Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'Number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Average daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their average bladder pain due to interstitial cystitis/painful bladder syndrome (IC/PBS) over the past 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Missing values were imputed using baseline observation carried forward (BOCF) method.

Worst daily pain score was defined as the mean of the last 7 daily diary pain ratings prior to each assessment time point. Participants rated their worst bladder pain due to IC/PBS over the past 24 hours on an 11-point NRS ranging from 0 = no bladder pain to 10 = worst possible bladder pain.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Participants answered: "Considering all the ways your bladder condition (IC/PBS) affects you, how are you doing today?" Participants responded on a 5-point scale where 1 = very good and 5 = very poor.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Participants were asked: "compared to when you began this trial, how would you rate your IC/PBS symptoms now?" Participants responded by using a 7-point symmetric scale where 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, and 7 = markedly improved.

ITT analysis set. Missing values were imputed using last observation carried forward (LOCF) method. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure and 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

The micturition frequency per 24 hours was calculated from the sum of voids divided by the diary period over which they were collected.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

The nocturnal frequency per 24 hours was defined as the number of voids after going to bed and before getting up (the times of going to bed and getting up were recorded in the diary). The nocturnal micturition per 24 hours was calculated as the sum of voluntary voids that occurred during a night's sleep, divided by the number of nights over which this was collected.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

The micturition urgency frequency per 24 hours was calculated as the sum of urgency episodes (when participant had to rush to get to the bathroom to urinate) occurring during the diary period when this was measured, divided by the number of days over which they were recorded.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Participants completed 7-item questionnaire assessing their urge to urinate over the past 24 hours. The items were assessed on a 5-point response scale ranging from 0 (never) to 4 (always). Urge to urinate was calculated as the total of the 7 'urge' items with a minimum total score of 0 and a maximum total score of 28. Higher scores indicated greater symptom severity. An average was determined from the 3 days recorded in the 7-day diary period prior to each assessment time point.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Mean volume voided per micturition was calculated as the total urine volume voided during the diary period when this was measured over 1 day, divided by the number of voids (with non missing volumes) during that day.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

The ICSI contained 4 questions that measured symptom severity including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI was rated on a 0-5 scale. The sum of the individual question ratings was the total score for the ICSI. Total scores ranged from 0 to 20, with higher scores indicating greater symptom severity and bother.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

BPI-sf is a 7-item self-administered questionnaire to assess the pain severity and pain interference on daily functions. Pain Severity Index (PSI) is an average of Questions 2-5 which measured the severity of pain (worst, least, average, right now) over past 24-hours on an 11-point scale (0=no pain to 10=pain as bad as you can imagine). Pain Interference Index (PII) is an average of 7 pain interference items of Question 7 that measured the level of interference of pain on daily function (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life) on an 11-point scale (0=did not interfere to 10=completely interfered). Pain Severity Index and Pain Interference Index total scores ranged from 0 to 10, where higher scores indicate greater pain or greater interference.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Participant global satisfaction is assessed using Patient Reported Treatment Impact (PRTI) which is a self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "Overall, how satisfied are you with the drug that you received since you entered this trial?" Participant's response is rated on a 5-point scale where 1=extremely dissatisfied (dissatisf), 2=dissatisfied, 3=neither satisfied nor dissatisfied (satisfy/dissatisfy), 4=satisfied and 5=extremely satisfied. Number of participants with each response is reported.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Participant global preference is assessed using PRTI which is self-administered questionnaire containing 4 items to assess participant satisfaction, previous treatment (T/T), preference and willingness to continue using study medication. Participant reported previous T/T under following categories: lifestyle interventions, physical therapies, toileting programs, drug given into bladder, drug taken by mouth, surgery, and no T/T. Participant preference was assessed on a 5-point scale where, 1=No, I definitely prefer my prior T/T (Def Pref Prior), 2=I have a slight preference for my prior T/T (Slight Pref Prior T/T), 3=I have no preference either way (No preference), 4=I have a slight preference for the drug that I am receiving now (Slight Pref Current), 5=Yes, I definitely prefer the drug that I am receiving (Def Pref Current Drug) now. Number of participants under each of the categories is reported. For previous T/T, a single participant may be represented in more than 1 category.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Participant willingness to re-use study medication is assessed using PRTI which is a self-administered questionnaire containing four items to assess participant satisfaction, previous treatment, preference and willingness to continue using the study medication. Participants were asked: "In the future, would you be willing to use the same drug that you have received since you entered this trial for your chronic prostatitis?" Participants responded on 5-point scale where, 1=No, I definitely would not want to use the same drug again (definitely not want), 2=I might not want to use the same drug again (might not want), 3=I am not sure (not sure), 4=I might want to use the same drug again (might want), 5=Yes, I would definitely want to use the same drug again (definitely want).

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

PBIC-QoL: 25-item questionnaire to assess impact of IC/PBS on health related quality of life over past 7 days. PBIC-QoL included 17 items (Items 2, 5, 8, 11, 14, 18, 20 and 21 did not form part of final instrument), of which 13 were divided into 3 dimensions: activity limitations (Items 1, 3, 4, 6, 7), impact on emotional wellbeing (Items 13, 15, 16, 17, 19), impact on sleep (Items 22, 23, 24). Four items: Item 9 (impact on going out with friends), Item 10 (impact on concentration), Item 12 (impact on eating and drinking), Item 25 (impact on sex life) were scored separately to dimension scores as single items. Items were scored from 4 'not at all' to 0 'extremely difficult' or 'a very great deal'. Eight items included a 'not applicable' response option. Dimension scores ranged from 0 to 4, higher score indicate better quality of life. Total score=sum of the dimension and single item scores, ranged from 0 to 28, higher score indicated better quality of life.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

For inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.

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

In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

In case of inadequate pain relief or worsening symptoms of IC/PBS, participants took acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) as rescue medication.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

In case of inadequate pain relief or worsening symptoms of IC/PBS, acetaminophen up to 3000 mg per day (1500 mg/day for Japanese population) could be taken as rescue medication.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Serum samples were analyzed for total NGF using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric method (IA/LC/MS/MS) method.

ITT analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

A neurological examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.

ITT analysis set. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

The NIS constituted the sum of 37 standard items of neuromuscular examination used to assess the muscle strength, reflexes and sensation. Each item was scored separately for left and right sides. Components of muscle weakness (24 items) were scored on a scale from 0 (normal) to 4 (paralysis), with higher score = more weakness; components of reflexes and sensation (13 items) scored on a scale with 0 = normal, 1 = decreased or 2 = absent. Total NIS score ranged from 0 to 244, a higher score indicate more impairment.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Systolic Blood Pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. Diastolic Blood Pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Following parameters were analyzed for ECG: RR interval, PR interval, QRS complex, QT interval, QT interval corrected using the Fridericia formula (QTcF), and QT interval corrected using the Bazett's formula (QTcB).

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

PVR volume is an objective assessment of the amount of urine left in the bladder after normal urination and will monitor whether the active treatment is having an adverse effect on lower urinary tract voiding function. The PVR volume assessed using trans-abdominal ultrasound (e.g., bladder scanner) with the participant in a supine position immediately after voluntary urination.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Urine was tested for specific gravity, pH, protein, glucose, ketones, blood, bilirubin, nitrites, and leukocyte, esterase using a urine dipstick. Number of participants with a laboratory abnormality meeting specified criteria: specific gravity (<1.003 and >1.030), urine pH (<4.5 and >8), protein (>=1 value in qualitative test), glucose (>=1 value in qualitative test), ketones (>=1 value in qualitative test), blood (>=1 value in qualitative test), bilirubin (>=1 value in qualitative test), nitrites (>=1), and leukocyte esterase (>=1) are reported.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Laboratory examination included hematology, liver function, renal function, lipids, electrolytes, clinical chemistry, and urinalysis. Reported results include abnormal laboratory findings without regard to baseline abnormality.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication.

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). In this outcome measure number of participants with presence of anti-tanezumab antibodies are reported.

Safety analysis set included all randomized participants who had received at least 1 dose of study medication. Here 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure. 'number analyzed' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.