Tanezumab In Osteoarthritis Of The Knee (2)

A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00830063

Enrollment

832

Registered

2009-01-27

Start date

2009-05-05

Completion date

2010-08-31

Last updated

2021-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Osteoarthritis

Keywords

monoclonal antibody, RN624, PF-04383119, nerve growth factor, anti-nerve growth factor, OA, pain

Brief summary

The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.

Interventions

BIOLOGICALtanezumab 10 mg

tanezumab 10 mg one dose at weeks 0 and 8

BIOLOGICALtanezumab 5 mg

tanezumab 5 mg one dose at weeks 0 and 8

DRUGnaproxen

naproxen 1000 mg daily for 16 weeks

OTHERplacebo

placebo to match tanezumab and naproxen dosing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion criteria

* Pregnancy or intent to become pregnant * BMI greater than 39 * other severe pain, significant cardiac, neurologic or cardiac disease

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline (Day 1), Week 16	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.
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 16	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.

Secondary

Measure	Time frame	Description
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	Baseline up to Week 16	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.
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 12, 16	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.
Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline, Week 12, 16	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.
Time to Discontinuation Due to Lack of Efficacy	Baseline up to Week 16	Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Percentage of Participants Who Used Rescue Medication	Week 2, 4, 8, 12, 16	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.
Number of Days Participants Used Rescue Medication	Week 2, 4, 8, 12, 16	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.
Amount of Rescue Medication Taken	Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12	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.
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12	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.
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12	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 Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Weeks 2, 4, 8, 12, 16	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.
Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 2, 4, 8, 12, 16	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.
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2, 4, 8, 12, 16	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.
Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2, 4, 8, 12, 16	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.
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Baseline up to Week 16	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.
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline, Week 2, 4, 8, 12, 16	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.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline, Week 2, 4, 8, 12, 16	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.

Other

Measure	Time frame	Description
Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Baseline, Week 8, 16, 24	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.
Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities	Day 1 (Baseline) up to Week 24	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.
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Day 1 (Baseline) up to Week 24	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.
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Day 1 (Baseline) up to Week 24	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.
Number of Participants With Laboratory Test Abnormalities	Day 1 (Baseline) up to Week 24	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).
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Baseline, Week 2, 4, 8, 12, 16, 24	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo Participants received placebo matched to tanezumab (RN624 or PF-04383119) intravenous (IV) infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily (BID) from Day 1 to Week 16.	208
Tanezumab 5 mg + Placebo Participants received tanezumab (RN624 or PF-04383119) 5 milligram (mg) IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	206
Tanezumab 10 mg + Placebo Participants received tanezumab (RN624 or PF-04383119) 10 mg IV infusion at Day 1 and Week 8, and placebo matched to naproxen tablet orally twice daily from Day 1 to Week 16.	208
Naproxen + Placebo Participants received naproxen 500 mg tablet orally twice daily from Day 1 to Week 16 and placebo matched to tanezumab (RN624 or PF-04383119) IV infusion at Day 1 and Week 8.	206
Total	828

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	7	13	16	13
Overall Study	Death	1	0	0	0
Overall Study	Lack of Efficacy	51	23	25	32
Overall Study	Lost to Follow-up	0	0	3	1
Overall Study	Other	5	5	8	6
Overall Study	Preferred Time Entry in Extension Study	119	139	127	126
Overall Study	Protocol Violation	1	0	3	2
Overall Study	Randomized But Not Treated	0	2	0	2
Overall Study	Withdrawal by Subject	16	10	16	13

Baseline characteristics

Characteristic	Placebo	Tanezumab 5 mg + Placebo	Tanezumab 10 mg + Placebo	Naproxen + Placebo	Total
Age, Continuous	60.9 years STANDARD_DEVIATION 10.1	61.1 years STANDARD_DEVIATION 10.1	61.1 years STANDARD_DEVIATION 10.3	61.4 years STANDARD_DEVIATION 10	61.1 years STANDARD_DEVIATION 10.1
Sex: Female, Male Female	120 Participants	122 Participants	128 Participants	129 Participants	499 Participants
Sex: Female, Male Male	88 Participants	84 Participants	80 Participants	77 Participants	329 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	59 / 208	70 / 206	92 / 208	68 / 206
serious Total, serious adverse events	8 / 208	7 / 206	6 / 208	5 / 206

Outcome results

Primary

Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.41 units on a scale	Standard Deviation 0.61
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-0.53 units on a scale	Standard Deviation 0.83
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-0.87 units on a scale	Standard Deviation 1.02
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.41 units on a scale	Standard Deviation 0.59
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-0.74 units on a scale	Standard Deviation 0.88
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.39 units on a scale	Standard Deviation 0.55
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	3.44 units on a scale	Standard Deviation 0.62
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-0.70 units on a scale	Standard Deviation 0.97

Comparison: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.p-value: <0.00195% CI: [-0.5, -0.16]ANCOVA

Primary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline (Day 1), Week 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.21 units on a scale	Standard Deviation 1.43
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.23 units on a scale	Standard Deviation 2.56
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.55 units on a scale	Standard Deviation 2.84
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.30 units on a scale	Standard Deviation 1.47
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.25 units on a scale	Standard Deviation 1.41
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.27 units on a scale	Standard Deviation 2.81
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.18 units on a scale	Standard Deviation 1.37
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.82 units on a scale	Standard Deviation 2.54

Comparison: Least square (LS) mean was estimated from the corresponding analysis of covariance (ANCOVA) model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95 percent (%) confidence interval (CI) was calculated on LS mean difference.p-value: <0.00195% CI: [-1.76, -0.72]ANCOVA

Primary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.85 units on a scale	Standard Deviation 1.56
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.88 units on a scale	Standard Deviation 2.29
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.18 units on a scale	Standard Deviation 2.64
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.71
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.5
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.91 units on a scale	Standard Deviation 2.59
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.57
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.42 units on a scale	Standard Deviation 2.4

Secondary

Amount of Rescue Medication Taken

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.

Time frame: Week 2, 4, 8, 12, 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Amount of Rescue Medication Taken	Week 8	3320.00 mg	Standard Deviation 5384.01
Placebo	Amount of Rescue Medication Taken	Week 2	3512.50 mg	Standard Deviation 5086.79
Placebo	Amount of Rescue Medication Taken	Week 12	2857.50 mg	Standard Deviation 5617.94
Placebo	Amount of Rescue Medication Taken	Week 4	3492.50 mg	Standard Deviation 5755.81
Placebo	Amount of Rescue Medication Taken	Week 16	2860.00 mg	Standard Deviation 5948.73
Tanezumab 5 mg + Placebo	Amount of Rescue Medication Taken	Week 8	1684.08 mg	Standard Deviation 3506.56
Tanezumab 5 mg + Placebo	Amount of Rescue Medication Taken	Week 4	1773.63 mg	Standard Deviation 3849.64
Tanezumab 5 mg + Placebo	Amount of Rescue Medication Taken	Week 12	1238.81 mg	Standard Deviation 3024.1
Tanezumab 5 mg + Placebo	Amount of Rescue Medication Taken	Week 2	2644.28 mg	Standard Deviation 4867.4
Tanezumab 5 mg + Placebo	Amount of Rescue Medication Taken	Week 16	1427.86 mg	Standard Deviation 3733.77
Tanezumab 10 mg + Placebo	Amount of Rescue Medication Taken	Week 16	1458.13 mg	Standard Deviation 4081.41
Tanezumab 10 mg + Placebo	Amount of Rescue Medication Taken	Week 2	2546.80 mg	Standard Deviation 3691.91
Tanezumab 10 mg + Placebo	Amount of Rescue Medication Taken	Week 4	1795.57 mg	Standard Deviation 4134.95
Tanezumab 10 mg + Placebo	Amount of Rescue Medication Taken	Week 8	1423.65 mg	Standard Deviation 3833.84
Tanezumab 10 mg + Placebo	Amount of Rescue Medication Taken	Week 12	1504.93 mg	Standard Deviation 4054.39
Naproxen + Placebo	Amount of Rescue Medication Taken	Week 16	1872.50 mg	Standard Deviation 3967.52
Naproxen + Placebo	Amount of Rescue Medication Taken	Week 12	1800.00 mg	Standard Deviation 4034.4
Naproxen + Placebo	Amount of Rescue Medication Taken	Week 4	2210.00 mg	Standard Deviation 3887.99
Naproxen + Placebo	Amount of Rescue Medication Taken	Week 2	2025.13 mg	Standard Deviation 3468.75
Naproxen + Placebo	Amount of Rescue Medication Taken	Week 8	1987.50 mg	Standard Deviation 3967.02

Secondary

Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.46 units on a scale	Standard Deviation 1.83
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.23 units on a scale	Standard Deviation 2.08
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.34 units on a scale	Standard Deviation 2.27
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.48 units on a scale	Standard Deviation 2.34
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.53 units on a scale	Standard Deviation 2.32
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.44 units on a scale	Standard Deviation 2.25
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.54 units on a scale	Standard Deviation 2.77
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.52 units on a scale	Standard Deviation 2.72
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.51 units on a scale	Standard Deviation 1.98
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.46 units on a scale	Standard Deviation 2.52
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.80 units on a scale	Standard Deviation 2.45
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.82 units on a scale	Standard Deviation 2.8
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.08 units on a scale	Standard Deviation 2.2
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.91 units on a scale	Standard Deviation 2.52
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.92 units on a scale	Standard Deviation 2.61
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.48 units on a scale	Standard Deviation 2.67
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.79 units on a scale	Standard Deviation 2.63
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.58 units on a scale	Standard Deviation 1.7
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.30 units on a scale	Standard Deviation 2.68
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.21 units on a scale	Standard Deviation 2.53
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.39 units on a scale	Standard Deviation 2.28
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.42 units on a scale	Standard Deviation 2.63
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	6.70 units on a scale	Standard Deviation 1.99
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.33 units on a scale	Standard Deviation 2.33

Secondary

Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	6.43 units on a scale	Standard Deviation 1.84
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.25 units on a scale	Standard Deviation 2.1
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.33 units on a scale	Standard Deviation 2.38
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-1.45 units on a scale	Standard Deviation 2.51
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-1.68 units on a scale	Standard Deviation 2.7
Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-1.67 units on a scale	Standard Deviation 2.68
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.79 units on a scale	Standard Deviation 2.75
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.66 units on a scale	Standard Deviation 2.69
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	6.51 units on a scale	Standard Deviation 1.97
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.58 units on a scale	Standard Deviation 2.54
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.84 units on a scale	Standard Deviation 2.46
Tanezumab 5 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.03 units on a scale	Standard Deviation 2.73
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.09 units on a scale	Standard Deviation 2.2
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.96 units on a scale	Standard Deviation 2.54
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.13 units on a scale	Standard Deviation 2.58
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.96 units on a scale	Standard Deviation 2.66
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.20 units on a scale	Standard Deviation 2.59
Tanezumab 10 mg + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	6.60 units on a scale	Standard Deviation 1.7
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.67 units on a scale	Standard Deviation 2.67
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.60 units on a scale	Standard Deviation 2.56
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.39 units on a scale	Standard Deviation 2.28
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.49 units on a scale	Standard Deviation 2.62
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	6.69 units on a scale	Standard Deviation 1.99
Naproxen + Placebo	Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.40 units on a scale	Standard Deviation 2.32

Secondary

Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Time frame: Baseline, Week 2, 4, 8, 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.53 units on a scale	Standard Deviation 0.78
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-0.52 units on a scale	Standard Deviation 0.75
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.52 units on a scale	Standard Deviation 0.81
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.53 units on a scale	Standard Deviation 0.74
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.02 units on a scale	Standard Deviation 0.98
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.95 units on a scale	Standard Deviation 0.97
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.98 units on a scale	Standard Deviation 1
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.69 units on a scale	Standard Deviation 0.91
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.96 units on a scale	Standard Deviation 0.95
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.07 units on a scale	Standard Deviation 0.9
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.83 units on a scale	Standard Deviation 0.94
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.68 units on a scale	Standard Deviation 0.9
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-0.73 units on a scale	Standard Deviation 0.87
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-0.89 units on a scale	Standard Deviation 0.85
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-0.89 units on a scale	Standard Deviation 0.94
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-0.77 units on a scale	Standard Deviation 0.96

Comparison: Week 2: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.p-value: 0.04595% CI: [-0.32, 0]ANCOVA

Comparison: Week 4: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.p-value: <0.00195% CI: [-0.66, -0.35]ANCOVA

Comparison: Week 8: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.p-value: <0.00195% CI: [-0.6, -0.27]ANCOVA

Comparison: Week 12: LS mean was estimated from the corresponding ANCOVA model. ANCOVA model included treatment as main effects, baseline value, and study site as a random effect. 95% CI was calculated on LS mean difference.p-value: <0.00195% CI: [-0.6, -0.26]ANCOVA

Secondary

Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 2, 4, 8, 12

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.56 units on a scale	Standard Deviation 0.83
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.53 units on a scale	Standard Deviation 0.78
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-0.63 units on a scale	Standard Deviation 0.83
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-0.54 units on a scale	Standard Deviation 0.76
Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	3.41 units on a scale	Standard Deviation 0.61
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.01 units on a scale	Standard Deviation 1.01
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.96 units on a scale	Standard Deviation 1
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-1.01 units on a scale	Standard Deviation 1.04
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.69 units on a scale	Standard Deviation 0.91
Tanezumab 5 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	3.41 units on a scale	Standard Deviation 0.59
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.10 units on a scale	Standard Deviation 0.91
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	3.39 units on a scale	Standard Deviation 0.55
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.68 units on a scale	Standard Deviation 0.9
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-1.05 units on a scale	Standard Deviation 0.95
Tanezumab 10 mg + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-0.98 units on a scale	Standard Deviation 0.96
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.81 units on a scale	Standard Deviation 0.95
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-0.89 units on a scale	Standard Deviation 0.94
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	3.44 units on a scale	Standard Deviation 0.62
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-0.91 units on a scale	Standard Deviation 0.85
Naproxen + Placebo	Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-0.82 units on a scale	Standard Deviation 0.89

Secondary

Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 12, 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12: MCA	0.15 units on a scale	Standard Deviation 0.7
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 3	9.64 units on a scale	Standard Deviation 21.87
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 4	33.72 units on a scale	Standard Deviation 17.09
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 5	3.98 units on a scale	Standard Deviation 13.51
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 4	13.67 units on a scale	Standard Deviation 20.32
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 4	11.23 units on a scale	Standard Deviation 18.48
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16: MCA	0.09 units on a scale	Standard Deviation 0.81
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 5	4.39 units on a scale	Standard Deviation 12.54
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 5	53.09 units on a scale	Standard Deviation 20.63
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 7	4.61 units on a scale	Standard Deviation 23.5
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: PCA	-1.92 units on a scale	Standard Deviation 0.74
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 8	1.66 units on a scale	Standard Deviation 13.81
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12: PCA	0.47 units on a scale	Standard Deviation 0.74
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 7	6.03 units on a scale	Standard Deviation 19.98
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16: PCA	0.42 units on a scale	Standard Deviation 0.73
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 1	66.03 units on a scale	Standard Deviation 19.88
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 7	70.69 units on a scale	Standard Deviation 32.12
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 1	4.13 units on a scale	Standard Deviation 11.47
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 1	3.42 units on a scale	Standard Deviation 11.57
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 2	30.45 units on a scale	Standard Deviation 19.83
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: MCA	0.31 units on a scale	Standard Deviation 1.27
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 6	6.97 units on a scale	Standard Deviation 20.78
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 2	10.15 units on a scale	Standard Deviation 18.5
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 2	8.74 units on a scale	Standard Deviation 17.38
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 8	2.94 units on a scale	Standard Deviation 11.39
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 6	9.05 units on a scale	Standard Deviation 21.02
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 3	43.62 units on a scale	Standard Deviation 25.48
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 8	76.06 units on a scale	Standard Deviation 18.01
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 3	10.77 units on a scale	Standard Deviation 22.74
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 6	69.28 units on a scale	Standard Deviation 27.86
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 3	20.00 units on a scale	Standard Deviation 26.45
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 1	67.19 units on a scale	Standard Deviation 17.71
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 3	17.33 units on a scale	Standard Deviation 27.01
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12: MCA	0.16 units on a scale	Standard Deviation 1.03
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 5	8.83 units on a scale	Standard Deviation 17.22
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 8	3.21 units on a scale	Standard Deviation 15.31
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 4	33.65 units on a scale	Standard Deviation 16.04
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 8	3.46 units on a scale	Standard Deviation 16.38
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 2	18.45 units on a scale	Standard Deviation 22.97
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: MCA	0.26 units on a scale	Standard Deviation 1.21
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 4	23.08 units on a scale	Standard Deviation 23.15
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 7	8.46 units on a scale	Standard Deviation 23.88
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 5	10.29 units on a scale	Standard Deviation 18.21
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 1	6.33 units on a scale	Standard Deviation 13.62
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 4	18.99 units on a scale	Standard Deviation 22.9
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12: PCA	0.88 units on a scale	Standard Deviation 0.9
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 6	11.82 units on a scale	Standard Deviation 25.32
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 1	4.03 units on a scale	Standard Deviation 14.02
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 5	51.00 units on a scale	Standard Deviation 21.81
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16: MCA	0.19 units on a scale	Standard Deviation 0.93
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16: PCA	0.71 units on a scale	Standard Deviation 0.89
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 8	75.80 units on a scale	Standard Deviation 17.76
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 6	11.63 units on a scale	Standard Deviation 24.76
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: PCA	-1.85 units on a scale	Standard Deviation 0.76
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 6	68.53 units on a scale	Standard Deviation 26.43
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 7	9.00 units on a scale	Standard Deviation 26.96
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 2	32.69 units on a scale	Standard Deviation 19.88
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 2	15.38 units on a scale	Standard Deviation 21.77
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 3	44.21 units on a scale	Standard Deviation 26.1
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 7	71.52 units on a scale	Standard Deviation 29.63
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16: PCA	0.66 units on a scale	Standard Deviation 0.87
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 8	3.66 units on a scale	Standard Deviation 12.94
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 8	2.97 units on a scale	Standard Deviation 12.37
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: MCA	0.25 units on a scale	Standard Deviation 1.15
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12: MCA	0.07 units on a scale	Standard Deviation 0.76
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16: MCA	0.06 units on a scale	Standard Deviation 0.71
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: PCA	-1.78 units on a scale	Standard Deviation 0.72
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 1	67.64 units on a scale	Standard Deviation 19.71
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 1	3.23 units on a scale	Standard Deviation 11.6
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 1	3.31 units on a scale	Standard Deviation 11.32
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 2	34.53 units on a scale	Standard Deviation 18.96
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 2	17.47 units on a scale	Standard Deviation 23.51
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 2	13.94 units on a scale	Standard Deviation 22.15
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 3	46.50 units on a scale	Standard Deviation 23.89
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 3	17.57 units on a scale	Standard Deviation 25.61
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 3	15.10 units on a scale	Standard Deviation 23.84
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 4	33.72 units on a scale	Standard Deviation 14.85
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 4	21.07 units on a scale	Standard Deviation 23.88
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 4	16.76 units on a scale	Standard Deviation 21.85
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 5	52.32 units on a scale	Standard Deviation 18.93
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 5	6.96 units on a scale	Standard Deviation 16.19
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 5	7.52 units on a scale	Standard Deviation 14.84
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 6	69.86 units on a scale	Standard Deviation 25.08
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 6	8.48 units on a scale	Standard Deviation 21.71
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 6	7.43 units on a scale	Standard Deviation 18.8
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 7	72.94 units on a scale	Standard Deviation 27.16
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 7	6.06 units on a scale	Standard Deviation 18.7
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 7	4.21 units on a scale	Standard Deviation 18.78
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 8	74.48 units on a scale	Standard Deviation 17.95
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12: PCA	0.77 units on a scale	Standard Deviation 0.93
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 3	45.44 units on a scale	Standard Deviation 25.54
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: MCA	0.24 units on a scale	Standard Deviation 1.21
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 6	67.94 units on a scale	Standard Deviation 25.48
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 2	11.08 units on a scale	Standard Deviation 19.04
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 2	12.69 units on a scale	Standard Deviation 19.68
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 8	2.31 units on a scale	Standard Deviation 13.32
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 6	9.44 units on a scale	Standard Deviation 20.84
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 2	31.93 units on a scale	Standard Deviation 18.48
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 1	3.62 units on a scale	Standard Deviation 12.4
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 7	4.62 units on a scale	Standard Deviation 21.99
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 6	8.00 units on a scale	Standard Deviation 22.9
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 1	65.16 units on a scale	Standard Deviation 19.77
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16: PCA	0.51 units on a scale	Standard Deviation 0.81
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 8	2.56 units on a scale	Standard Deviation 13.5
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 7	71.54 units on a scale	Standard Deviation 29.22
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12: PCA	0.59 units on a scale	Standard Deviation 0.8
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: PCA	-1.86 units on a scale	Standard Deviation 0.78
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 8	74.91 units on a scale	Standard Deviation 17.79
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 7	4.88 units on a scale	Standard Deviation 24.57
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16: MCA	0.10 units on a scale	Standard Deviation 0.86
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 5	51.84 units on a scale	Standard Deviation 20.54
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 4	13.19 units on a scale	Standard Deviation 21.19
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 4	14.93 units on a scale	Standard Deviation 20.47
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12: MCA	0.11 units on a scale	Standard Deviation 0.84
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 5	7.19 units on a scale	Standard Deviation 14.89
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline: Domain 4	34.02 units on a scale	Standard Deviation 16.74
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 3	11.69 units on a scale	Standard Deviation 22.79
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 1	4.12 units on a scale	Standard Deviation 13.11
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16:Domain 5	5.66 units on a scale	Standard Deviation 14.86
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12:Domain 3	13.03 units on a scale	Standard Deviation 24.97

Secondary

Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 12, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 6	9.05 units on a scale	Standard Deviation 21.02
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 6	69.28 units on a scale	Standard Deviation 27.86
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 3	10.05 units on a scale	Standard Deviation 22.09
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12: MCA	0.15 units on a scale	Standard Deviation 0.7
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 5	4.36 units on a scale	Standard Deviation 14.22
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 5	4.39 units on a scale	Standard Deviation 12.54
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 4	33.72 units on a scale	Standard Deviation 17.09
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: MCA	0.31 units on a scale	Standard Deviation 1.27
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 5	53.09 units on a scale	Standard Deviation 20.63
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 4	11.53 units on a scale	Standard Deviation 18.48
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 4	13.67 units on a scale	Standard Deviation 20.32
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 2	9.80 units on a scale	Standard Deviation 18.4
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: PCA	-1.92 units on a scale	Standard Deviation 0.74
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 8	1.93 units on a scale	Standard Deviation 14.36
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 1	4.13 units on a scale	Standard Deviation 11.47
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16: PCA	0.45 units on a scale	Standard Deviation 0.74
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 1	66.03 units on a scale	Standard Deviation 19.88
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 1	3.61 units on a scale	Standard Deviation 11.72
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 8	2.94 units on a scale	Standard Deviation 11.39
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 8	76.06 units on a scale	Standard Deviation 18.01
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 2	30.45 units on a scale	Standard Deviation 19.83
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16: MCA	0.10 units on a scale	Standard Deviation 0.83
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 7	4.90 units on a scale	Standard Deviation 23.69
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 7	6.03 units on a scale	Standard Deviation 19.98
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 3	43.62 units on a scale	Standard Deviation 25.48
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 2	10.15 units on a scale	Standard Deviation 18.5
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 7	70.69 units on a scale	Standard Deviation 32.12
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 6	7.29 units on a scale	Standard Deviation 20.84
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 3	10.77 units on a scale	Standard Deviation 22.74
Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12: PCA	0.47 units on a scale	Standard Deviation 0.74
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 8	3.46 units on a scale	Standard Deviation 16.38
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 1	67.19 units on a scale	Standard Deviation 17.71
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 1	4.76 units on a scale	Standard Deviation 14.31
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 2	18.45 units on a scale	Standard Deviation 22.97
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 2	17.14 units on a scale	Standard Deviation 21.58
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 1	6.33 units on a scale	Standard Deviation 13.62
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 2	32.69 units on a scale	Standard Deviation 19.88
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 3	44.21 units on a scale	Standard Deviation 26.1
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 3	20.00 units on a scale	Standard Deviation 26.45
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 3	19.04 units on a scale	Standard Deviation 26.83
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 4	33.65 units on a scale	Standard Deviation 16.04
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 4	23.08 units on a scale	Standard Deviation 23.15
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 4	21.16 units on a scale	Standard Deviation 22.93
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 5	51.00 units on a scale	Standard Deviation 21.81
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 5	10.29 units on a scale	Standard Deviation 18.21
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 5	9.20 units on a scale	Standard Deviation 17.5
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 6	68.53 units on a scale	Standard Deviation 26.43
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 6	11.82 units on a scale	Standard Deviation 25.32
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 6	12.13 units on a scale	Standard Deviation 25.06
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 7	71.52 units on a scale	Standard Deviation 29.63
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 7	9.00 units on a scale	Standard Deviation 26.96
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 7	8.91 units on a scale	Standard Deviation 24.12
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 8	75.80 units on a scale	Standard Deviation 17.76
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 8	3.21 units on a scale	Standard Deviation 15.72
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: MCA	0.26 units on a scale	Standard Deviation 1.21
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12: MCA	0.16 units on a scale	Standard Deviation 1.03
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16: MCA	0.17 units on a scale	Standard Deviation 0.95
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: PCA	-1.85 units on a scale	Standard Deviation 0.76
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12: PCA	0.88 units on a scale	Standard Deviation 0.9
Tanezumab 5 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16: PCA	0.80 units on a scale	Standard Deviation 0.88
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 8	3.66 units on a scale	Standard Deviation 12.94
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 3	17.57 units on a scale	Standard Deviation 25.61
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 2	15.48 units on a scale	Standard Deviation 22.71
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16: PCA	0.73 units on a scale	Standard Deviation 0.88
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 8	3.56 units on a scale	Standard Deviation 13.42
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: PCA	-1.78 units on a scale	Standard Deviation 0.72
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 7	6.06 units on a scale	Standard Deviation 18.7
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12: PCA	0.77 units on a scale	Standard Deviation 0.93
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: MCA	0.25 units on a scale	Standard Deviation 1.15
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 1	3.23 units on a scale	Standard Deviation 11.6
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 2	17.47 units on a scale	Standard Deviation 23.51
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 2	34.53 units on a scale	Standard Deviation 18.96
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 4	21.07 units on a scale	Standard Deviation 23.88
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 6	8.79 units on a scale	Standard Deviation 20.15
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 7	5.57 units on a scale	Standard Deviation 20.13
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12: MCA	0.07 units on a scale	Standard Deviation 0.76
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 4	19.19 units on a scale	Standard Deviation 22.71
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 6	69.86 units on a scale	Standard Deviation 25.08
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 4	33.72 units on a scale	Standard Deviation 14.85
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 3	46.50 units on a scale	Standard Deviation 23.89
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 5	52.32 units on a scale	Standard Deviation 18.93
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 6	8.48 units on a scale	Standard Deviation 21.71
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 8	74.48 units on a scale	Standard Deviation 17.95
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 7	72.94 units on a scale	Standard Deviation 27.16
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 5	6.96 units on a scale	Standard Deviation 16.19
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 1	3.47 units on a scale	Standard Deviation 11.73
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 3	17.23 units on a scale	Standard Deviation 24.53
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 1	67.64 units on a scale	Standard Deviation 19.71
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 5	8.35 units on a scale	Standard Deviation 15.53
Tanezumab 10 mg + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16: MCA	0.10 units on a scale	Standard Deviation 0.76
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 5	6.22 units on a scale	Standard Deviation 15.43
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 6	67.94 units on a scale	Standard Deviation 25.48
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16: MCA	0.11 units on a scale	Standard Deviation 0.9
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 6	9.44 units on a scale	Standard Deviation 20.84
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 3	45.44 units on a scale	Standard Deviation 25.54
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 6	8.81 units on a scale	Standard Deviation 23.57
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16: PCA	0.56 units on a scale	Standard Deviation 0.82
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 7	71.54 units on a scale	Standard Deviation 29.22
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 2	11.80 units on a scale	Standard Deviation 19.21
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 7	4.88 units on a scale	Standard Deviation 24.57
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: PCA	-1.86 units on a scale	Standard Deviation 0.78
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 7	4.92 units on a scale	Standard Deviation 23.06
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 1	4.23 units on a scale	Standard Deviation 13.16
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 1	65.16 units on a scale	Standard Deviation 19.77
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 8	74.91 units on a scale	Standard Deviation 17.79
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 1	4.12 units on a scale	Standard Deviation 13.11
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 8	2.56 units on a scale	Standard Deviation 13.5
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 8	2.59 units on a scale	Standard Deviation 13.78
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 2	12.69 units on a scale	Standard Deviation 19.68
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: MCA	0.24 units on a scale	Standard Deviation 1.21
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12: PCA	0.59 units on a scale	Standard Deviation 0.8
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 4	14.93 units on a scale	Standard Deviation 20.47
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 4	34.02 units on a scale	Standard Deviation 16.74
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 4	14.50 units on a scale	Standard Deviation 21.46
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12: MCA	0.11 units on a scale	Standard Deviation 0.84
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 5	51.84 units on a scale	Standard Deviation 20.54
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16:Domain 3	12.59 units on a scale	Standard Deviation 23.53
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Baseline: Domain 2	31.93 units on a scale	Standard Deviation 18.48
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 5	7.19 units on a scale	Standard Deviation 14.89
Naproxen + Placebo	Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12:Domain 3	13.03 units on a scale	Standard Deviation 24.97

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.00 units on a scale	Standard Deviation 2.35
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.99 units on a scale	Standard Deviation 2.12
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.95 units on a scale	Standard Deviation 2.3
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.02 units on a scale	Standard Deviation 2.21
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.03 units on a scale	Standard Deviation 2.14
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.03 units on a scale	Standard Deviation 1.48
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.56 units on a scale	Standard Deviation 2.47
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.11 units on a scale	Standard Deviation 1.46
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.35 units on a scale	Standard Deviation 2.49
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.41 units on a scale	Standard Deviation 2.49
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.35 units on a scale	Standard Deviation 2.66
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.69 units on a scale	Standard Deviation 2.69
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.05 units on a scale	Standard Deviation 1.38
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.91 units on a scale	Standard Deviation 2.34
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.48 units on a scale	Standard Deviation 2.77
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.70 units on a scale	Standard Deviation 2.6
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.12 units on a scale	Standard Deviation 2.69
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.82 units on a scale	Standard Deviation 2.49
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.52 units on a scale	Standard Deviation 2.43
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.02 units on a scale	Standard Deviation 1.37
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.86 units on a scale	Standard Deviation 2.35
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.02 units on a scale	Standard Deviation 2.33
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.81 units on a scale	Standard Deviation 2.49
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.75 units on a scale	Standard Deviation 2.51

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.44 units on a scale	Standard Deviation 2.36
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.37 units on a scale	Standard Deviation 2.33
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.03 units on a scale	Standard Deviation 1.48
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.99 units on a scale	Standard Deviation 2.12
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.13 units on a scale	Standard Deviation 2.23
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.23 units on a scale	Standard Deviation 2.18
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.52 units on a scale	Standard Deviation 2.49
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.56 units on a scale	Standard Deviation 2.47
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.89 units on a scale	Standard Deviation 2.61
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.11 units on a scale	Standard Deviation 1.46
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.67 units on a scale	Standard Deviation 2.53
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.36 units on a scale	Standard Deviation 2.54
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.82 units on a scale	Standard Deviation 2.38
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.05 units on a scale	Standard Deviation 1.38
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.91 units on a scale	Standard Deviation 2.34
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-4.00 units on a scale	Standard Deviation 2.41
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.94 units on a scale	Standard Deviation 2.38
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.02 units on a scale	Standard Deviation 2.46
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.06 units on a scale	Standard Deviation 2.31
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.94 units on a scale	Standard Deviation 2.45
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.96 units on a scale	Standard Deviation 2.39
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.86 units on a scale	Standard Deviation 2.35
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.06 units on a scale	Standard Deviation 2.47
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.02 units on a scale	Standard Deviation 1.37

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	8.24 units on a scale	Standard Deviation 1.33
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.19 units on a scale	Standard Deviation 2.5
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.18 units on a scale	Standard Deviation 2.49
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.15 units on a scale	Standard Deviation 2.55
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.14 units on a scale	Standard Deviation 2.7
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.21 units on a scale	Standard Deviation 2.73
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.61 units on a scale	Standard Deviation 3.05
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.65 units on a scale	Standard Deviation 2.89
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	8.29 units on a scale	Standard Deviation 1.43
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.61 units on a scale	Standard Deviation 2.72
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.86 units on a scale	Standard Deviation 2.78
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-4.01 units on a scale	Standard Deviation 3
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.10 units on a scale	Standard Deviation 2.68
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-4.18 units on a scale	Standard Deviation 2.9
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.98 units on a scale	Standard Deviation 3
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.38 units on a scale	Standard Deviation 3.09
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.79 units on a scale	Standard Deviation 3.17
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	8.15 units on a scale	Standard Deviation 1.47
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.06 units on a scale	Standard Deviation 2.96
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.93 units on a scale	Standard Deviation 2.77
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.24 units on a scale	Standard Deviation 2.75
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.25 units on a scale	Standard Deviation 2.86
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	8.30 units on a scale	Standard Deviation 1.35
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.39 units on a scale	Standard Deviation 2.76

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.19 units on a scale	Standard Deviation 2.5
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.61 units on a scale	Standard Deviation 2.68
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	8.24 units on a scale	Standard Deviation 1.33
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.65 units on a scale	Standard Deviation 2.71
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.30 units on a scale	Standard Deviation 2.52
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.38 units on a scale	Standard Deviation 2.57
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.65 units on a scale	Standard Deviation 2.7
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.25 units on a scale	Standard Deviation 2.83
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.99 units on a scale	Standard Deviation 2.84
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.86 units on a scale	Standard Deviation 2.78
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	8.29 units on a scale	Standard Deviation 1.43
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.81 units on a scale	Standard Deviation 2.82
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-4.33 units on a scale	Standard Deviation 2.77
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-4.36 units on a scale	Standard Deviation 2.77
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	8.15 units on a scale	Standard Deviation 1.47
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.10 units on a scale	Standard Deviation 2.68
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.35 units on a scale	Standard Deviation 2.84
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-4.10 units on a scale	Standard Deviation 2.78
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.48 units on a scale	Standard Deviation 2.69
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.46 units on a scale	Standard Deviation 2.91
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.24 units on a scale	Standard Deviation 2.75
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	8.30 units on a scale	Standard Deviation 1.35
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.40 units on a scale	Standard Deviation 2.84
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.44 units on a scale	Standard Deviation 2.73

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.22 units on a scale	Standard Deviation 1.65
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.40 units on a scale	Standard Deviation 2.43
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.36 units on a scale	Standard Deviation 2.49
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.41 units on a scale	Standard Deviation 2.52
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.28 units on a scale	Standard Deviation 2.67
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.26 units on a scale	Standard Deviation 2.7
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.39 units on a scale	Standard Deviation 3
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.52 units on a scale	Standard Deviation 2.78
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.16 units on a scale	Standard Deviation 1.79
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.49 units on a scale	Standard Deviation 2.67
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.52 units on a scale	Standard Deviation 2.72
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.73 units on a scale	Standard Deviation 2.91
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.96 units on a scale	Standard Deviation 2.65
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.89 units on a scale	Standard Deviation 2.7
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.80 units on a scale	Standard Deviation 2.84
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.10 units on a scale	Standard Deviation 2.83
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.50 units on a scale	Standard Deviation 2.98
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.08 units on a scale	Standard Deviation 1.7
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.98 units on a scale	Standard Deviation 2.77
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.72 units on a scale	Standard Deviation 2.63
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.05 units on a scale	Standard Deviation 2.6
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.05 units on a scale	Standard Deviation 2.72
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.04 units on a scale	Standard Deviation 1.71
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.30 units on a scale	Standard Deviation 2.48

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.71 units on a scale	Standard Deviation 2.53
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.58 units on a scale	Standard Deviation 2.51
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.84 units on a scale	Standard Deviation 2.68
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.87 units on a scale	Standard Deviation 2.64
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.40 units on a scale	Standard Deviation 2.43
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.22 units on a scale	Standard Deviation 1.65
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.16 units on a scale	Standard Deviation 1.79
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.52 units on a scale	Standard Deviation 2.72
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.53 units on a scale	Standard Deviation 2.65
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.65 units on a scale	Standard Deviation 2.74
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.94 units on a scale	Standard Deviation 2.78
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.71 units on a scale	Standard Deviation 2.83
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.96 units on a scale	Standard Deviation 2.65
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-4.11 units on a scale	Standard Deviation 2.66
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.77 units on a scale	Standard Deviation 2.63
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.01 units on a scale	Standard Deviation 2.72
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.08 units on a scale	Standard Deviation 1.7
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-4.02 units on a scale	Standard Deviation 2.63
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.35 units on a scale	Standard Deviation 2.44
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.28 units on a scale	Standard Deviation 2.5
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.40 units on a scale	Standard Deviation 2.66
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.23 units on a scale	Standard Deviation 2.65
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.04 units on a scale	Standard Deviation 1.71
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.05 units on a scale	Standard Deviation 2.6

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Time frame: Baseline, Week 2, 4, 8, 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.34 units on a scale	Standard Deviation 2.26
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.36 units on a scale	Standard Deviation 2.31
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.35 units on a scale	Standard Deviation 2.35
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.24 units on a scale	Standard Deviation 2.56
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.59 units on a scale	Standard Deviation 2.52
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.63 units on a scale	Standard Deviation 2.61
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.89 units on a scale	Standard Deviation 2.83
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.61 units on a scale	Standard Deviation 2.58
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.89 units on a scale	Standard Deviation 2.77
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.99 units on a scale	Standard Deviation 2.64
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.65 units on a scale	Standard Deviation 2.92
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.95 units on a scale	Standard Deviation 2.53
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.98 units on a scale	Standard Deviation 2.65
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.28 units on a scale	Standard Deviation 2.41
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-3.12 units on a scale	Standard Deviation 2.37
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.13 units on a scale	Standard Deviation 2.57

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 2, 4, 8, 12

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.62 units on a scale	Standard Deviation 2.35
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.34 units on a scale	Standard Deviation 2.26
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.80 units on a scale	Standard Deviation 2.5
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.53 units on a scale	Standard Deviation 2.32
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	7.21 units on a scale	Standard Deviation 1.43
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.58 units on a scale	Standard Deviation 2.56
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.73 units on a scale	Standard Deviation 2.6
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.07 units on a scale	Standard Deviation 2.72
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.61 units on a scale	Standard Deviation 2.58
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	7.30 units on a scale	Standard Deviation 1.47
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-4.14 units on a scale	Standard Deviation 2.51
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	7.25 units on a scale	Standard Deviation 1.41
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.95 units on a scale	Standard Deviation 2.53
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-4.24 units on a scale	Standard Deviation 2.53
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.21 units on a scale	Standard Deviation 2.56
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.26 units on a scale	Standard Deviation 2.52
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-3.12 units on a scale	Standard Deviation 2.37
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	7.18 units on a scale	Standard Deviation 1.37
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.32 units on a scale	Standard Deviation 2.39
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.34 units on a scale	Standard Deviation 2.58

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.92 units on a scale	Standard Deviation 2.09
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.92 units on a scale	Standard Deviation 2.19
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.96 units on a scale	Standard Deviation 2.14
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.93 units on a scale	Standard Deviation 2.28
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.07 units on a scale	Standard Deviation 2.47
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.18 units on a scale	Standard Deviation 2.47
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.46 units on a scale	Standard Deviation 2.7
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.44 units on a scale	Standard Deviation 2.48
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.50 units on a scale	Standard Deviation 2.57
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.63 units on a scale	Standard Deviation 2.46
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.32 units on a scale	Standard Deviation 2.72
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.80 units on a scale	Standard Deviation 2.35
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.66 units on a scale	Standard Deviation 2.53
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.90 units on a scale	Standard Deviation 2.38
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.66 units on a scale	Standard Deviation 2.4
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.70 units on a scale	Standard Deviation 2.52

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.13 units on a scale	Standard Deviation 2.22
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.92 units on a scale	Standard Deviation 2.09
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.31 units on a scale	Standard Deviation 2.35
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.02 units on a scale	Standard Deviation 2.23
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	6.85 units on a scale	Standard Deviation 1.56
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.07 units on a scale	Standard Deviation 2.54
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.27 units on a scale	Standard Deviation 2.5
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.61 units on a scale	Standard Deviation 2.67
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.44 units on a scale	Standard Deviation 2.48
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.71
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.73 units on a scale	Standard Deviation 2.4
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.5
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.80 units on a scale	Standard Deviation 2.35
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.77 units on a scale	Standard Deviation 2.45
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.79 units on a scale	Standard Deviation 2.51
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.83 units on a scale	Standard Deviation 2.51
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.66 units on a scale	Standard Deviation 2.4
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Baseline	6.86 units on a scale	Standard Deviation 1.57
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.93 units on a scale	Standard Deviation 2.37
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.95 units on a scale	Standard Deviation 2.52

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.04 units on a scale	Standard Deviation 1.88
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-1.69 units on a scale	Standard Deviation 2.36
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-1.76 units on a scale	Standard Deviation 2.44
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-1.77 units on a scale	Standard Deviation 2.26
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-1.82 units on a scale	Standard Deviation 2.4
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-1.72 units on a scale	Standard Deviation 2.27
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.33 units on a scale	Standard Deviation 2.84
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.42 units on a scale	Standard Deviation 2.73
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.17 units on a scale	Standard Deviation 1.72
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.40 units on a scale	Standard Deviation 2.81
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.63 units on a scale	Standard Deviation 2.78
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.73 units on a scale	Standard Deviation 2.88
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.98 units on a scale	Standard Deviation 2.63
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-3.84 units on a scale	Standard Deviation 2.73
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-3.68 units on a scale	Standard Deviation 2.81
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-3.16 units on a scale	Standard Deviation 2.93
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-3.46 units on a scale	Standard Deviation 2.94
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.04 units on a scale	Standard Deviation 1.75
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 12	-2.62 units on a scale	Standard Deviation 2.7
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 16	-2.31 units on a scale	Standard Deviation 2.68
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 2	-2.81 units on a scale	Standard Deviation 2.67
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 8	-2.60 units on a scale	Standard Deviation 2.76
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Baseline	7.02 units on a scale	Standard Deviation 1.76
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)	Change at Week 4	-2.87 units on a scale	Standard Deviation 2.63

Secondary

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.69 units on a scale	Standard Deviation 2.36
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.04 units on a scale	Standard Deviation 1.88
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.81 units on a scale	Standard Deviation 2.53
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-1.95 units on a scale	Standard Deviation 2.34
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.18 units on a scale	Standard Deviation 2.54
Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.07 units on a scale	Standard Deviation 2.43
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.73 units on a scale	Standard Deviation 2.8
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-3.57 units on a scale	Standard Deviation 2.78
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.17 units on a scale	Standard Deviation 1.72
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.42 units on a scale	Standard Deviation 2.89
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.63 units on a scale	Standard Deviation 2.78
Tanezumab 5 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-3.99 units on a scale	Standard Deviation 2.86
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.98 units on a scale	Standard Deviation 2.63
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-3.95 units on a scale	Standard Deviation 2.63
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-4.00 units on a scale	Standard Deviation 2.68
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-3.91 units on a scale	Standard Deviation 2.68
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-4.05 units on a scale	Standard Deviation 2.7
Tanezumab 10 mg + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.04 units on a scale	Standard Deviation 1.75
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Baseline	7.02 units on a scale	Standard Deviation 1.76
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.91 units on a scale	Standard Deviation 2.75
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-2.73 units on a scale	Standard Deviation 2.75
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-2.72 units on a scale	Standard Deviation 2.78
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 2	-2.81 units on a scale	Standard Deviation 2.67
Naproxen + Placebo	Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)	Change at Week 4	-2.92 units on a scale	Standard Deviation 2.62

Secondary

Number of Days Participants Used Rescue Medication

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.

Time frame: Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (MEDIAN)
Placebo	Number of Days Participants Used Rescue Medication	Week 12	0 days
Placebo	Number of Days Participants Used Rescue Medication	Week 4	1 days
Placebo	Number of Days Participants Used Rescue Medication	Week 16	0 days
Placebo	Number of Days Participants Used Rescue Medication	Week 8	1 days
Placebo	Number of Days Participants Used Rescue Medication	Week 2	1 days
Tanezumab 5 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 8	0 days
Tanezumab 5 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 12	0 days
Tanezumab 5 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 16	0 days
Tanezumab 5 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 4	0 days
Tanezumab 5 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 2	0 days
Tanezumab 10 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 8	0 days
Tanezumab 10 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 2	1 days
Tanezumab 10 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 4	0 days
Tanezumab 10 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 12	0 days
Tanezumab 10 mg + Placebo	Number of Days Participants Used Rescue Medication	Week 16	0 days
Naproxen + Placebo	Number of Days Participants Used Rescue Medication	Week 12	0 days
Naproxen + Placebo	Number of Days Participants Used Rescue Medication	Week 4	0 days
Naproxen + Placebo	Number of Days Participants Used Rescue Medication	Week 2	0 days
Naproxen + Placebo	Number of Days Participants Used Rescue Medication	Week 8	0 days
Naproxen + Placebo	Number of Days Participants Used Rescue Medication	Week 16	0 days

Secondary

Percentage of Participants Who Used Rescue Medication

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.

Time frame: Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Who Used Rescue Medication	Week 12	42.5 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 4	59.5 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 16	40.5 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 8	53.5 percentage of participants
Placebo	Percentage of Participants Who Used Rescue Medication	Week 2	62.5 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 8	35.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 12	29.4 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 16	26.9 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 4	35.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 2	47.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 8	33.0 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 2	58.6 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 4	38.9 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 12	30.5 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants Who Used Rescue Medication	Week 16	25.1 percentage of participants
Naproxen + Placebo	Percentage of Participants Who Used Rescue Medication	Week 12	32.0 percentage of participants
Naproxen + Placebo	Percentage of Participants Who Used Rescue Medication	Week 4	47.0 percentage of participants
Naproxen + Placebo	Percentage of Participants Who Used Rescue Medication	Week 2	49.7 percentage of participants
Naproxen + Placebo	Percentage of Participants Who Used Rescue Medication	Week 8	40.0 percentage of participants
Naproxen + Placebo	Percentage of Participants Who Used Rescue Medication	Week 16	36.0 percentage of participants

Secondary

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)

Time frame: Baseline, Week 2, 4, 8, 12, 16

Population: 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.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 12	12.5 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 4	9.0 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 16	13.5 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 8	9.5 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 2	11.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 8	29.2 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 12	31.7 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 16	25.2 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 4	29.7 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 2	17.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 8	28.6 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 2	16.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 4	30.0 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 12	24.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 16	19.8 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 12	18.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 4	22.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 2	25.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 8	19.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)	Week 16	19.5 percentage of participants

Secondary

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 4	9.0 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 2	11.0 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 8	10.0 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 16	16.0 percentage of participants
Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 12	14.5 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 16	27.7 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 2	17.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 4	29.7 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 8	29.7 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 12	33.7 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 4	31.5 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 8	31.5 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 12	29.1 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 2	16.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 16	24.6 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 4	22.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 12	20.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 8	20.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 2	25.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)	Week 16	22.5 percentage of participants

Secondary

Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)

Time frame: Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2: >=30 percent reduction	46.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2: >=50 percent reduction	29.6 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 4: >=30 percent reduction	47.2 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 4: >=50 percent reduction	30.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 8: >=30 percent reduction	44.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 8: >=50 percent reduction	31.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 12: >=30 percent reduction	44.2 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 12: >=50 percent reduction	32.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 16: >=30 percent reduction	42.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 16: >=50 percent reduction	31.2 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 4: >=30 percent reduction	65.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 16: >=30 percent reduction	65.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 4: >=50 percent reduction	52.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 8: >=30 percent reduction	68.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 8: >=50 percent reduction	53.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 12: >=30 percent reduction	69.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 16: >=50 percent reduction	52.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 12: >=50 percent reduction	57.4 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2: >=30 percent reduction	52.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2: >=50 percent reduction	36.1 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 12: >=50 percent reduction	57.9 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 12: >=30 percent reduction	65.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 16: >=50 percent reduction	52.0 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2: >=30 percent reduction	58.4 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 4: >=50 percent reduction	60.9 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 8: >=50 percent reduction	60.4 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 16: >=30 percent reduction	59.4 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2: >=50 percent reduction	41.6 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 8: >=30 percent reduction	70.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 4: >=30 percent reduction	72.8 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 8: >=30 percent reduction	62.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 12: >=50 percent reduction	46.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 8: >=50 percent reduction	46.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 16: >=50 percent reduction	41.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 12: >=30 percent reduction	58.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2: >=50 percent reduction	44.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 4: >=30 percent reduction	62.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 4: >=50 percent reduction	48.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 2: >=30 percent reduction	60.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)	Week 16: >=30 percent reduction	55.5 percentage of participants

Secondary

Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)

Time frame: Week 2, 4, 8, 12, 16

Population: 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

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 8: >=50 percent reduction	35.2 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 4: >=30 percent reduction	51.3 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 16: >=50 percent reduction	37.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2: >=30 percent reduction	46.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 16: >=30 percent reduction	54.3 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 4: >=50 percent reduction	32.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2: >=50 percent reduction	29.6 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 12: >=50 percent reduction	39.7 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 12: >=30 percent reduction	56.8 percentage of participants
Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 8: >=30 percent reduction	51.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 16: >=30 percent reduction	73.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 8: >=50 percent reduction	55.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 12: >=30 percent reduction	73.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2: >=50 percent reduction	36.1 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 16: >=50 percent reduction	55.9 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 8: >=30 percent reduction	71.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 4: >=30 percent reduction	66.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 4: >=50 percent reduction	52.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2: >=30 percent reduction	52.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 12: >=50 percent reduction	59.9 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 8: >=30 percent reduction	78.2 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2: >=30 percent reduction	58.4 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2: >=50 percent reduction	41.6 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 4: >=30 percent reduction	76.7 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 4: >=50 percent reduction	63.4 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 8: >=50 percent reduction	65.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 12: >=30 percent reduction	77.2 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 12: >=50 percent reduction	64.9 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 16: >=30 percent reduction	73.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 16: >=50 percent reduction	61.9 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 12: >=30 percent reduction	64.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 12: >=50 percent reduction	51.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 4: >=30 percent reduction	63.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2: >=50 percent reduction	44.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 16: >=50 percent reduction	47.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 16: >=30 percent reduction	65.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 8: >=50 percent reduction	48.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 2: >=30 percent reduction	60.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 8: >=30 percent reduction	65.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)	Week 4: >=50 percent reduction	49.5 percentage of participants

Secondary

Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

Time frame: Baseline up to Week 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0 percent	57.3 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=30 percent	42.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=70 percent	22.1 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=10 percent	54.3 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=60 percent	27.6 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=40 percent	36.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=20 percent	50.8 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	100 percent	3.0 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=90 percent	8.0 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=50 percent	31.2 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=80 percent	14.6 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=50 percent	52.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=80 percent	29.2 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=60 percent	49.5 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=70 percent	39.1 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=20 percent	68.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	100 percent	8.4 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=30 percent	65.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=90 percent	18.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=40 percent	60.4 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=10 percent	71.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0 percent	73.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=90 percent	17.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0 percent	69.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=10 percent	66.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=20 percent	64.4 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=30 percent	59.4 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=40 percent	56.4 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=50 percent	52.0 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=60 percent	47.0 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=70 percent	37.6 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=80 percent	25.2 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	100 percent	7.4 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=50 percent	41.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	100 percent	4.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=80 percent	18.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=40 percent	50.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=30 percent	55.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=20 percent	62.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=90 percent	11.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=10 percent	68.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	Greater than (>) 0 percent	71.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=70 percent	26.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)	>=60 percent	35.5 percentage of participants

Secondary

Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

Time frame: Baseline up to Week 16

Population: 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.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>0 percent	82.4 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=30 percent	54.3 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=70 percent	24.6 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=10 percent	75.4 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=60 percent	31.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=40 percent	45.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=20 percent	66.8 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	100 percent	3.5 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=90 percent	9.0 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=50 percent	37.7 percentage of participants
Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=80 percent	15.6 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=50 percent	55.9 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=80 percent	29.7 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=60 percent	53.0 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=70 percent	41.6 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=20 percent	77.7 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	100 percent	8.9 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=30 percent	73.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=90 percent	19.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=40 percent	66.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=10 percent	83.2 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>0 percent	87.6 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=90 percent	19.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>0 percent	92.1 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=10 percent	86.1 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=20 percent	82.2 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=30 percent	73.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=40 percent	68.3 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=50 percent	61.9 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=60 percent	54.5 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=70 percent	43.6 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=80 percent	28.7 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	100 percent	7.9 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=50 percent	47.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	100 percent	5.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=80 percent	21.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=40 percent	57.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=30 percent	65.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=20 percent	73.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=90 percent	13.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=10 percent	83.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>0 percent	91.5 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=70 percent	30.0 percentage of participants
Naproxen + Placebo	Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)	>=60 percent	41.0 percentage of participants

Secondary

Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)

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.

Time frame: Weeks 2, 4, 8, 12, 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 12	48.7 percentage of participants
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 4	53.3 percentage of participants
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 16	50.3 percentage of participants
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 8	50.3 percentage of participants
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 2	55.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 8	72.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 12	70.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 16	66.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 4	72.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 2	61.9 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 8	72.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 2	69.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 4	76.2 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 12	66.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 16	63.9 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 12	62.5 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 4	69.5 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 2	67.0 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 8	67.0 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)	Week 16	61.0 percentage of participants

Secondary

Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)

Time frame: Week 2, 4, 8, 12, 16

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 12	60.8 percentage of participants
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 4	56.3 percentage of participants
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 16	61.8 percentage of participants
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 8	56.3 percentage of participants
Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 2	55.3 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 8	76.7 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 12	77.2 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 16	75.2 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 4	73.8 percentage of participants
Tanezumab 5 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 2	61.9 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 8	81.7 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 2	69.8 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 4	81.2 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 12	80.2 percentage of participants
Tanezumab 10 mg + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 16	80.2 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 12	69.0 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 4	70.5 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 2	67.0 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 8	70.0 percentage of participants
Naproxen + Placebo	Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)	Week 16	70.0 percentage of participants

Secondary

Time to Discontinuation Due to Lack of Efficacy

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

Time frame: Baseline up to Week 16

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

Arm	Measure	Value (MEDIAN)
Placebo	Time to Discontinuation Due to Lack of Efficacy	NA days
Tanezumab 5 mg + Placebo	Time to Discontinuation Due to Lack of Efficacy	NA days
Tanezumab 10 mg + Placebo	Time to Discontinuation Due to Lack of Efficacy	NA days
Naproxen + Placebo	Time to Discontinuation Due to Lack of Efficacy	NA days

Other Pre-specified

Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24

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.

Time frame: Baseline, Week 2, 4, 8, 12, 16, 24

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Baseline	1.55 units on a scale	Standard Deviation 3.45
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 16	-0.11 units on a scale	Standard Deviation 1.7
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 12	-0.17 units on a scale	Standard Deviation 1.88
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 2	-0.14 units on a scale	Standard Deviation 1.34
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 24	-0.13 units on a scale	Standard Deviation 1.75
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 4	-0.02 units on a scale	Standard Deviation 1.78
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 8	-0.12 units on a scale	Standard Deviation 2.14
Tanezumab 5 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 16	-0.50 units on a scale	Standard Deviation 2.53
Tanezumab 5 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 8	-0.51 units on a scale	Standard Deviation 2.58
Tanezumab 5 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 4	-0.50 units on a scale	Standard Deviation 2.7
Tanezumab 5 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 12	-0.42 units on a scale	Standard Deviation 2.53
Tanezumab 5 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 24	-0.51 units on a scale	Standard Deviation 2.5
Tanezumab 5 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 2	-0.37 units on a scale	Standard Deviation 2.49
Tanezumab 5 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Baseline	1.75 units on a scale	Standard Deviation 3.9
Tanezumab 10 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 8	-0.00 units on a scale	Standard Deviation 2.71
Tanezumab 10 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Baseline	1.14 units on a scale	Standard Deviation 3.32
Tanezumab 10 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 2	0.14 units on a scale	Standard Deviation 2.28
Tanezumab 10 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 4	-0.16 units on a scale	Standard Deviation 2.2
Tanezumab 10 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 12	-0.12 units on a scale	Standard Deviation 2.67
Tanezumab 10 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 16	-0.21 units on a scale	Standard Deviation 2.69
Tanezumab 10 mg + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 24	-0.21 units on a scale	Standard Deviation 2.69
Naproxen + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 4	-0.25 units on a scale	Standard Deviation 1.71
Naproxen + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 24	-0.34 units on a scale	Standard Deviation 1.7
Naproxen + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 16	-0.34 units on a scale	Standard Deviation 1.73
Naproxen + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 2	-0.20 units on a scale	Standard Deviation 1.65
Naproxen + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Baseline	1.43 units on a scale	Standard Deviation 3.23
Naproxen + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 12	-0.25 units on a scale	Standard Deviation 1.58
Naproxen + Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24	Change at Week 8	-0.27 units on a scale	Standard Deviation 1.4

Other Pre-specified

Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities

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.

Time frame: Day 1 (Baseline) up to Week 24

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 1	35 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 2	8 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 3	1 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 4	13 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 5	1 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 6	1 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 7	29 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 8	2 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 9	13 Participants
Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 10	2 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 3	0 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 9	18 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 4	16 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 5	3 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 6	0 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 7	25 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 10	1 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 8	2 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 1	39 Participants
Tanezumab 5 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 2	3 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 8	3 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 7	28 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 10	1 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 1	38 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 4	13 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 6	2 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 9	21 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 2	5 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 5	2 Participants
Tanezumab 10 mg + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 3	3 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 5	2 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 8	1 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 6	0 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 10	1 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 7	27 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 2	1 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 3	1 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 4	9 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 1	45 Participants
Naproxen + Placebo	Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Criterion 9	21 Participants

Other Pre-specified

Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities

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.

Time frame: Day 1 (Baseline) up to Week 24

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities	2 Participants
Tanezumab 5 mg + Placebo	Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities	0 Participants
Tanezumab 10 mg + Placebo	Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities	2 Participants
Naproxen + Placebo	Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities	3 Participants

Other Pre-specified

Number of Participants With Laboratory Test Abnormalities

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).

Time frame: Day 1 (Baseline) up to Week 24

Population: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Laboratory Test Abnormalities	146 Participants
Tanezumab 5 mg + Placebo	Number of Participants With Laboratory Test Abnormalities	155 Participants
Tanezumab 10 mg + Placebo	Number of Participants With Laboratory Test Abnormalities	139 Participants
Naproxen + Placebo	Number of Participants With Laboratory Test Abnormalities	162 Participants

Other Pre-specified

Number of Participants With Positive Anti-Drug Antibody (ADA) Level

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.

Time frame: Baseline, Week 8, 16, 24

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Baseline	1 Participants
Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Week 8	1 Participants
Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Week 16	0 Participants
Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Week 24	1 Participants
Tanezumab 5 mg + Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Week 24	1 Participants
Tanezumab 5 mg + Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Baseline	1 Participants
Tanezumab 5 mg + Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Week 16	0 Participants
Tanezumab 5 mg + Placebo	Number of Participants With Positive Anti-Drug Antibody (ADA) Level	Week 8	0 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 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.

Time frame: Day 1 (Baseline) up to Week 24

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

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Adverse Events	99 Participants
Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Serious Adverse Events	8 Participants
Tanezumab 5 mg + Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Serious Adverse Events	7 Participants
Tanezumab 5 mg + Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Adverse Events	107 Participants
Tanezumab 10 mg + Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Adverse Events	122 Participants
Tanezumab 10 mg + Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Serious Adverse Events	6 Participants
Naproxen + Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Adverse Events	104 Participants
Naproxen + Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)	Serious Adverse Events	5 Participants

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026

Tanezumab In Osteoarthritis Of The Knee (2)

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Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)

Amount of Rescue Medication Taken

Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)

Number of Days Participants Used Rescue Medication

Percentage of Participants Who Used Rescue Medication

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)

Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)

Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)

Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)

Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)

Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)

Time to Discontinuation Due to Lack of Efficacy

Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24

Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities

Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities

Number of Participants With Laboratory Test Abnormalities

Number of Participants With Positive Anti-Drug Antibody (ADA) Level

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