WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

Modified ITT (mITT): All participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here "Overall number of participants analyzed (N)" signifies the participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here 'N' signifies the participants evaluable for this outcome measure.

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 [minimum affected] to 5 [maximum affected], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values.

A participant was considered as an OMERACT-OARSI responder: if the improvement from baseline to week of interest was greater than or equal to (>=) 50 percent and >=2 units in WOMAC pain or physical function subscale; if improvement from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: a) WOMAC pain subscale, b) WOMAC physical function subscale, c) PGA of osteoarthritis. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and PGA of osteoarthritis (score: 1 [minimum affected] to 5 [maximum affected], higher score = worse condition). Percentage of participants who were OMERACT-OARSI responder were reported in this outcome measure.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with at least 30 percent and 50 percent reduction in WOMAC pain subscale were reported in this outcome measure.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.

Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition. Percentage of participants with at least 2 points improvement from baseline in PGA of osteoarthritis at specified weeks were reported.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. Percentage of participants with cumulative reduction (greater than 0 percent [%]; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; = 100 %) in WOMAC pain subscale from Baseline up to Week 16 were reported.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

Participants assessed daily average pain score in the index knee using a scale ranging from 0 (no pain) to 10 (maximum pain), where higher scores indicate more pain. A weekly mean was calculated using the daily average index knee pain scores within each specified study week.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in knee joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate greater stiffness. An overall possible WOMAC stiffness subscale score range is of 0 (minimum stiffness) to 10 (maximum stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in moving the index knee.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [minimum stiffness] to 10 [maximum stiffness], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale assess amount of pain experienced (score: 0 [minimum pain] to 10 [maximum pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [minimum difficulty] to 10 [maximum difficulty], higher score = higher difficulty) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [minimum stiffness] to 10 [maximum stiffness], higher score = higher stiffness). WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores, giving an overall possible WOMAC average score range of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse response.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when walking on a flat surface, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. Participants responded by using a numerical rating scale of 0 (no pain) to 10 (maximum pain) about the amount of pain they experienced when going up or down stairs, where 0= no pain and 10= extreme pain. Higher score indicates more pain.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'N' signifies number of participants evaluable for this outcome measure.

SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. BOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.

SF-36 health survey is a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional and domain 8= mental health. Total score for each of the 8 domains are scaled from 0 (minimum level of functioning) to 100 (maximum level of functioning). These 8 domains are also summarized as 2 summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for each of the 2 summary scores =0 (minimum level of functioning) to 100 (maximum level of functioning). Higher (8 domains and 2 summary) scores indicate a better health related quality of life.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.

Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.

ITT analysis set included all randomized participants who received at least 1 dose of the study drug.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the specified study week were summarized.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. Number of days participants used any of the rescue medication, during the specified week were summarized.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable at specific time points.

In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.

mITT population included all participants who received at least 1 dose of the study drug, except those with concerns about data integrity at 1 of the study centers. LOCF method was used to impute missing values. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.

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 are events between first dose of study drug and up to Week 24 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

ITT analysis set included all randomized participants who received at least 1 dose of the study drug.

Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,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;cholesterol,triglycerides>1.3*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,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).

ITT analysis set included all randomized participants who received at least 1 dose of the study drug. Here, 'N' signifies number of participants evaluable for this outcome measure.

Criteria for potential clinical concern in ECG parameters are: Criterion 1= maximum QTcB interval (Bazett's correction) in range of 450 millisecond (msec) to less than 480 msec, Criterion 2= maximum QTcB interval in range of 480 msec to less than 500 msec, Criterion 3= maximum QTcB interval >= 500 msec; Criterion 4= maximum QTcF interval (Fridericia's correction) in range of 450 msec to less than 480 msec, Criterion 5= maximum QTcF interval in range of 480 msec to less than 500 msec, Criterion 6= maximum QTcF interval >= 500 msec, Criterion 7= maximum QTcB interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 8= maximum QTcB interval increase >=60 msec, Criterion 9= maximum QTcF interval increase from baseline in range of 30 msec to less than 60 msec, Criterion 10= maximum QTcF interval increase >=60 msec.

ITT analysis set included all randomized participants who received at least 1 dose of the study drug. Here, 'Number Analyzed' signifies number of participants evaluable for specific time points.

NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items from both the left and right side, where 24 items scored from 0 (normal function) to 4 (extreme abnormal function), higher score indicates higher abnormality and 13 items scored from 0 (normal function) to 2 (extreme abnormal function), higher score indicates higher abnormality. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicate increased impairment.

ITT analysis set included all randomized participants who received at least 1 dose of the study drug. LOCF method was used to impute missing values.

Participants who developed anti-tanezumab antibodies after treatment were evaluated for the presence of anti-tanezumab neutralizing antibodies in their serum. Number of participants with positive ADA were summarized for reporting groups: tanezumab 5 mg + placebo and tanezumab 10 mg + placebo. Results with titer value >= 4.32 nanogram per milliliter of anti-tanezumab neutralizing antibodies were counted as positive.

Analysis set included all randomized participants who received at least 1 dose of the study drug. This outcome measure was planned not to be analyzed for reporting arms: placebo and naproxen + placebo.

Assessment of the clinical significance of vital sign changes was done per investigator judgment. Changes in vital signs determined to be clinically significant by the investigator were reported as adverse events.

ITT analysis set included all randomized participants who received at least 1 dose of the study drug.