

Comparison: Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.27695% CI: [0.489, 1.227]Regression, Logistic

Secondary

Number of Participants With EuroQo-5D Pain and Discomfort Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D pain and discomfort domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no pain and discomfort), 2 =moderate health (moderate pain and discomfort) and 3 =worst health state (extreme pain and discomfort). Higher scores indicated worse health condition. Participants with EQ-5D pain and discomfort domain score were reported in this measure.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: None (n =371, 382, 399)	91 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: Extreme (n =334, 341, 352)	16 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: Extreme (n =371, 382, 399)	21 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: Moderate (n =371, 382, 399)	259 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: None (n =481, 481, 485)	42 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: Moderate (n =334, 341, 352)	226 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: Extreme (n =481, 481, 485)	56 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: Moderate (n =481, 481, 485)	383 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: None (n =334, 341, 352)	92 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: Moderate (n =371, 382, 399)	280 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: None (n =481, 481, 485)	48 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: Moderate (n =481, 481, 485)	391 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: Extreme (n =481, 481, 485)	42 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: None (n =371, 382, 399)	89 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: Extreme (n =371, 382, 399)	13 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: None (n =334, 341, 352)	89 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: Moderate (n =334, 341, 352)	232 participants
SD-0610 200 mg	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: Extreme (n =334, 341, 352)	20 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: Extreme (n =481, 481, 485)	44 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: None (n =481, 481, 485)	38 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: None (n =334, 341, 352)	98 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Baseline: Moderate (n =481, 481, 485)	403 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: Extreme (n =334, 341, 352)	14 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: Moderate (n =371, 382, 399)	293 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: None (n =371, 382, 399)	82 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 24: Moderate (n =334, 341, 352)	240 participants
Placebo	Number of Participants With EuroQo-5D Pain and Discomfort Domain Score	Month 12: Extreme (n =371, 382, 399)	24 participants

Secondary

Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. EQ-5D anxiety and depression domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (not anxious, depressed), 2 =moderate health (moderately anxious, depressed) and 3 =worst health (extremely anxious, depressed). Higher scores indicating worse health condition. Participants with EQ-5D anxiety and depression domain score were reported in this measure.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 12: None (n =371, 382, 399)	251 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: Extreme (n =334, 341, 352)	6 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month12: Extreme (n =371, 382, 399)	9 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 12: Moderate (n =371, 382, 399)	111 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: None (n =481, 481, 485)	297 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: Moderate (n =334, 341, 352)	93 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: Extreme (n =481, 481, 485)	18 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: Moderate (n =481, 481, 485)	166 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: None (n =334, 341, 352)	235 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 12: Moderate (n =371, 382, 399)	116 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: None (n =481, 481, 485)	306 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: Moderate (n =481, 481, 485)	164 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: Extreme (n =481, 481, 485)	11 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 12: None (n =371, 382, 399)	256 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month12: Extreme (n =371, 382, 399)	10 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: None (n =334, 341, 352)	244 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: Moderate (n =334, 341, 352)	89 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: Extreme (n =334, 341, 352)	8 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: Extreme (n =481, 481, 485)	14 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: None (n =481, 481, 485)	303 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: None (n =334, 341, 352)	237 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Baseline: Moderate (n =481, 481, 485)	168 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: Extreme (n =334, 341, 352)	6 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 12: Moderate (n =371, 382, 399)	127 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 12: None (n =371, 382, 399)	261 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month 24: Moderate (n =334, 341, 352)	109 participants
Placebo	Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score	Month12: Extreme (n =371, 382, 399)	11 participants

Secondary

Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D mobility domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problem), 2 =moderate health (some problems) and 3 =worst health (confined to bed). Higher scores indicating worse health condition. Participants with EQ-5D mobility domain score were reported in this measure.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: No problem (n =371, 382, 399)	174 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: Confined to bed (n =334, 341, 353)	2 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: Confined to bed (n =371, 382, 399)	0 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: Some problems (n =371, 382, 399)	197 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: No problem (n =481, 481, 485)	132 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: Some problems (n =334, 341, 353)	165 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: Confined to bed (n =481, 481, 485)	1 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: Some problems (n =481, 481, 485)	348 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: No problem (n =334, 341, 353)	167 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: Some problems (n =371, 382, 399)	196 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: No problem (n =481, 481, 485)	135 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: Some problems (n =481, 481, 485)	345 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: Confined to bed (n =481, 481, 485)	1 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: No problem (n =371, 382, 399)	186 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: Confined to bed (n =371, 382, 399)	0 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: No problem (n =334, 341, 353)	161 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: Some problems (n =334, 341, 353)	180 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: Confined to bed (n =334, 341, 353)	0 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: Confined to bed (n =481, 481, 485)	0 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: No problem (n =481, 481, 485)	163 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: No problem (n =334, 341, 353)	178 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Baseline: Some problems (n =481, 481, 485)	322 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: Confined to bed (n =334, 341, 353)	0 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: Some problems (n =371, 382, 399)	221 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: No problem (n =371, 382, 399)	178 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 24: Some problems (n =334, 341, 353)	175 participants
Placebo	Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score	Month 12: Confined to bed (n =371, 382, 399)	0 participants

Secondary

Number of Participants With EuroQoL-5D Self-Care Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D self-care domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems with self-care), 2 =moderate health (some problems) and 3 =worst health (unable to wash or dress). Higher scores indicating worse health condition. Participants with EQ-5D self-care domain score were reported in this measure.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: No problem (n =371, 382, 399)	305 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: Unable to wash/dress (n =334, 341, 352)	0 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: Unable to wash/dress (n =371, 382, 399)	0 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: Some problems (n =371, 382, 399)	66 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: No problem (n =480, 481, 485)	383 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: Some problems (n =334, 341, 352)	54 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: Unable to wash/dress (n =480, 481, 485)	5 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: Some problems (n =480, 481, 485)	92 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: No problem (n =334, 341, 352)	280 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: Some problems (n =371, 382, 399)	51 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: No problem (n =480, 481, 485)	387 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: Some problems (n =480, 481, 485)	93 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: Unable to wash/dress (n =480, 481, 485)	1 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: No problem (n =371, 382, 399)	327 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: Unable to wash/dress (n =371, 382, 399)	4 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: No problem (n =334, 341, 352)	286 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: Some problems (n =334, 341, 352)	55 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: Unable to wash/dress (n =334, 341, 352)	0 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: Unable to wash/dress (n =480, 481, 485)	2 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: No problem (n =480, 481, 485)	386 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: No problem (n =334, 341, 352)	299 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Baseline: Some problems (n =480, 481, 485)	97 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: Unable to wash/dress (n =334, 341, 352)	2 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: Some problems (n =371, 382, 399)	67 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: No problem (n =371, 382, 399)	331 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 24: Some problems (n =334, 341, 352)	51 participants
Placebo	Number of Participants With EuroQoL-5D Self-Care Domain Score	Month 12: Unable to wash/dress (n =371, 382, 399)	1 participants

Secondary

Number of Participants With EuroQoL-5D Usual Activity Domain Score

EQ-5D: participant rated questionnaire to assess health-related quality of life. Health state profile component assessed level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, anxiety and depression. EQ-5D usual activity domain score scale ranged from 1 (minimum) to 3 (maximum), where 1 =better health (no problems), 2 =moderate health (some problems) and 3 =worst health state (unable to perform usual activities). Higher scores indicating worse health condition. Participants with EQ-5D usual activity domain score were reported in this measure.

Time frame: Baseline, Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: No problem (n =371, 382, 399)	192 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: Unable to do activities(n =334,340,352)	7 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: Unable to do activities(n =371,382,399)	3 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: Some problems (n =371, 382, 399)	176 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: No problem (n =481, 481, 485)	186 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: Some problems (n =334, 340, 352)	140 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: Unable to do activities(n=481,481,485)	10 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: Some problems (n =481, 481, 485)	285 participants
SD-0610 50 Milligram (mg)	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: No problem (n =334, 340, 352)	187 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: Some problems (n =371, 382, 399)	180 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: No problem (n =481, 481, 485)	185 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: Some problems (n =481, 481, 485)	291 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: Unable to do activities(n=481,481,485)	5 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: No problem (n =371, 382, 399)	201 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: Unable to do activities(n =371,382,399)	1 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: No problem (n =334, 340, 352)	186 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: Some problems (n =334, 340, 352)	151 participants
SD-0610 200 mg	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: Unable to do activities(n =334,340,352)	3 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: Unable to do activities(n=481,481,485)	6 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: No problem (n =481, 481, 485)	190 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: No problem (n =334, 340, 352)	205 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Baseline: Some problems (n =481, 481, 485)	289 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: Unable to do activities(n =334,340,352)	3 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: Some problems (n =371, 382, 399)	204 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: No problem (n =371, 382, 399)	193 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 24: Some problems (n =334, 340, 352)	144 participants
Placebo	Number of Participants With EuroQoL-5D Usual Activity Domain Score	Month 12: Unable to do activities(n =371,382,399)	2 participants

Secondary

Number of Participants With Increase in Total Analgesic Medication Use

Increase in total analgesic medication use for OA in the study knee was a comparison back to baseline of an increased and sustained use of standard background and/or rescue medication for more than 28 days as measured at the Month 12 and 24 visits. Only medications for OA knee pain were considered.

Time frame: Month 12, 24

Population: FAS included all participants randomized to the study. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With Increase in Total Analgesic Medication Use	Month 12 (n =372, 395, 408)	21 participants
SD-0610 50 Milligram (mg)	Number of Participants With Increase in Total Analgesic Medication Use	Month 24 (n =344, 353, 354)	24 participants
SD-0610 200 mg	Number of Participants With Increase in Total Analgesic Medication Use	Month 12 (n =372, 395, 408)	29 participants
SD-0610 200 mg	Number of Participants With Increase in Total Analgesic Medication Use	Month 24 (n =344, 353, 354)	34 participants
Placebo	Number of Participants With Increase in Total Analgesic Medication Use	Month 12 (n =372, 395, 408)	24 participants
Placebo	Number of Participants With Increase in Total Analgesic Medication Use	Month 24 (n =344, 353, 354)	30 participants

Comparison: Month 12; Odds ratio (OR), 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.87595% CI: [0.516, 1.756]Regression, Logistic

Comparison: Month 12; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.40695% CI: [0.721, 2.247]Regression, Logistic

Comparison: Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.40695% CI: [0.448, 1.384]Regression, Logistic

Comparison: Month 24; Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.59195% CI: [0.685, 1.942]Regression, Logistic

Secondary

Number of Participants With Joint Space Narrowing Progression

JSN progressor was defined as a participant with a decrease in joint space width that was greater in magnitude than the smallest detectable difference (0.199 mm).

Time frame: Month 24

Population: FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With Joint Space Narrowing Progression	136 participants
SD-0610 200 mg	Number of Participants With Joint Space Narrowing Progression	153 participants
Placebo	Number of Participants With Joint Space Narrowing Progression	165 participants

Comparison: Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.04795% CI: [0.557, 0.997]Regression, Logistic

Comparison: Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, age and body mass index as covariates.p-value: 0.31795% CI: [0.65, 1.15]Regression, Logistic

Secondary

Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

The OMERACT-OARSI responder index was used to determine whether participants may be considered responders to treatment. An OMERACT-OARSI responder was a participant who had a better response on the WOMAC pain subscale score, a better response on the WOMAC physical function subscale score or improvement on at least two of the three domains: WOMAC pain subscale score (overall score range of 0 \[minimum\] to 20 \[maximum\], higher scores indicating more pain), WOMAC physical function subscale score (overall score range of 0 \[minimum\] to 68 \[maximum\], higher scores indicating worse physical function) and patient global assessment of arthritic condition score (overall score range of 1 \[minimum\] to 5 \[maximum\], higher scores indicating worse condition). Number of participants who were OMERACT-OARSI responder were reported in this measure.

Time frame: Month 24

Population: FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SD-0610 50 Milligram (mg)	Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	222 participants
SD-0610 200 mg	Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	226 participants
Placebo	Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index	219 participants

Comparison: Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.p-value: 0.8195% CI: [0.797, 1.337]Regression, Logistic

Comparison: Odds ratio, 95 percent CI and P-values were obtained from a logistic regression model, with treatment group, (collapsed) KLG, geographic region, and gender as factors, baseline JSW, age and body mass index as covariates.p-value: 0.6295% CI: [0.824, 1.383]Regression, Logistic

Secondary

Patient Global Impression of Change Score

Patient global impression of change was a participant-rated instrument that measured change in participant's overall status on a 7-point scale ranging from: 1 =very much improved, 2 =much improved, 3 =minimally improved, 4 =no change, 5 =minimally worse, 6 =much worse and 7 =very much worse. Higher scores indicating worse condition.

Time frame: Month 24

Population: FAS included all participants randomized to the study. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Patient Global Impression of Change Score	2.97 units on a scale	Standard Deviation 1.26
SD-0610 200 mg	Patient Global Impression of Change Score	3.02 units on a scale	Standard Deviation 1.34
Placebo	Patient Global Impression of Change Score	3.00 units on a scale	Standard Deviation 1.35

Comparison: LS Mean, 95 percent CI and P-values were obtained from an analysis of covariance (ANCOVA) model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.p-value: 0.70995% CI: [-0.21, 0.14]ANCOVA

Comparison: LS-Mean, 95 percent CI and P-values were obtained from an ANCOVA model, with treatment group, (collapsed) KLG, geographic region, and gender as factors and age and body mass index as covariates.p-value: 0.79895% CI: [-0.15, 0.2]ANCOVA

Other Pre-specified

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

BP was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.

Time frame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96

Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	-0.69 mmHg	Standard Deviation 7.56
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	0.02 mmHg	Standard Deviation 7.46
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n= 346, 366, 362)	-0.39 mmHg	Standard Deviation 8.03
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 400, 410)	-0.16 mmHg	Standard Deviation 8.28
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =385, 415, 418)	-0.21 mmHg	Standard Deviation 7.86
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	76.46 mmHg	Standard Deviation 7.68
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 467, 465)	0.07 mmHg	Standard Deviation 7.04
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 462)	0.13 mmHg	Standard Deviation 6.63
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	-0.49 mmHg	Standard Deviation 8.06
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	0.02 mmHg	Standard Deviation 7.29
SD-0610 50 Milligram (mg)	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	-0.21 mmHg	Standard Deviation 8.02
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =385, 415, 418)	-0.31 mmHg	Standard Deviation 7.58
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	77.06 mmHg	Standard Deviation 7.53
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 462)	0.58 mmHg	Standard Deviation 6.61
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 467, 465)	0.78 mmHg	Standard Deviation 7.33
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	1.21 mmHg	Standard Deviation 7.56
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	0.53 mmHg	Standard Deviation 7.8
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 400, 410)	-0.19 mmHg	Standard Deviation 7.99
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	0.10 mmHg	Standard Deviation 7.91
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	0.30 mmHg	Standard Deviation 8.81
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n= 346, 366, 362)	-0.28 mmHg	Standard Deviation 7.93
SD-0610 200 mg	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	-0.20 mmHg	Standard Deviation 8.82
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n= 346, 366, 362)	-0.78 mmHg	Standard Deviation 8.6
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	-0.84 mmHg	Standard Deviation 8.32
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 467, 465)	-0.41 mmHg	Standard Deviation 7.11
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	76.85 mmHg	Standard Deviation 7.71
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	-0.77 mmHg	Standard Deviation 8.14
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 462)	0.37 mmHg	Standard Deviation 7.07
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =385, 415, 418)	-1.18 mmHg	Standard Deviation 7.86
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	-0.33 mmHg	Standard Deviation 7.52
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	-0.70 mmHg	Standard Deviation 8.47
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 400, 410)	-0.07 mmHg	Standard Deviation 7.67
Placebo	Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	0.05 mmHg	Standard Deviation 7.58

Comparison: Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.23895% CI: [-1.31, 0.32]Mixed Models Analysis

Comparison: Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.81595% CI: [-0.72, 0.91]Mixed Models Analysis

Comparison: Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.50895% CI: [-0.54, 1.1]Mixed Models Analysis

Comparison: Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.00495% CI: [0.38, 2.02]Mixed Models Analysis

Comparison: Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.68395% CI: [-1.07, 0.7]Mixed Models Analysis

Comparison: Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.00795% CI: [0.33, 2.09]Mixed Models Analysis

Comparison: Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.68795% CI: [-0.71, 1.07]Mixed Models Analysis

Comparison: Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.0595% CI: [0, 1.78]Mixed Models Analysis

Comparison: Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.21595% CI: [-0.35, 1.54]Mixed Models Analysis

Comparison: Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.04295% CI: [0.03, 1.89]Mixed Models Analysis

Comparison: Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.40195% CI: [-1.41, 0.56]Mixed Models Analysis

Comparison: Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.9895% CI: [-0.96, 0.99]Mixed Models Analysis

Comparison: Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.63295% CI: [-1.25, 0.76]Mixed Models Analysis

Comparison: Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.03295% CI: [0.09, 2.07]Mixed Models Analysis

Comparison: Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.66895% CI: [-1.29, 0.83]Mixed Models Analysis

Comparison: Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.03895% CI: [0.06, 2.16]Mixed Models Analysis

Comparison: Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.86895% CI: [-1.13, 0.95]Mixed Models Analysis

Comparison: Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.25795% CI: [-0.43, 1.62]Mixed Models Analysis

Comparison: Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.89595% CI: [-1, 1.15]Mixed Models Analysis

Comparison: Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.26895% CI: [-0.46, 1.67]Mixed Models Analysis

Other Pre-specified

Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

Time frame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96

Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	-0.42 beats per minute (bpm)	Standard Deviation 8.37
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	0.45 beats per minute (bpm)	Standard Deviation 8.3
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n =346, 366, 362)	-0.31 beats per minute (bpm)	Standard Deviation 8.65
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 399, 410)	-0.82 beats per minute (bpm)	Standard Deviation 8.45
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =384, 415, 418)	-0.08 beats per minute (bpm)	Standard Deviation 8.58
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	69.74 beats per minute (bpm)	Standard Deviation 9.11
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 466, 465)	0.24 beats per minute (bpm)	Standard Deviation 7.53
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 461)	0.58 beats per minute (bpm)	Standard Deviation 7.35
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	-0.95 beats per minute (bpm)	Standard Deviation 8.75
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	0.13 beats per minute (bpm)	Standard Deviation 7.7
SD-0610 50 Milligram (mg)	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	-1.09 beats per minute (bpm)	Standard Deviation 8.91
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =384, 415, 418)	-0.07 beats per minute (bpm)	Standard Deviation 7.8
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	69.12 beats per minute (bpm)	Standard Deviation 8.72
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 461)	-0.29 beats per minute (bpm)	Standard Deviation 6.68
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 466, 465)	0.23 beats per minute (bpm)	Standard Deviation 7.46
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	-0.17 beats per minute (bpm)	Standard Deviation 7.61
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	-0.42 beats per minute (bpm)	Standard Deviation 7.46
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 399, 410)	-1.37 beats per minute (bpm)	Standard Deviation 8.23
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	0.04 beats per minute (bpm)	Standard Deviation 7.56
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	-0.99 beats per minute (bpm)	Standard Deviation 7.91
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n =346, 366, 362)	-0.15 beats per minute (bpm)	Standard Deviation 7.88
SD-0610 200 mg	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	-0.61 beats per minute (bpm)	Standard Deviation 8.53
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n =346, 366, 362)	0.57 beats per minute (bpm)	Standard Deviation 8.64
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	0.47 beats per minute (bpm)	Standard Deviation 8.9
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 466, 465)	0.78 beats per minute (bpm)	Standard Deviation 7.77
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	69.34 beats per minute (bpm)	Standard Deviation 8.26
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	0.85 beats per minute (bpm)	Standard Deviation 9.56
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 461)	0.71 beats per minute (bpm)	Standard Deviation 7.55
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =384, 415, 418)	0.76 beats per minute (bpm)	Standard Deviation 8.41
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	0.06 beats per minute (bpm)	Standard Deviation 8.37
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	0.36 beats per minute (bpm)	Standard Deviation 8.61
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 399, 410)	-0.11 beats per minute (bpm)	Standard Deviation 8.59
Placebo	Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	0.05 beats per minute (bpm)	Standard Deviation 8.24

Comparison: Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.90895% CI: [-0.92, 0.82]Mixed Models Analysis

Comparison: Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.00895% CI: [-2.05, -0.31]Mixed Models Analysis

Comparison: Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.4495% CI: [-1.25, 0.54]Mixed Models Analysis

Comparison: Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.1495% CI: [-1.57, 0.22]Mixed Models Analysis

Comparison: Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.47495% CI: [-0.58, 1.24]Mixed Models Analysis

Comparison: Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.37695% CI: [-1.32, 0.5]Mixed Models Analysis

Comparison: Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.18695% CI: [-0.32, 1.64]Mixed Models Analysis

Comparison: Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.18595% CI: [-1.63, 0.32]Mixed Models Analysis

Comparison: Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.33495% CI: [-1.53, 0.52]Mixed Models Analysis

Comparison: Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.05595% CI: [-2, 0.02]Mixed Models Analysis

Comparison: Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.53995% CI: [-1.38, 0.72]Mixed Models Analysis

Comparison: Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.01895% CI: [-2.3, -0.22]Mixed Models Analysis

Comparison: Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.36595% CI: [-1.52, 0.56]Mixed Models Analysis

Comparison: Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.40395% CI: [-1.47, 0.59]Mixed Models Analysis

Comparison: Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.0295% CI: [-2.43, -0.21]Mixed Models Analysis

Comparison: Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: <0.00195% CI: [-2.98, -0.77]Mixed Models Analysis

Comparison: Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.26995% CI: [-1.66, 0.46]Mixed Models Analysis

Comparison: Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.10495% CI: [-1.92, 0.18]Mixed Models Analysis

Comparison: Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.03895% CI: [-2.3, -0.06]Mixed Models Analysis

Comparison: Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.04195% CI: [-2.28, -0.05]Mixed Models Analysis

Other Pre-specified

Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

Blood pressure (BP) was measured by sphygmomanometer while participant was in supine position. Conditions were kept constant from visit to visit including observer, participant's same arm, cuff size, supine position, location, temperature, noise level. The same size BP cuff which was properly sized and calibrated, was used to measure BP each time.

Time frame: Baseline, Week 2, 4, 12, 24, 36, 48, 60, 72, 84, 96

Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (MEAN)	Dispersion
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	-1.02 millimeters of mercury (mmHg)	Standard Deviation 12.38
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	-0.47 millimeters of mercury (mmHg)	Standard Deviation 12.07
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n =346, 366, 362)	-1.43 millimeters of mercury (mmHg)	Standard Deviation 13.45
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 400, 410)	-0.83 millimeters of mercury (mmHg)	Standard Deviation 12.36
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =385, 415, 418)	-0.11 millimeters of mercury (mmHg)	Standard Deviation 11.98
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	127.04 millimeters of mercury (mmHg)	Standard Deviation 12.42
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 467, 465)	-1.08 millimeters of mercury (mmHg)	Standard Deviation 11.37
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 462)	-0.06 millimeters of mercury (mmHg)	Standard Deviation 9.76
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	-0.82 millimeters of mercury (mmHg)	Standard Deviation 12.94
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	-0.11 millimeters of mercury (mmHg)	Standard Deviation 11.59
SD-0610 50 Milligram (mg)	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	-0.55 millimeters of mercury (mmHg)	Standard Deviation 12.84
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =385, 415, 418)	-0.80 millimeters of mercury (mmHg)	Standard Deviation 12.02
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	127.45 millimeters of mercury (mmHg)	Standard Deviation 12.18
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 462)	0.82 millimeters of mercury (mmHg)	Standard Deviation 10.66
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 467, 465)	0.99 millimeters of mercury (mmHg)	Standard Deviation 11.12
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	1.74 millimeters of mercury (mmHg)	Standard Deviation 12.09
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	0.97 millimeters of mercury (mmHg)	Standard Deviation 12.14
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 400, 410)	-0.22 millimeters of mercury (mmHg)	Standard Deviation 11.39
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	0.33 millimeters of mercury (mmHg)	Standard Deviation 12.02
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	-0.15 millimeters of mercury (mmHg)	Standard Deviation 13
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n =346, 366, 362)	-0.77 millimeters of mercury (mmHg)	Standard Deviation 12.98
SD-0610 200 mg	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	0.02 millimeters of mercury (mmHg)	Standard Deviation 12.52
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 84 (n =346, 366, 362)	-1.15 millimeters of mercury (mmHg)	Standard Deviation 13.08
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 60 (n =360, 377, 384)	-1.36 millimeters of mercury (mmHg)	Standard Deviation 12.24
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 4 (n =467, 467, 465)	-0.94 millimeters of mercury (mmHg)	Standard Deviation 10.73
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Baseline (n =482, 485, 485)	127.45 millimeters of mercury (mmHg)	Standard Deviation 12.32
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 72 (n =357, 374, 370)	-0.20 millimeters of mercury (mmHg)	Standard Deviation 13
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 2 (n =459, 466, 462)	-0.01 millimeters of mercury (mmHg)	Standard Deviation 10.71
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 36 (n =385, 415, 418)	-1.58 millimeters of mercury (mmHg)	Standard Deviation 12.99
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 24 (n =425, 432, 439)	-0.73 millimeters of mercury (mmHg)	Standard Deviation 11.46
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 96 (n =344, 353, 356)	-0.71 millimeters of mercury (mmHg)	Standard Deviation 12.79
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 48 (n =377, 400, 410)	-0.28 millimeters of mercury (mmHg)	Standard Deviation 12.01
Placebo	Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96	Change at Week 12 (n =450, 455, 461)	-0.76 millimeters of mercury (mmHg)	Standard Deviation 12.33

Comparison: Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.66895% CI: [-1.5, 0.96]Mixed Models Analysis

Comparison: Week 2; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.32695% CI: [-0.61, 1.85]Mixed Models Analysis

Comparison: Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.67995% CI: [-1.56, 1.01]Mixed Models Analysis

Comparison: Week 4; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.00595% CI: [0.57, 3.14]Mixed Models Analysis

Comparison: Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.39995% CI: [-0.8, 2.01]Mixed Models Analysis

Comparison: Week 12; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: <0.00195% CI: [1.12, 3.92]Mixed Models Analysis

Comparison: Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.66895% CI: [-1.08, 1.68]Mixed Models Analysis

Comparison: Week 24; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.01295% CI: [0.39, 3.13]Mixed Models Analysis

Comparison: Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group x visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.10995% CI: [-0.27, 2.67]Mixed Models Analysis

Comparison: Week 36; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.16395% CI: [-0.42, 2.48]Mixed Models Analysis

Comparison: Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.42495% CI: [-2.02, 0.85]Mixed Models Analysis

Comparison: Week 48; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.63595% CI: [-1.07, 1.76]Mixed Models Analysis

Comparison: Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.85595% CI: [-1.34, 1.61]Mixed Models Analysis

Comparison: Week 60; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.01395% CI: [0.38, 3.3]Mixed Models Analysis

Comparison: Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.29295% CI: [-2.44, 0.73]Mixed Models Analysis

Comparison: Week 72; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.89795% CI: [-1.47, 1.68]Mixed Models Analysis

Comparison: Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.3995% CI: [-2.36, 0.92]Mixed Models Analysis

Comparison: Week 84; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.65995% CI: [-1.26, 1.99]Mixed Models Analysis

Comparison: Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.84795% CI: [-1.73, 1.42]Mixed Models Analysis

Comparison: Week 96; LS-Mean, 95 percent CI and P-values were obtained from a discrete time MMRM model with fixed effects for treatment group, visit, a treatment group\*visit interaction, (collapsed) KLG, a (collapsed) KLG\*visit interaction, baseline value, geographic region, gender, age and body mass index with an unstructured covariance matrix.p-value: 0.33395% CI: [-0.79, 2.34]Mixed Models Analysis

Other Pre-specified

Number of Participants With Electrocardiogram (ECG) Abnormalities

Atrial (enlargement, fibrillation, premature beat), axis deviation, atrioventricular (accelerated conduction, first/second degree block), left anterior and posterior hemiblock, left atrial hypertrophy, left and right (complete/incomplete bundle branch block, ventricular hypertrophy), QRS (high/low voltage, nonspecific, prolongation greater than \[\>\]140 milliseconds \[msec\]), junctional/paced rhythm, intraventricular conduction delay (\>120 msec), early repolarization, ventricular premature contraction and beat, prolonged QTC, sinus (arrhythmia, bradycardia/tachycardia), supraventricular extra systole and premature beat, short PR syndrome. Abnormal Q-wave (\>=30 msec), P-wave left/right atrial abnormality, T-wave flattened/inverted abnormality, U-wave abnormality, ST-T indeterminate abnormality, ST-T nonspecific changes, ST-T changes compatible with ischemia and pericarditis. ECG findings were judged by investigators for qualitative evaluation of abnormalities.

Time frame: Baseline, Month 3, 6, 12, 18, 24

Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'n' signifies participants evaluable for this outcome measure at given time points for each group.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 18 (n =351, 366, 362)	2 participants
SD-0610 50 Milligram (mg)	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 12 (n =373 , 397, 403)	4 participants
SD-0610 50 Milligram (mg)	Number of Participants With Electrocardiogram (ECG) Abnormalities	Baseline (n =481, 484, 485)	0 participants
SD-0610 50 Milligram (mg)	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 6 (n =414, 427, 427)	3 participants
SD-0610 50 Milligram (mg)	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 24 (n =338, 344, 351)	3 participants
SD-0610 200 mg	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 12 (n =373 , 397, 403)	1 participants
SD-0610 200 mg	Number of Participants With Electrocardiogram (ECG) Abnormalities	Baseline (n =481, 484, 485)	0 participants
SD-0610 200 mg	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 6 (n =414, 427, 427)	0 participants
SD-0610 200 mg	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 18 (n =351, 366, 362)	2 participants
SD-0610 200 mg	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 24 (n =338, 344, 351)	1 participants
Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 24 (n =338, 344, 351)	6 participants
Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 18 (n =351, 366, 362)	6 participants
Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities	Baseline (n =481, 484, 485)	1 participants
Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 12 (n =373 , 397, 403)	2 participants
Placebo	Number of Participants With Electrocardiogram (ECG) Abnormalities	Month 6 (n =414, 427, 427)	1 participants

Other Pre-specified

Number of Participants With Laboratory Test Abnormalities

Criteria for laboratory abnormalities: Hemoglobin (Hgb), hematocrit (hct), red blood cell(RBC) count: less than(\<)0.8\*lower limit of normal(LLN), platelet: \<0.5\*LLN or greater than (\>)1.75\*upper limit of normal (ULN), white blood cell (WBC): \<0.6\*LLN or \>1.5\*ULN, lymphocyte, neutrophil:\<0.8\*LLN or \>1.2\*ULN, basophil, eosinophil, monocyte:\>1.2\*ULN; total bilirubin \>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, gammaglutamyl transferase, alkaline phosphatase:\> 3.0\*ULN, total protein, albumin: \<0.8\*LLN or \>1.2\*ULN; blood urea nitrogen, creatinine:\>1.3\*ULN, uric acid \>1.2\*ULN; sodium \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, calcium, magnesium, bicarbonate: \<0.9\*LLN or \>1.1\*ULN, phosphate \<0.8\*LLN or \>1.2\*ULN; glucose \<0.6\*LLN or \>1.5\*ULN, lipase \>1.5\*ULN; urine (specific gravity \<1.003 or \>1.030, pH \<4.5 or \>8, glucose, ketones, protein, blood/Hgb greater than or equal to \[\>=\]1); pancreatic amylase \>1.5\*ULN.

Time frame: Baseline up to Week 111

Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication. Here, 'N' signifies participants evaluable for this outcome measure.

Arm	Measure	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With Laboratory Test Abnormalities	289 participants
SD-0610 200 mg	Number of Participants With Laboratory Test Abnormalities	297 participants
Placebo	Number of Participants With Laboratory Test Abnormalities	288 participants

Other Pre-specified

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 7-10 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. Adverse events included both serious and non-serious adverse events.

Time frame: Baseline up to 7-10 days after last dose of study drug (Week 111)

Population: The safety analysis set included all participants in the FAS who received at least 1 dose of the randomized study medication.

Arm	Measure	Group	Value (NUMBER)
SD-0610 50 Milligram (mg)	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse events	371 participants
SD-0610 50 Milligram (mg)	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Serious adverse events	43 participants
SD-0610 200 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse events	381 participants
SD-0610 200 mg	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Serious adverse events	61 participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Adverse events	364 participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Serious adverse events	49 participants

A Long-Term, Placebo-Controlled X-Ray Study Investigating the Safety and Efficacy of SD-6010 in Subjects With Osteoarthritis of the Knee

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Rate of Progression of Joint Space Narrowing

Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Equal to (=) 3

Rate of Progression of Joint Space Narrowing in Participants With Kellgren and Lawrence Grade Less Than or Equal to (<=) 2

Change From Baseline in Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS) Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Constant Pain Subscale Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Intermittent Pain Subscale Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Osteoarthritis Pain Assessment Tool-Knee Joint Total Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Osteoarthritis Research Society International (OARSI) Knee Function Survey Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Pain After a 50-foot Walk Using Pain Visual Analog Scale Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Patient Assessment of Arthritic Pain Visual Analog Scale (VAS) Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Patient Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Physician's Global Assessment of Arthritic Condition Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Short Form-36 Bodily Pain Domain Score at Month 12 and 24

Change From Baseline in Short Form-36 General Health Domain Score at Month 12 and 24

Change From Baseline in Short Form-36 Mental Health Component Score at Month 12 and 24

Change From Baseline in Short Form-36 Mental Health Domain Score at Month 12 and 24

Change From Baseline in Short Form-36 Physical Health Component Score at Month 12 and 24

Change From Baseline in Short Form-36 Role-Emotional Domain Score at Month 12 and 24

Change From Baseline in Short Form-36 Role - Physical Domain Score at Month 12 and 24

Change From Baseline in Short Form-36 (SF-36) Physical Functioning Domain Score at Month 12 and 24

Change From Baseline in Short Form-36 Social Functioning Domain Score at Month 12 and 24

Change From Baseline in Short Form-36 Vitality Domain Score at Month 12 and 24

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Stiffness Subscale Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Pain Subscale Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index Physical Function Subscale Score at Month 3, 6, 12, 18 and 24

Change From Baseline in Western Ontario and MacMaster Osteoarthritis Index (WOMAC) Composite Index Score at Month 3, 6, 12, 18 and 24

EuroQoL-5D Visual Analog Scale Score

Number of Participants Applicable for Virtual Joint Replacement

Number of Participants With Decrease in Total Analgesic Medication Use

Number of Participants With EuroQo-5D Pain and Discomfort Domain Score

Number of Participants With EuroQoL-5D Anxiety and Depression Domain Score

Number of Participants With EuroQoL-5D (EQ-5D) Mobility Domain Score

Number of Participants With EuroQoL-5D Self-Care Domain Score

Number of Participants With EuroQoL-5D Usual Activity Domain Score

Number of Participants With Increase in Total Analgesic Medication Use

Number of Participants With Joint Space Narrowing Progression

Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

Patient Global Impression of Change Score

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

Change From Baseline in Heart Rate at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

Change From Baseline in Systolic Blood Pressure (SBP) at Week 2, 4, 12, 24, 36, 48, 60, 72, 84 and 96

Number of Participants With Electrocardiogram (ECG) Abnormalities

Number of Participants With Laboratory Test Abnormalities

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)